By Jeffrey K. Shapiro –

FDA is authorized by the Federal Food, Drug, and Cosmetic Act of 1938, as amended (FDCA) to regulate the labeling of all medical devices and the advertising only of “restricted devices.”  (21 U.S.C. §§ 352(a), 352(q) and (r).)  FDA does have authority to take the advertising of non restricted devices into account in determining intended use (21 C.F.R. § 801.4), but it does not otherwise have authority to regulate their advertising. 

FDA creates restricted devices in two ways.  One is by issuing regulations designating particular device types as restricted.  Only two such regulations are on the books, one for hearing aids and the other for analyte specific reagents (ASRs).  (21 C.F.R. § 801.420; id. § 801.421; id., § 809.30.)  

The other way for FDA to create restricted devices is by embedding such designations in orders granting premarket application (PMA) approval to Class III devices.  (21 U.S.C. §§ 360e(d)(1)(B)(ii), 360j(e).)  Since FDA does so routinely, it is fair to say that virtually all Class III devices that have received PMA approval are restricted.

Accordingly, no Class I or Class II devices are restricted except for hearing aids and ASRs. Additionally, the handful of remaining Class III preamendment devices are not restricted, because they are not subject to a PMA approval order.

What does this discussion have to do with the Internet?  Given that most devices are not restricted, a crucial question is whether promotion on the Internet is “labeling” or “advertising.”  If the former, then FDA has authority to regulate such promotion.  (21 U.S.C. §§ 321(n), 352(a) & 352(f); 21 C.F.R. § 801.109(d).)  If the latter, then FDA lacks such authority.

In the early years of the new century, FDA resisted calls to declare whether the Internet was labeling or advertising.  As it turns out, the Internet enables communication in a variety of ways as it continues to evolve.  At the turn of the century, for example, web sites were predominant and various social media platforms that are ubiquitous today (e.g., Twitter, Facebook) had not yet been developed or had not taken hold.  So it turns out that FDA was prudent to resist calls for a sweeping determination as to whether the Internet as a whole would be considered labeling or advertising for regulatory purposes.  It is quite likely that different areas of the Internet could be considered labeling or advertising depending upon their nature and functionality, and new judgments may be required as the Internet continues to evolve.

In keeping with this wait and see approach, FDA has issued no Internet specific regulations and few such guidances.  Last June, however, FDA did issue two draft guidances focused on social media platforms on the Internet.  The first draft guidance discussed presentation of risk/benefit information on internet based social media platforms with character space limitations (“Character Space Guidance”).  The other one concerned efforts by firms to correct third party misinformation on these platforms (“Misinformation Guidance”).  We blogged about these draft guidances here.

The Character Space Guidance is focused on “electronic/digital platforms that are associated with character space limitations – specifically on the Internet and through social media or other technological venues” (p. 1).  As examples, FDA cites Tweets on Twitter and online paid search, such as sponsored links on search engines such as Google and Yahoo (id.).

The Misinformation Guidance  is less exacting about the venue.  It applies to “information . . . created or disseminated by independent third parties on the Internet or through social media or other technological venues . . ., regardless of whether that misinformation appears on a firm’s own forum or an independent third party forum or website” (p. 1).  Such venues may include Internet/social media platforms that allow for real time interaction or those where communication is asynchronous (see id., p. 3).

In Section II of each draft guidance, there is a summary of FDA’s authority over device and drug labeling and advertising, and it is generally consistent with the scheme described above.  In particular, FDA expressly notes that it has authority over the labeling of all medical devices and the advertising only of restricted devices. 

The draft guidances do not, however, take the obvious next step and analyze whether the portions of the Internet under discussion are labeling or advertising.  Interestingly, Section VI of the Character Space Guidance provides examples applying drug advertising requirements to tweets and sponsored links, among others.  The Section VI discussion, therefore, could be read to imply that FDA considers at least some aspects of the Internet covered by the draft guidances to be advertising.  Another hint at FDA’s position in the Character Space Guidance, p. 4, n.9, is a statement that “encourages” firms selling non restricted devices to follow the guidance, implying that such devices may not be subject to it.

What comes through most clearly, however, is that FDA has declined to forthrightly state its position.  This coy approach is unfortunate, because the answer is crucial to whether the enforcement position in these draft guidances applies to most medical devices. 

It is one thing to refrain from general pronouncements on the status of the Internet as a matter of prudence.  It is quite another to fail to answer an obvious question implicated by a draft guidance directed at a specific portion of the Internet (i.e., social media platforms).  Having chosen to provide guidance with respect to social media platforms, FDA should have indicated whether they consider these portions of the Internet to be labeling or advertising.

Absent such guidance, this blog post will try to answer the question.  This task requires some guesswork, because the statute and regulations have not been updated for the Internet.  But the alternative is complete confusion about whether the draft guidances apply to non-restricted medical devices.

Under the FDCA, “labeling” means “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.”  (21 U.S.C. § 321(m).)  As FDA notes in the draft guidances, “accompany” has been read broadly for more than half a century to include materials that textually supplement or explain an article, even if not physically attached to it.  Kordel v. United States, 335 U.S. 345, 350 (1948).

The FDCA does not define advertising, but FDA long ago adopted a regulation giving examples of promotion that would be considered advertising:  “Advertisements [subject to the FDCA] . . . include advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems.”  21 C.F.R. § 202.1(l)(1).  (The regulation nominally applies to drugs, but FDA has long considered it applicable to devices as well.  It is not clear exactly what was intended by the intriguing reference to advertisements broadcast through “telephone communication systems.”)

Obviously, these examples were provided prior to the development of the Internet and social media platforms.  But an “advertisement” generally means:  “A notice or announcement in a public medium promoting a product, service, or event or publicizing a job vacancy” (emphasis added).  This definition is consistent with the examples provided in the regulation, e.g., placing an advertisement in a print journal or running a radio advertising spot are both ways in which a product may be promoted in a public medium.

The next subsection of the same regulation also provides examples of labeling:  “Brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion picture films, film strips, lantern slides, sound recordings, exhibits, literature, and reprints. . . .”  21 C.F.R. § 202.1(l)(2).  In these cases, rather than placing a notice or announcement in a public medium being used for a variety of messages, such as a newspaper or radio channel, it would appear that the message and the medium are essentially coterminous, and the sponsor disseminates it to the prospective customers.  A brochure, for example, would typically consist entirely of a sponsor’s discussion of its products, and would be disseminated by the sponsor as a handout or mailer.

When a sponsor promotes a device with a tweet, or as a paid link on Google search results, which of these archetypes does such messaging most closely resemble?  What about if the sponsor posts a reply to misinformation about its products on a public bulletin board?

One could argue that these activities most closely resemble advertising.  A paid link on a Google search results page seems much like a traditional advertisement, with the search results page taking the place of a classified advertising in a newspaper.  A sponsor issuing a tweet or posting a reply to a statement in a chat room is also essentially making an announcement in a public medium.  That is the classic definition of advertising.  However, Internet technology does tend to break down the pure separation of labeling and advertising.  For example, a tweet could link to a product brochure that is itself labeling (and, therefore, should comply with the requirements for labeling). 

Still, it is not unreasonable to see social media platforms as a kind of digital public square into which a sponsor steps to promote its medical devices.  If this view is accepted, then such communications are advertising.  Accordingly, the draft guidances would not apply to non restricted medical devices (i.e., almost all Class I and Class II devices).

It may be that FDA would disagree with this analysis.  Rather than allowing uncertainty to persist, FDA should state its position openly.  It would also be helpful for Congress to update the existing statutory authority for the Internet age.  That would allow FDA to develop a considered policy, as opposed to the somewhat arbitrary exercise of extrapolating the existing statutory and regulatory definitions to new Internet technology – or worse, avoiding discussion of the issue altogether.

By Kurt R. Karst –

Thanks to everyone who participated in our “30 for 30” Hatch-Waxman Trivia!  Based on the corrrespondence we received since posting the trivia questions earlier this week, FDA Law Blog readers enjoyed the trip down memory lane. . .  and were entertained along the way.  We know you are chomping at the bit to see the answers, so without further ado, we give you the answers to each of the trivia questions.       

Q1:   What U.S. Senator is a musician, songwriter and producer, a member of ASCAP, and whose works have been recorded by Gladys Knight, Donny Osmond and Brooks and Dunn, among others?

A:  Senator Orrin Hatch (R-UT) (see here and here)

Q2:   When standing at the base of the U.S. Capitol, this dome (pictured below) stands at 93.5 feet above sea level.  To whom does this dome belong?

A.   Representative Henry Waxman (D-CA).  He stands at 5.5 feet tall and the base of the U.S. Capitol is 88 feet above sea level.

Q3:   President Ronald Reagan returned from where before signing into law the Drug Price Competition and Patent Term Restoration Act of 1984 in the Rose Garden on September 24, 1984?

A. New York, New York after addressing the 39th Session of the United Nations General Assembly.  President Reagan commented during the signing of Hatch-Waxman: “I just returned from New York — literally minutes ago — where I addressed the United Nations. . . .”

Q4: Who has a lower “Bacon Number”: President Ronald Reagan, Sen. Orrin Hatch, or Rep. Henry Waxman?

A. This is, of course, a reference to prolific Hollywood character actor Kevin Bacon and the game wherein movie buffs challenge each other to find the shortest path between an arbitrary actor and Kevin Bacon.  President Reagan, Sen. Hatch, and Rep. Waxman have all appeared in movies.  According to the Oracle of Bacon, all three are tied with a “Bacon Number” of 2.  Here’s the path to Kevin Bacon for each:

Ronald Reagan
was in
Brother Rat (1938)
with
Eddie Albert
was in
The Big Picture (1989)
with
Kevin Bacon

Henry Waxman
was in
MoveOn: The Movie (2009)
with
Moby
was in
Come Together: A Night for John Lennon's Words and Music (2001) 
with
Kevin Bacon

Orrin G. Hatch
was in
Traffic (2000)
with
John Slattery
was in
The 60th Primetime Emmy Awards (2008)
with
Kevin Bacon

Q5: Were rain umbrellas needed in the Rose Garden on September 24, 1984?

A: No.  According to the Farmers’ Almanac, the high temperature in Washington, DC that day was 88°F with no precipitation.  And, according to President Reagan, it was hot.  He commented during the signing ceremony: “I don't know why it is on some of these hot rallies out in the countryside the chairs are black instead of white, and they get very warm when you stand too long.”

Q6: What is the typographical error in the text of FDC Act § 505(j) that was never corrected?  (Hint: The affected section was replaced by the 2003 Medicare Modernization Act (“MMA”).)

FDC Act § 505(j)(5)(B)(iv), as enacted states: 

If the application contains a certification described in subclause (IV) of paragraph (2)(A)(vii) and is for a drug for which a previous application has been submitted under this subsection continuing such a certification, the application shall be made effective not earlier than one hundred and eighty days after-

(I) the date the Secretary receives notice from the applicant under the previous application of the first commercial marketing of the drug under the previous application, or

(II) the date of a decision of a court. ..holding the patent which is the subject of the certification to be invalid or not infringed,

whichever is earlier. [Emphasis added].

The word “continuing” should have been “containing,” as some courts have recognized.  See, e.g., Purepac Pharm. Co. v. Friedman, 162 F.3d 1201, 1203 n.3 (D.C. Cir. 1998); Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1064 n.3 (D.C. Cir. 1998).

Q7: What is the significance of January 1, 1982 to the Orange Book?

FDC Act § 505(j)(7)(A)(i)(II) requires FDA to include in “the list” (i.e., the Orange Book) the date of approval and application number of drug products approved after 1981.  Information on products approved prior to 1981 may be included in the Orange Book, however, no date of approval is included.  Instead, the approval date field in the printed version of the Orange Book is left blank.   In the electronic version of the Orange Book, products approved prior to January 1, 1982 contain the phrase “Approved prior to Jan 1, 1982.”

Q8: What is the significant difference between ANDA No. 076933 and ANDA No.  076934?  (The answer is neither “1,” nor the drug name.) 

A. ANDAs with a number less than or equal to 076933 are pre-MMA applications, and ANDAs with a number equal to or greater than 076934 are post-MMA applications.

Q9:   What pharmaceutical industry trade organization executive referred to the pre-Hatch-Waxman hurdles to generic competition of post-1962 drugs as an “iron curtain”?

A: William F. Haddad, President of the Generic Pharmaceutical Industry Association, according to a June 8, 1984 article in The Washington Post, titled “FDA Lets Some Drugs Take Effect Slowly”: “But until the law is changed, the FDA will continue approving drugs according to the old rules — a system that William F. Haddad, president of the Generic Pharmaceutical Industry Association, and other critics say acts as an ‘iron Curtain’ that makes it difficult to get new generic drugs approved.”

Q10:  What almost-U.S. President opposed efforts to pass legislation that would have extended brand-name drug patents without creating a generic drug approval process?

A: Then-Representative Albert Gore, Jr. (D-TN).  See The Push to Protect Patents on Drugs; The Drug Industry Nearly Won Last Year, but Then the Political Winds Changed. (Science 1983:  Vol. 222 no. 4624 pp. 593-595). 

Q11: Donald Hare, R.Ph., who has since retired from FDA, is sometimes referred to as the Father of the Orange Book.  To whom does the distinction of Mother of the Orange Book – or at least Mother-in-Law – belong?

A: CAPT Mary Ann Holovac, R.Ph., who oversaw the publication for nearly 25 years, until December 2013.

Q12:  As of today, what is the longest, unexpired period of non-patent exclusivity listed in the Orange Book?

A: A period of GAIN exclusivity expiring on August 6, 2024 is listed for NDA No. 206334 for ORBACTIV (oritavancin diphosphate) Lyophilized Powder Injection.  This is the latest of the few periods of GAIN exclusivity FDA has granted.  The other GAIN Act approvals are NDA Nos. 205435 and 205346 for SIVEXTRO (tedizolid phosphate) (GAIN exclusivity expiring on June 20, 2024), and NDA No. 021883 for DALVANCE (dalbavancin HCl) (GAIN exclusivity expiring on May 23, 2024).  

Q13:   When were Reference Listed Drug (“RLD”) designations added to the Orange Book?

A: RLD designations (identified by a “+” in the paper version of the Orange Book) first appeared with publication of the 12th Edition (1992).

Q14:  When was an electronic Orange Book search function added to FDA’s website?

A: An electronic Orange Book search function was added to FDA’s website on October 31, 1997.  Beginning in 1998, current patent listings for approved drug products could be obtained from the electronic Orange Book through a search by active ingredient, proprietary name, application holder, or application number.  Since February 2005 (25th Edition), FDA has provided daily electronic Orange Book product updates, and made the volume available in a downloadable PDF format. 

Q15: What is the “Blue Book”?

A: Before the Orange Book came into existence, there was a predecessor publication known as the “Blue Book,” which was a list of manufacturers with approved NDAs and ANDAs (or manufacturers who were named as distributors in those applications) for drug products having known or potential bioequivalence problems.

Q16: Prior to FDA’s formal creation of Orange Book patent listing forms (Form FDA 3542a and Form FDA 3542) in 2003, did FDA offer any informal guidance to NDA sponsors on patent listing? 

A: Yes.  FDA provided a Patent Submission Sample Format to sponsors who requested it. 

Q17:  Can you identify 10 types of non-patent marketing exclusivities (or non-patent exclusivity extensions) recognized by the FDC Act?

A: (1) 5-year New Chemical Entity Exclusivity; (2) 3-year new clinical investigation exclusivity for an original NDA; (3) 3-year new clinical investigation exclusivity for a supplemental NDA; (4) 10-year window exclusivity; (5) 2-year window exclusivity; (6) 5-year Generating Antibiotic Incentives Now Act exclusivity; (7) 6-month pediatric exclusivity; (8) 5-year enantiomer exclusivity; (9) QI Act antibiotic exclusivity; (10) 180-day generic drug exclusivity; (11) 7-year orphan drug exclusivity

Q18:  How long did it take after the December 8, 2003 enactment of the MMA for a member of Congress to propose a revision to the law (and specifically to the 180-day exclusivity forfeiture provisions)?

A: One day.  On December 9, 2003, Sen. Hatch suggested changes to the failure-to-market 180-day exclusivity forfeiture provision.  See 149 Cong. Rec. S16104 (daily ed. Dec. 9, 2003) (statement of Sen. Orrin Hatch).

Q19:  What U.S. law is modeled after the Hatch-Waxman Amendments, and how long has it taken FDA to issue implementing regulations?

A: The Generic Animal Drug and Patent Term Restoration Act of 1988, Pub. Law No. 98-417, 98 Stat. 1585 (1988), which is the Hatch-Waxman equivalent for generic animal drugs.  FDA has not yet proposed regulations to implement the law.

Q20:  How many times has FDA used its “active pursuit” regulation at 21 C.F.R. § 314.107(c)(3) (“[I]f FDA concludes that the applicant submitting the first application is not actively pursuing approval of its abbreviated application, FDA will make the approval of subsequent [ANDAs] immediately effective if they are otherwise eligible for an immediately effective approval.”) to effectively take away a first applicant’s 180-day exclusivity eligibility?

A: None.

Q21:  What case (and involving what drug) was the first judicial test of the 3-year exclusivity provisions of the Hatch-Waxman Amendments?

A: Zenith Labs., Inc. v. Bowen, Case No. 85-cv-3646 (D.N.J. 1986), which involved the drug Tolazamide.

Q22:  Who is Gary P. Jordan?

A: Gary P. Jordan is the the first assistant U.S. attorney who prosecuted a case arising from the so-called “generic drug scandal.” 

Q23:  Who is Marion J. Finkel?

A: Marion J. Finkel is credited with developing the framework for the so-called “paper NDA,” which is a predecessor to the 505(b)(2) NDA. 

Q24:  What is the only instance in which a court has ordered FDA to approve an ANDA during another sponsor’s period of 180-day exclusivity? 

A: In Watson Laboratories, Inc. v. Sebelius, et al., Case No. 12-1344 (ABJ) (D.D.C. Oct. 22, 2012), which concerned 180-day exclusivity for generic ACTOS (pioglitazone) under the pre-MMA statute, the district court overruled FDA’s determination that Watson was not eligible to share in 180-day exclusivity because the company was not the first (or among the first) to amend its pending ANDA to convert a patent certification to Paragraph IV.  Instead, the district court ruled that Watson was entitled to share in another applicant’s 180-day exclusivity period, because FDA’s long-standing interpretation of the FDC Act was contrary to the terms of the statute, and ordered the Agency to approve Watson’s ANDA.  FDA appealed the decision to the U.S. Court of Appeals for the District of Columbia Circuit (Docket Nos. 12-5332 & 12-5342), where a motion for vacatur (based on mootness) was ultimately granted. 

Q25:  What is the only instance in whch FDA was faced with a leap year NCE NDA approval?

A: FDA approved PRISTIQ (desvenlafaxine) Extended-Release Tablets under NDA No. 021992 in a leap year, on February 29, 2008, and granted NCE exclusivity expiring in a non-leap year, on March 1, 2013.  FDA added a note to the Orange Book stating: “Applications referencing NDA 021992 Pristiq (Desvenlafaxine Succinate) and challenging the listed patent may be received by the Agency beginning on Feb 29, 2012, four years from the NDA approval date” (see our previous post here). 

Q26:  FDA’s regulation at 21 C.F.R. § 314.94(a)(12)(viii) states, in relevant part, “an applicant who has submitted a paragraph IV patent certification may not change it to a paragraph III certification if a patent infringement suit has been filed against another paragraph IV applicant unless the agency has determined that no applicant is entitled to 180-day exclusivity or the patent expires before the lawsuit is resolved or expires after the suit is resolved but before the end of the 180-day exclusivity period.”  What is the status of this regulation?

A: This regulation has not been enforced by FDA for several years.  The regulation was promulgated in the early 1990s at a time when it was unclear to FDA whether a first-filer’s period of 180-day exclusivity could extend beyond the life of the patent(s) on which eligibility to exclusivity was based.  At the time, FDA was concerned that a subsequent ANDA Paragraph IV filer would convert its certification in an effort to circumvent a first-filer’s 180-day exclusivity.  As such, the above passage from 21 C.F.R. § 314.94(a)(12)(viii) was included to guard against that possibility.   Subsequently, FDA and the courts have ruled that 180-day exclusivity cannot extend beyond the expiration of the patent(s) on which such exclusivity is based.  As such, the need for this regulation has, as a general matter, been outlived.  (The only time such a prohibition might still arise is in the case where an ANDA sponsor submits an ANDA with a Paragraph IV certification during the NCE-1 year, and then, after FDA receives – i.e., files – the ANDA, converts that Paragraph IV certification to a Paragraph III certification.  In that case, the conversion would remove the basis for the ANDA submission in the first place.  But even in this case, FDA still has not taken action to enforce the general prohibition at 21 C.F.R. § 314.94(a)(12)(viii).)

Q27: Can a single patent use code serve as the basis for a split Paragraph IV certification and “section viii” statement? (This question is a nod to recent controversies involving patent use codes.)

A: Yes.  ANDA No. 076565 for Venlafaxine HCl Extended-Release Capsules included such a split certification with respect to the “U-459” (TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER) patent use code associated with U.S. Patent No. 6,419,958.

Q28:  In what case was the U.S. Patent and Trademark Office’s (“PTO”) longstanding interpretation of 35 U.S.C. § 156(a)(5)(A) concerning Patent Term Extensions (“PTE”) struck down?

A: On May 10, 2010, the U.S. Court of Appeals for the Federal Circuit issued its decision in PhotoCure v. Kappos, 603 F.3d 1372 (Fed. Cir. 2010) (and in a second case, Ortho-McNeil Pharm., Inc. v. Lupin Pharms., Inc., 603 F.3d 1377 (Fed. Cir. 2010)) concerning the proper interpretation of 35 U.S.C. § 156(a)(5)(A), which states that the term of a patent claiming a drug shall be extended from the original expiration date of the patent if, among other things, “the permission for the commercial marketing or use of the product . . . is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred.”  For several years, the PTO interpreted the term “product” in 35 U.S.C. § 156(a)(5)(A) to mean “active moiety” rather than “active ingredient.”  The Federal Circuit’s PhotoCure and Ortho-McNeil decisions say that the an “active ingredient” interpretation of the statute should be applied for PTE purposes. 

Q29:  What is the connection between the drugs INDOCIN (indomethacin) and CAPOZIDE (captopril and hydrochlorothiazide), U.S. Patent Nos. 3,849,549 (INDOCIN) and 4,217,347 (CAPOZIDE), and Title II of the Hatch-Waxman Amendments?

A: Both drugs and both patents were cited in a March 25, 1985 letter from Reps. Henry Waxman and Robert Kastenmeier (D-WI) to the PTO Commissioner as examples of drug products covered by a patent that the Congressmen did not believe should be granted a PTE because the drugs contain an active ingredient previously approved by FDA. 

Q30:  What patent concerning what drug led to a change in the PTE statute at 35 U.S.C. § 156 involving the deadline for submitting a PTE application to PTO?

A: U.S. Patent No. 5,196,404 covering ANGIOMAX (bivalirudin) (see our previous post here).

By James C. Shehan –

With the posting on Friday of a report, a special advisory bulletin and a podcast, the HHS OIG staked out some new ground in the healthcare fraud and abuse landscape.  The report shows that significant numbers of Medicare beneficiaries use copay coupons from drug companies.  The OIG believes that this situation could impose significant costs on the Medicare Part D program.  The OIG also believes that drug companies have the ability to change the situation.  Therefore, in the special advisory bulletin (SAB), the OIG cautions drug companies that they are at risk of sanctions if they fail to take “appropriate steps” to ensure that their copayment coupons do not induce the purchase of Medicare Part D drugs.  The SAB also recommends that companies work with CMS and other industry stakeholders to identify solutions, and that CMS coordinate such industry efforts.

Over the last decade, drug companies have dramatically increased their offering of copayment coupons.  This increased offering has paralleled the trend toward larger copayments for all drugs, but particularly for brand name drugs.  Copayment coupons have not been without controversy – in 2012 union health plans filed multiple lawsuits against nine drug companies alleging that their copay programs violated the antitrust laws and RICO (see our previous posts here and here).  The issue did not escape the notice of OIG, which it announced its plans to conduct a study in its 2014 work plan (see our post here).

The report bears the straightforward title of Manufacturer Safeguards May Not Prevent Copayment Coupon Use for Part D Drugs.  Noting that two previous surveys by third parties found that 6-7 percent of seniors reported using copay coupons, the OIG interviewed 30 large drug companies about their copay programs.  The OIG also spoke with CMS and various entities involved in claims processing.

The report contains four significant findings.  First, all of the manufacturers provided notices to beneficiaries and pharmacists that copayment coupons may not be used by Federal health care program beneficiaries, although sometimes these disclaimers are present in some coupon formats (e.g., print, electronic) but not others.  Second, most manufacturers use pharmacy claims edits to prevent use of copayment coupons by Part D beneficiaries.  Third, despite these safeguards, some copayment coupons are presented by Medicare beneficiaries and processed by drug companies.  Fourth, Part D plans and other healthcare entities cannot identify when copayment coupons are being used in any individual drug reimbursement claims – only the drug companies that issue the coupons can, and Medicare claims are often paid before coupons are processed. 

The conclusions that the OIG draws from the report are that the reliability of pharmacy claims edits needs to be improved and that the use and existence of coupons needs to be made transparent within the whole pharmacy claim process.  OIG recognizes that making these changes requires the coordination and cooperation of multiple stakeholders in the process, including CMS (whose input and concurrence the OIG sought and obtained).  But in the SAB, the OIG places the responsibility for currently ensuring that copay coupons do not violate the antikickback statute squarely upon the shoulders of the drug companies that issue copay coupons.  Interestingly, a footnote in the SAB states that pharmacies that accept coupons from Medicare beneficiaries may also face sanctions 

What remains unknown is how and when CMS will take up the OIG’s call to lead effort to make changes, and whether OIG enforcement actions may occur in this area, either before or after CMS takes action.

By Ricardo Carvajal & JP Ellison –

The U.S. Department of Justice recently announced the convictions of former officials and a broker of the Peanut Corporation of America (“PCA”) – the company at the heart an outbreak of salmonellosis five years ago that was traced to the company’s peanut products.  In particular, PCA owner Stewart Parnell was convicted of conspiracy, mail and wire fraud, obstruction of justice, and introduction of adulterated and misbranded food into interstate commerce.  The court has not set a date for sentencing.

According to DOJ’s press release, the trial ran for seven weeks and featured the testimony of 45 witnesses for the prosecution – including former operations managers who had already pled guilty to crimes arising from their roles in the sale of the products.  Among the schemes to defraud customers for which evidence was presented at trial was the falsification of certificates of analysis.  As we noted in a prior posting, the PCA case raised difficult questions about the adequacy of certain approaches to supplier verification – an element left out of the text of FDA’s proposed rule to implement FSMA’s preventive controls requirements.

Although the timing is almost certainly coincidental, it is not surprising that FDA has now proposed changes to the preventive controls rule for human food to require a receiving facility to “establish and implement a risk-based supplier program for those raw materials and ingredients for which the receiving facility has identified a significant hazard when the hazard is controlled before receipt of the raw material or ingredient” – with certain exceptions that we won’t belabor here.  There is some flexibility in the selection of appropriate verification activities, but the receiving facility must consider the following:

1. The hazard analysis, including the nature of the hazard, applicable to the raw material and ingredients;
2. Where the preventive controls for those hazards are applied for the raw material and ingredients – such as at the supplier or the supplier’s supplier;
3. The supplier’s procedures, processes, and practices related to the safety of the raw material and ingredients;
4. Applicable FDA food safety regulations and information relevant to the supplier’s compliance with those regulations, including an FDA warning letter or import alert relating to the safety of the food;
5. The supplier’s food safety performance history relevant to the raw materials or ingredients that the receiving facility receives from the supplier, including available information about results from testing raw materials or ingredients for hazards, audit results relating to the safety of the food, and responsiveness of the supplier in correcting problems; and
6. Any other factors as appropriate and necessary. Examples of factors that a receiving facility may determine are appropriate and necessary are storage and transportation practices.

For raw materials and ingredients, the receiving facility must conduct and document at least one of following activities initially and periodically:

• Onsite audits;
• Sampling and testing of the raw material or ingredient, which may be conducted by either the supplier or receiving facility.
• Review by the receiving facility of the supplier’s relevant food safety records; or
• Other appropriate supplier verification activities based on the risk associated with the ingredient and the supplier.

However, “when a hazard in a raw material or ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans,” the receiving facility must conduct an onsite audit initially and at least annually thereafter – unless the receiving facility can show that such auditing is unnecessary to control the hazard. 

Additional information on FDA’s proposed changes to the preventive controls rule and to several other rules (preventive controls for animal food, produce safety, and foreign supplier verification) is available here.

By Kurt R. Karst –  

It’s difficult to believe that almost 30 years have passed since President Ronald Reagan signed into law the Drug Price Competition and Patent Term Restoration Act of 1984 on September 24, 1984.  So much in Hatch-Waxman law (or Waxman-Hatch law if you are a food and drug attorney “of a certain age”) – and the world – has changed since that signing in the Rose Garden.  President Reagan is no longer with us; Representative Henry Waxman (D-CA), now 74 years old, is retiring after the conclusion of the 113th Congress; Senator Orrin Hatch (R-UT), now 80 years old, is still going strong, but announced that he plans to retire in 2018. 

If you’re a regular reader of this blog, then you know that we have more than a passing interest in the Hatch-Waxman Amendments.  It’s a bit of an obsession.  And we also have a thing for anniversaries.  Over the past couple of years we’ve celebrated the 30th Anniversary of the Orphan Drug Act (see our post here), and the 75th Anniversary of the enactment of the FDC Act (see our post here).  This blogger also authored an article for the William Mitchell Law Review’s Hatch-Waxman 30th Anniversary issue providing the first ever analysis of FDA’s nearly 30-year track record of responding to ANDA suitability petitions (see our post here). 

Five years ago we celebrated the 25th Anniversary of the Hatch-Waxman Amendments with a trivia contest (see our post here).  We came up with a mere 20 questions for FDA Law Blog readers to answer.  It’s five years later and once again we’ve decided to challenge FDA Law Blog readers with Hatch-Waxman trivia.  This time we’re going “30 for 30.”  We had to dig deep . . . real deep . . . to come up with new trivia.  We hope you enjoy it!  We’ll reveal the answers in a separate post later this week.

Q1:   What U.S. Senator is a musician, songwriter and producer, a member of ASCAP, and whose works have been recorded by Gladys Knight, Donny Osmond and Brooks and Dunn, among others?

Q2:   When standing at the base of the U.S. Capitol, this dome (pictured below) stands at 93.5 feet above sea level.  To whom does this dome belong?

Q3:   President Ronald Reagan returned from where before signing into law the Drug Price Competition and Patent Term Restoration Act of 1984 in the Rose Garden on September 24, 1984?

Q4: Who has a lower “Bacon Number”: President Ronald Reagan, Sen. Orrin Hatch, or Rep. Henry Waxman?

Q5: Were rain umbrellas needed in the Rose Garden on September 24, 1984?

Q6: What is the typographical error in the text of FDC Act § 505(j) that was never corrected?  (Hint: The affected section was replaced by the 2003 Medicare Modernization Act (“MMA”).)

Q7: What is the significance of January 1, 1982 to the Orange Book?

Q8: What is the significant difference between ANDA No. 076933 and ANDA No.  076934?  (The answer is neither “1,” nor the drug name.) 

Q9:   What pharmaceutical industry trade organization executive referred to the pre-Hatch-Waxman hurdles to generic competition of post-1962 drugs as an “iron curtain”?

Q10:  What almost-U.S. President opposed efforts to pass legislation that would have extended brand-name drug patents without creating a generic drug approval process?

Q11: Donald Hare, R.Ph., who has since retired from FDA, is sometimes referred to as the Father of the Orange Book.  To whom does the distinction of Mother of the Orange Book – or at least Mother-in-Law – belong?

Q12:  As of today, what is the longest, unexpired period of non-patent exclusivity listed in the Orange Book?

Q13:   When were Reference Listed Drug (“RLD”) designations added to the Orange Book?

Q14:  When was an electronic Orange Book search function added to FDA’s website?

Q15: What is the “Blue Book”?

Q16: Prior to FDA’s formal creation of Orange Book patent listing forms (Form FDA 3542a and Form FDA 3542) in 2003, did FDA offer any informal guidance to NDA sponsors on patent listing? 

Q17:  Can you identify 10 types of non-patent marketing exclusivities (or non-patent exclusivity extensions) recognized by the FDC Act?

Q18:  How long did it take after the December 8, 2003 enactment of the MMA for a member of Congress to propose a revision to the law (and specifically to the 180-day exclusivity forfeiture provisions)?

Q19:  What U.S. law is modeled after the Hatch-Waxman Amendments, and how long has it taken FDA to issue implementing regulations?

Q20:  How many times has FDA used its “active pursuit” regulation at 21 C.F.R. § 314.107(c)(3) (“[I]f FDA concludes that the applicant submitting the first application is not actively pursuing approval of its abbreviated application, FDA will make the approval of subsequent [ANDAs] immediately effective if they are otherwise eligible for an immediately effective approval.”) to effectively take away a first applicant’s 180-day exclusivity eligibility?

Q21:  What case (and involving what drug) was the first judicial test of the 3-year exclusivity provisions of the Hatch-Waxman Amendments?

Q22:  Who is Gary P. Jordan?

Q23:  Who is Marion J. Finkel?

Q24:  What is the only instance in which a court has ordered FDA to approve an ANDA during another sponsor’s period of 180-day exclusivity? 

Q25:  What is the only instance in whch FDA was faced with a leap year NCE NDA approval?

Q26:  FDA’s regulation at 21 C.F.R. § 314.94(a)(12)(viii) states, in relevant part, “an applicant who has submitted a paragraph IV patent certification may not change it to a paragraph III certification if a patent infringement suit has been filed against another paragraph IV applicant unless the agency has determined that no applicant is entitled to 180-day exclusivity or the patent expires before the lawsuit is resolved or expires after the suit is resolved but before the end of the 180-day exclusivity period.”  What is the status of this regulation?

Q27: Can a single patent use code serve as the basis for a split Paragraph IV certification and “section viii” statement? (This question is a nod to recent controversies involving patent use codes.)

Q28:  In what case was the U.S. Patent and Trademark Office’s (“PTO”) longstanding interpretation of 35 U.S.C. § 156(a)(5)(A) concerning Patent Term Extensions (“PTE”) struck down?

Q29:  What is the connection between the drugs INDOCIN (indomethacin) and CAPOZIDE (captopril and hydrochlorothiazide), U.S. Patent Nos. 3,849,549 (INDOCIN) and 4,217,347 (CAPOZIDE), and Title II of the Hatch-Waxman Amendments?

Q30:  What patent concerning what drug led to a change in the PTE statute at 35 U.S.C. § 156 involving the deadline for submitting a PTE application to PTO?

By Karla L. Palmer –

Late last week, Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI), both members of the Senate Committee on Health, Education, Labor, & Pensions, announced the introduction of S. 2862, the “Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act.”  The legislation seeks to “streamline” and “increase transparency in the approval process” for controlled substances by creating a specific timeline for DEA to schedule certain controlled substances that have never before been marketed in the United States.  In March 2014, a somewhat similar bill was introduced in the House of Representatives (H.R. 4299; see our previous post here), also addressing the need for DEA to act promptly in making scheduling decisions for newly approved drugs. 

The prompt scheduling provisions of the legislation are the fallout of DEA’s very public delay in scheduling a drug subject to an exclusivity period (FYCOMPA™).  The delay prompted Eisai to first file a petition for a writ of mandamus requiring  DEA to make a scheduling decision so the drug could be marketed, and then to sue FDA (see our previous posts here and here). 

The bi-partisan bill seeks the following: 

• Amend the CSA to require that DEA schedule a drug or substance that has never been marketed in the United States within 45 days of receiving a scheduling recommendation from the Secretary of HHS.  This proposed provision is identical to H.R. 4299. 
• Hasten the development of new drug therapies by allowing researchers to indicate on their DEA application that the controlled substance will only be used for clinical trials of a drug.  This proposed provision is also identical to H.R. 4299. 

The following provisions are not included in previously introduced H.R. 4299:

• Clarify terminology in the CSA for the terms: “consistent with the public health and safety” and “imminent danger,” which, Senator Hatch claims, will “improve the ability of the DEA to work collaboratively with distributors and other stakeholders to prevent drug diversion.” This  change would define the statutory term “imminent danger” as follows:  In the “absence of an immediate suspension order, controlled substances will continue to be distributed or dispensed by a registrant who knows or should know . . . or has reason to believe that (A) the dispensing is outside the usual course of professional practice; (B) the distribution or dispensing poses a present or foreseeable risk of adverse health consequences or death due to the abuse or misuse of the controlled substances; or (C) the controlled substances will continue to be diverted outside of legitimate distribution channels.”  Note the “imminent danger” standard has recently been challenged in at least three DEA matters.  See Holiday CVS v. Holder, (Civ. No. 12-191) (D.D.C. Mem. Op. Mar. 16, 2012); Cardinal Health v. Holder (Civ. No 12-185) (D.D.C. Mem. Op. Mar. 7. 2012); Walgreen Company v. DEA (Civ. No. 12-1397) (D.C. Cir., filed Oct. 10, 2012). 
• Amend 21 U.S.C. § 824 (Denial, revocation or suspension of registration) to allow registrants who face having their registration revoked or suspended pursuant to an order to show cause  the opportunity to submit a corrective action plan within the time period set forth in the order (not less than 30 days).  Registrants subject to an immediate suspension order shall not be entitled to submit a corrective action plan, however.
• Require the Secretary of Health and Human Services – not later than one year after enactment – to submit a report to Congress assessing how enforcement activities may affect patient access to needed medications; issues with diversion; and identify how collaboration between agencies and stakeholders can benefit patients and prevent prescription drug abuse.  This section of the legislation requires collaboration among FDA, Centers for Disease Control and Prevention, DEA, and Office of National Drug Control Policy.  The report will require feedback from patient groups, pharmacies, drug manufacturers, common and contract carriers, hospitals, state attorneys general, law enforcement, insurance providers, and drug distributors. 

By Kurt R. Karst –      

There have been rumors floating around Washington, DC for a few months that efforts were afoot to introduce legislation to amend the FDC Act to address the availability of products subject to a restricted distribution program to generic drug and biosimilar manufacturers for purposes of conducting studies necessary to pursue approval of a marketing application.  Those rumors turned into reality with the September 18th introduction of H.R. 5657, the Fair Access for Safe and Timely Generics Act of 2014 (“FAST Generics Act”).  Introduced in the U.S. House of Representatives by Congressmen Steve Stivers (R-OH) and Peter Welch (D-VT), the bill would “increase consumer access to generic drugs, boost market competition and ultimately save consumers money,” according to a press release announcing the introduction of the FAST Generics Act.  The Generic Pharmaceutical Association, which sponsored a paper published in July 2014 on restricted distribution programs and generic drug competition, applauded the introduction of the bill in a press release.

In case you’re not familiar with the topic of the FAST Generics Act, the issue concerns drug and biological products covered by restricted distribution programs – either under a Risk Evaluation and Mitigation Strategies (“REMS”) program with Elements To Assure Safe Use (“ETASU”) under FDC Act § 505-1, or under a restricted distribution program adopted and implemented by a brand-name manufacturer.  In most cases, in order for a generic drug (or biosimilar) manufacturer to submit a marketing application to FDA, the company must first conduct studies comparing its proposed product to the brand-name reference product.  In order to do so, the generic drug manufacturer must first obtain reference product sample.  Normally drug product sample is easily obtained through various market channels.  Products under a restricted distribution program, however, are tightly controlled (often because of a safety concern) and are not readily available.  If a generic drug sponsor is unable to obtain sample for equivalence testing, then it is unable to seek marketing approval from FDA.

Current law states that “[n]o holder of an approved covered application shall use any element to assure safe use required by [FDA] under [FDC Act § 505-1(f)] to block or delay approval of an application under section 505(b)(2) or (j) or to prevent application of such element under [FDC Act § 505-1(i)(1)(B)] to a drug that is the subject of an [ANDA].”  In June 2009, Dr. Reddy’s Laboratories, Inc. submitted a Citizen Petition (Docket No. FDA-2009-P-0266) to FDA requesting that the Agency “establish procedures to facilitate the availability of generic versions of drug products subject to a [REMS] and enforce the FDC Act to prevent companies from using REMS to block or delay generic competition.”  FDA responded to the petition in August 2013 saying, among other things, that decisions to take enforcement action are made at the Agency’s discretion on a case-by-case basis and that FDA “agrees that issues related to ensuring that marketplace actions are fair and do not block market competition would be best addressed by the FTC,” to which FDA has been referring complaints related to restricted distribution programs. 

In 2012, as Congress was considering legislation that was ultimately enacted as the FDA Safety and Innovation Act (“FDASIA”), there was a push to amend the law to address REMS and generic competition.  Specifically Section 1131 of Senate-passed S. 3187 would have amended FDC Act § 505-1 to state that:

Notwithstanding any other provision of law, if a drug is a covered drug, no elements to ensure safe use shall prohibit, or be construed or applied to prohibit, supply of such drug to any eligible drug developer for the purpose of conducting testing necessary to support an application under [FDC Act § (b)(2) or § 505(j) or PHS Act § 351(k)] if the Secretary has issued a written notice described in paragraph (2), and the eligible drug developer has agreed to comply with the terms of the notice.

That provision was not enacted as part of FDASIA.  As one legislative bulletin issued at the time stated, “[s]ome controversy surrounded this provision since it could have [led] to the FDA forcing drug sales between brand and generic manufacturers.”  In addition, then-FTC Commissioner J. Thomas Rosch objected to including the provision in FDASIA.  Referring to both REMS legislation advocated by FTC staff that would “give the FTC jurisdiction to challenge the refusal of a pioneer drug company to provide product samples to generic manufacturers if the FDA determined that the generic company’s protocols were safe,” and to the REMS provisions in S. 3187, Commissioner Rosch commented that “[n]either proposal should be tacked on to other legislation on the Senate floor and should instead be considered by the Help Committee on their own merits” (see our previous post here). 

Meanwhile, issues concerning ETASU REMS, restricted distribution programs, and generic competition were being debated in court in the context of antitrust law (see our previous posts here, here, and here).  None of the earlier court challenges resulted in a decision, because the cases were settled.  Earlier this year, however, Mylan Pharmaceuticals Inc. filed a lawsuit alleging that Celgene Corporation violated federal and state antitrust laws by preventing generic competition for Celgene’s drug products THALOMID (thalidomide) Capsules and REVLIMID (lenalidomide) Capsules (see our previous post here).  That case is still pending, with a Motion to Dismiss filed by Celgene (Opposition and Reply briefs are available here and here).

The 17-page FAST Generics Act would amend the FDC Act to add Section 505-2, titled “Competitive Access to Covered Products for Development Purposes.”  Proposed FDC Act § 505-2 would add several provisions, including:

(b) COMPETITIVE ACCESS TO COVERED PRODUCTS AS A CONDITION ON APPROVAL OR LICENSING.—As a condition of approval or licensure, or continuation or renewal of approval or licensure, of a covered product under section 505 of this Act or section 351 of the Public Health Service Act, respectively, the Secretary shall require that the covered product’s license holder not adopt, impose, or enforce any condition relating to the sale, resale, or distribution of the covered product, including any condition adopted, imposed, or enforced as an aspect of a risk evaluation and mitigation strategy approved by the Secretary, that restricts or has the effect of restricting the supply of such covered product to an eligible product developer for development or testing purposes. 

(c) COMPETITIVE ACCESS TO COVERED PRODUCTS OTHER THAN REMS PRODUCTS FOR DEVELOPMENT PURPOSES.—No license holder shall adopt, impose, or enforce any condition relating to the sale, resale, or distribution of a covered product that interferes with or restricts access to reasonable quantities of a covered product by an eligible product developer for development and testing purposes, at commercially reasonable, market-based prices, from the license holder or from any wholesaler or specialty distributor authorized by the license holder to commercially distribute or sell the covered product unless the license holder generally adopts, imposes, or enforces lawful conditions relating to the sale, resale, or distribution of a covered product, with respect to other buyers of the covered product.

(d) COMPETITIVE ACCESS TO REMS PRODUCTSFOR DEVELOPMENT PURPOSES.—

(1) PROHIBITED USE OF REMS TO RESTRICTACCESS.—With respect to a REMS product, no aspect of a risk evaluation and mitigation strategy under section 505–1 shall prohibit or restrict, or be construed or applied to prohibit or restrict, the supply of such REMS product to an eligible product developer for development and testing purposes, at commercially reasonable, market-based prices, from the REMS product’s license holder or from any wholesaler or specialty distributor authorized by the license holder to commercially distribute or sell the REMS product.

(2) SINGLE, SHARED SYSTEM OF ELEMENTS TO ASSURE SAFE USE.—With respect to a REMS product, no license holder shall take any step that impedes—

(A) the prompt development of a single, shared system of elements to assure safe use under section 505–1; or

(B) the entry on commercially reasonable terms of an eligible product developer into a previously approved system of elements to assure safe use.

(e) PROCEDURES FOR OBTAINING ACCESS TO COVERED PRODUCTS.—

(1) COMPETITIVE ACCESS.—Notwithstanding any other provision of law, in the case of an eligible product developer that has an authorization to obtain a covered product in effect . . . , no license holder shall adopt, impose, or enforce any other condition relating to the sale, resale, or distribution of such covered product that interferes with or restricts access to reasonable quantities of the covered product by the eligible product developer for development and testing purposes, at commercially reasonable, market-based prices, from the license holder or from any wholesaler or specialty distributor authorized by the license holder to commercially distribute or sell the covered product, unless the license holder generally adopts, imposes, or enforces lawful conditions relating to the sale, resale, or distribution of a covered product, with respect to other buyers of the covered product.

A violation of a requirement or prohibition in any of the above-proposed sections would be treated, in the case of a REMS product, as a violation of the product’s REMS, and would be a prohibited act under proposed FDC Act § 301(ddd).  Also, an “eligible product developer” (i.e., a person seeking to develop an ANDA, 505(b)(2) application, or a BLA) that has authorization for access to a covered product from FDA and that is aggrieved by a violation of one of the above-proposed sections “by a license holder or any wholesaler or specialty distributor authorized by the license holder to commercially distribute or sell the covered product[,] may sue such license holder for injunctive relief and treble damages (including costs and interest of the kind described in section 4(a) of the Clayton Act (15 U.S.C. 15(a)).”

In addition to laying out the procedures for an interested party to obtain an authorization to procure a covered product, the FAST Generics Act would give FDA the authority to prohibit, limit, or otherwise suspend a transfer of a covered product to an eligible product developer because such transfer would present an imminent hazard to the public health, and would shield NDA and BLA holders from liability for any claim arising out of an eligible product developer’s development or testing activities conducted under proposed FDC Act § 505-2, “including a claim arising out of a failure of the eligible drug developer to follow adequate safeguards to assure safe use of the covered product.”

Finally, the bill would require various reports from FDA and from the FTC on the implementation of proposed FDC Act § 505-2, and would amend FDC Act § 505-1(i)(1)(B) concerning waiver of the single, shared REMS requirement (see our previous post here).  If enacted, the bill would apply to all NDAs and BLAs, regardless of whether or not those applications were approved before, on, or after the date of enactment of the FAST Generics Act. 

By Kurt R. Karst –      

There are mortal sins and there are venial sins.  In the latest guidance documents FDA announced (here and here) earlier this week – a final guidance on ANDA Refuse-to-Receive (“RTR”) standards and a draft guidance on ANDA RTR for lack of proper justification of impurity limits – FDA focuses on the mortal sins of ANDA submission that will generally result in the Office of Generic Drugs (“OGD”) refusing to accept an ANDA for review.  Indeed, the phrase “FDA will refuse-to-receive an ANDA” (followed by or preceded by some example) appears not less than 24 times in FDA’s final ANDA RTR standards guidance. 

Both ANDA RTR guidances were issued on the eve of a September 17th public meeting on implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”).  FDA requested comment at the meeting on the ANDA RTR impurity limits draft guidance and other recent guidances on GDUFA implementation (see our previous posts here, here, and here).  FDA also solicited comment on “GDUFA Implementation Related to Generic Drug Exclusivity” and “GDUFA Implementation and Potential First Generics.”  Although very few comments (see here) were submitted to FDA in response to the Agency’s solitation, we understand that the public meeting was well attended and included statements from an array of generic drug industry stakeholders, including the Generic Pharmaceutical Association (see here and here).  The September 17th public meeting follows a solitication from FDA earlier this year seeking input and suggestions on ways to improve the quality of ANDAs and on how to best communicate those suggestions to the generic drug industry (see our previous post here).  About a dozen comments have been submitted to the docket FDA established for that solicitation.

FDA’s ANDA RTR standards guidance finalizes a draft version of the guidance released in October 2013.  In addition to providing greater clarity around major deficiencies (i.e., mortal sins) that will generally result in an RTR decision and minor deficiencies (i.e., venial sins) that can be easily corrected, the guidance makes several important changes to the draft version.  Bob Pollock from Lachman Consultants covers those changes in his recent post. 

In the ANDA RTR impurity limits draft guidance – a guidance FDA presumably issued in draft form and separate from the ANDA RTR standards guidance because the issue was not addressed in the draft ANDA RTR standards guidance – FDA lays out serious deficiencies in impurity information that could cause FDA to RTR an ANDA. The deficiencies described in the draft guidance include: “(1) Failing to justify proposed limits for specified identified impurities in drug substances and drug products that are above qualification thresholds; (2) failing to justify proposed limits for specified unidentified impurities that are above identification thresholds; and (3) proposing limits for unspecified impurities (e.g., any unknown impurity) above identification thresholds.” 

As Bob Pollock notes, the position FDA takes in the draft guidance “is consistent with past Guidance issued by OGD on the requirements for justification of impurity limits, but, in the past, OGD has not stated that if such justification is lacking, they will issue an RTR letter rather than handling the issue as a review issue.”  This is an important observation, because it shows that OGD is making an effort to clarify the sometimes fuzzy line between what constitutes a deficiency for ANDA RTR purposes, and what is properly an ANDA review issue (and not an RTR issue).  Indeed, we’re likely to see more follow-on, issue-specific guidances like the ANDA RTR impurity limits draft guidance as the new ANDA filing and review groups within OGD hash things out and establish brighter lines between ANDA filing and review issues.  FDA says as much in the notice announcing the ANDA RTR impurity limits draft guidance: “FDA intends to develop additional guidance documents further clarifying the enhanced refusal to receive standards.”

By James E. Valentine* –

On September 10, 2014, the FDA hosted its 3rd Annual Patient Network Meeting, “Under the Microscope: Pediatric Drug Development,” to explore challenges related to pediatric drug development.  The Patient Network is a program run out of FDA’s Office of Health and Constituent Affairs “to bring the unique perspectives of patients, family members, caregivers, and patient advocates to the decision-making processes of the FDA.”

The meeting consisted of a series of educational and interactive panel discussions, which discussed current regulations that encourage pediatric product development, as well as ways to advance pediatric drug development.  While the meeting focused on patients and patient advocates, the discussions also included perspectives from regulators, industry, and academia.

Dr. Lynne Yao, Associate Director of the Pediatric and Maternal Health Staff in FDA’s Center for Drug Evaluation and Research’s Office of New Drugs, and Dr. Dianne Murphy, Director of FDA’s Office of Pediatric Therapeutics, set the stage for further discussion by presenting the historical framework and challenges for pediatric product development.  There was a consensus that the Pediatric Research Equity Act ("PREA") and the Best Pharmaceuticals for Children Act ("BPCA") have helped facilitate the studies to support approved pediatric labeling (see here), and that the permanent reauthorization in FDASIA was a positive step forward. 

Dr. Robert “Skip” Nelson, Deputy Director and Senior Pediatric Ethicist of FDA’s Office of Pediatric Therapeutics, provided an overview of the ethical framework and regulatory protections for children in research, consisting of (1) scientific necessity, (2) appropriate balance of risk and benefit, (3) parental permission, and (4) child assent. 

Throughout the course of the panel discussions, a series of challenges to pediatric product development arose from both the regulatory and industry perspectives.  An underlying problem is that pediatric studies, like studies of orphan drugs, enroll subjects from a small population.  As a result, there are fewer subjects to enroll in studies, and there may be a limited ability to recoup costs of development and formulations. 

Additionally, it is more difficult to conduct pediatric trials due to the need for multicenter and often international studies in order to enroll adequate numbers of patients, as well as the need for special facilities, equipment, nurses, laboratories, and expertise.  Also, studies require many age subsets or subset analyses because pediatrics covers a wide range of organ developmental maturation, which may affect drug pharmacokinetics, efficacy, and safety.  Other challenges include the need for juvenile animal studies, age-appropriate pediatric formulations, and age-appropriate and validated pediatric endpoints and assessment tools.

Some recommendations from patients, regulators, industry, and academia included:

• A need for the entire pediatric community to insist on incorporation of evidence based treatment sufficient to support pediatric labeling;
• Development of simplified pediatric networks to conduct appropriate clinical trials;
• Education of caregivers about the importance of clinical trial enrollment, understanding the role of a control arm, and the option and ramifications of “opting out;”
• The need for flexibility by FDA in the design of pediatric studies, especially to relieve the tension with formulation development; and
• Increased patient and caregiver input in FDA and industry’s planning and decision-making (i.e., caregiver input on protocols, caregiver participation in protocol simulations).

Ultimately, there was accord among the meeting participants that you protect children not from studies but with studies. 

For more information, the full meeting agenda can be found here and the speaker bios and presentations can be found here.

*Not admitted to practice in Washington, D.C.

FDA’s 510(k) review is based upon the concept of substantial equivalence.  This approach has been much criticized, but in a new article published in the Food and Drug Law Journal and authored by Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro, Mr. Shapiro concludes that substantial equivalence review is a powerful regulatory tool allowing FDA to ensure that the broad range of moderate risk devices reach the market based upon a reasonable assurance of safety and effectiveness. 

The article, titled “Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices,” examines substantial equivalence review in detail, looking at its historical development, the operative legal framework, the specific decision steps FDA follows to reach a substantial equivalence determination, and the strengths of the system in fostering efficiency, predictability, and adaptability in the premarket review of medical devices.  The article rebuts the Institute of Medicine’s call to scrap substantial equivalence review (see our previous post here), and rebuts a published study finding that substantial equivalence review results in a disproportionate share of serious recalls.  The article argues that a better public 510(k) database is needed to improve the predictability of substantial equivalence review.  Mr. Shapiro concludes by calling for targeted reform of a basically sound system rather than wholesale condemnation as critics have suggested. 

The integrity of Generally Recognized As Safe (“GRAS”) determinations, and FDA’s reliance on the voluntary GRAS notification process, has come under attack.  Critics allege that, among other things, GRAS determinations employ outdated science; GRAS determinations are rife with conflicts of interest; the safety of food ingredients should be assessed in the same way that pesticides are assessed for safety; GRAS determinations are never re-visited; and the data supporting GRAS determinations are secret.  At the upcoming ISRTP Workshop on GRAS determinations, truly qualified experts will explain the facts and dispel the fictions circulating in the ongoing debate.  Attendees will have ample opportunity to question the experts.  The Workshop will be held on October 13-14, 2014 in Washington, D.C.  Space is limited so rush to register.  A copy of the Workshop agenda and registration information are available here.        

By Larry K. Houck & Andrew J. Hull –

Last week, the Drug Enforcement Administration (“DEA”) published its final rule implementing the Secure and Responsible Drug Disposal Act of 2010 (“Disposal Act”).  79 Fed. Reg. 53,520 (Sept. 9, 2014).  A post appeared here when DEA issued its notice of proposed rulemaking back in December 2012.  DEA considered 192 comments in response to the notice of proposed rulemaking.  The disposal regulations become effective October 9, 2014.

DEA’s final rule significantly expands the options available to ultimate users to dispose of their controlled substances.  Prior to implementation of the final rule, ultimate users (e.g., patients) could only dispose of unused, unwanted and expired controlled substances by destroying the drugs themselves (e.g., by flushing), by surrendering the drugs to law enforcement agencies or by requesting assistance from DEA.  As a result of these limited options, unused controlled substances accumulated in household medicine cabinets, creating a significant risk of diversion or accidental ingestion.  The Disposal Act amended the Controlled Substances Act, requiring DEA to implement regulations permitting ultimate users to deliver the medication to third parties for disposal.  The ultimate goal of the regulation is to decrease unused pharmaceutical controlled substances in households, thereby reducing the risk of diversion and harm.  Some highlights of the new regulation include the following:

Ultimate Users.  The final rule allows ultimate users to continue disposing their unused or outdated controlled substances through previously allowed methods (mentioned above), and creates three other options.  Ultimate users may: (1) drop off the drugs at take-back events overseen by law enforcement agencies; (2) send the drugs to a law enforcement agency or authorized collector operating a mail-back program; or (3) drop the drugs at a collection receptacle maintained by a law enforcement agency or an authorized collector.

Law Enforcement Agencies.  The rule specifically allows law enforcement agencies to conduct take-back and mail-back programs, and maintain collection receptacles at their physical location.

Registrants and Reverse Distributors.  Manufacturers, distributors, reverse distributors, narcotic treatment programs (“NTPs”), hospitals and clinics with on-site pharmacies and retail pharmacies can modify their DEA registrations to become “collectors” (defined as registrants “authorized” to “receive a controlled substance for the purpose of destruction”).  As authorized collectors, they may operate mail-back programs to receive and destroy schedule II-IV controlled substances received from ultimate users.  To operate a mail-back program, they must make packages available to the ultimate user.  Collectors operating mail-back programs must also destroy the drugs onsite.  We anticipate that the on-site destruction requirement will deter many registrants from becoming authorized collectors via a mail-back program.  Authorized collectors permitting take-backs on their premises may install, manage and maintain a collection receptacle for schedule II-IV controlled substances delivered by ultimate users.  Controlled substances collected in this manner may be destroyed onsite or may be transferred to a reverse distributor.  The final rule establishes new recordkeeping and safety requirements for registrants serving as authorized collectors.

Registered NTPs that become authorized collectors may maintain collection receptacles at their registered locations.  The NTPs must maintain the collection receptacles in a securely locked room with limited access that contains no other controlled substances.  Hospitals/clinics with on-site pharmacies, as well as retail pharmacies, that become authorized collectors can also maintain collection receptacles inside their registered locations or at long term care facilities. They may also conduct mail-back programs.

Controlled substances collected through take-back events, mail-back programs and collection receptacles may be comingled with non-controlled substances.  Collectors cannot individually count or inventory the controlled substances they collect through collection receptacles.

DEA has modified  DEA Form-41 (“Registrants Inventory of Drugs Surrendered”), to allow registrants who dispose of controlled substances to account for the destruction of collected controlled substances.

Reverse Distributors. The final rule clarifies the definition of “reverse distribute” and “reverse distributor,” as well as security, inventory and recordkeeping requirements applicable to all entities that reverse distribute controlled substances.  Reverse distributors are now defined as “entities registered with the Administration as [] reverse distributor[s]” (i.e., persons permitted to acquire controlled substances in order to return them to manufacturers or to destroy them). (Specified entities who reverse distribute are not just those registered as reverse distributors).

Destruction.  DEA does not mandate that collectors use a particular destruction method so long as they render the controlled substances “non-retrievable.”  DEA defines “non-retrievable” as “the condition or state…following a process that permanently alters that controlled substance’s physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes.”  Controlled substances rendered non-retrievable are no longer subject to regulation by DEA.

Costs/Benefits.  DEA recognizes that collection and disposal of controlled substances is voluntary and costly.  DEA notes that costs to collectors may be offset by potential benefits of providing these services, including “increased consumer presence” at the registered locations.

Caveats.  Registrants considering voluntarily becoming authorized collectors must be aware of heightened recordkeeping and other responsibilities.  The voluntary nature of authorized collector status does not obviate a registrant’s duty to comply with these heightened requirements, especially because the additional security and recordkeeping requirements relate to preventing diversion.  See, e.g., Fred Samimi, M.D., 79 Fed. Reg. 18,698, 18,709-10 (Apr. 3, 2014). Second, registrants who take on the responsibility of destroying collected controlled substances should proceed with caution as they develop certain destruction methods.  DEA specifically stated that it would not require registrants to use any particular method of destruction.  DEA’s specific standard of “non-retrievable,” as well as its detailed definition of the same, must guide registrants in fulfilling their responsibilities.  Registrants should be wary of not only the cost of destruction but also the risk of developing a method that DEA may later find does not meet DEA’s interpretation of “non-retrievable.”

Final Word.  Registrants contemplating the merits of becoming collectors should consider the benefits to the community and themselves by assuming these additional responsibilities.  The diversion and abuse of unused and outdated controlled substances is a significant problem, and DEA’s development of this disposal program as part of a congressional mandate, has the potential to address this issue.  Registrants should not, however, accept these new, voluntary responsibilities without also considering the additional recordkeeping and security requirements – not to mention costs – associated with them.

By Michelle L. Butler & Kurt R. Karst –

As we recently reported, the U.S. District Court for the District of Columbia granted Depomed Inc.’s ("Depomed’s") Motion for Summary Judgment and ordered FDA to recognize orphan drug exclusivity for Gralise (gabapentin) Tablets “without requiring any proof of clinical superiority or imposing any additional conditions on Depomed.”  The court’s Memorandum Opinion is now available.  This decision, which finds that “the plain language of the exclusivity provisions of the Orphan Drug Act requires the FDA to recognize exclusivity for any drug that the FDA has designated and granting marketing approval,” Mem. Op. at 33 (emphasis added), has far-reaching implications for FDA’s orphan drug program (and perhaps beyond).

The facts of the case are discussed in our previous posts (here and here).  The court, in its September 5th opinion, decided the case on Chevron Step 1 grounds, which means that the court determined that “the plain language of the Orphan Drug Act requires the FDA to recognize exclusivity for Gralise.”  Id. at 18.  The court stated that the statute

employs the familiar and readily diagrammable formula, ‘if x and y, then z.’  Congress has crafted its command to the Secretary of the FDA in a manner that sets forth two circumstances – a drug that has been designated for a rare disease or condition, and the FDA’s approval of a marketing application for that drug – that, if present, result in a particular consequence: a seven-year period of abstinence regarding marketing approval for other such drugs.

Id. at 20.  Importantly, the court described the orphan drug exclusivity incentive not as a benefit conveyed to manufacturers, but rather as “a restriction of the FDA’s ability to approve the marketing of other such drugs for the same rare disease or condition (referred to herein as ‘new such drugs’) when a drug that has been designated as an orphan drug is approved for marketing.”  Id.  The court asserted that the statute “does not permit or invite discretion on the part of the FDA regarding whether or not to continue authorizing new such drug marketing applications once an orphan drug has been so designated and approved,” citing the fact that the statute specifically identifies only two exceptions to the grant of exclusivity.  Id. at 21 (citing 21 U.S.C. § 360cc(b), which provides exceptions if the manufacturer of a drug with marketing exclusivity cannot assure availability of the drug or provides written consent for approval of other applications).

The court rejected FDA’s arguments that the statute was ambiguous under the circumstances presented, and, therefore, permitted FDA to impose its clinical superiority requirements.  Id. at 22-26.  Among other things, the court stated that

[t]ry as they might, Defendants cannot square their insistence that the FDA has the discretion to address this situation with the fact that, under the statute, Congress did not give the FDA any discretionary authority to grant or deny exclusivity at all – rather, as mentioned previously, Congress forbade the FDA from granting any further approvals when the statutory conditions were met.

Id. at 25.  The court also stated that the structure of the statute “suggests that the intent of Congress was to provide the FDA with a merely ministerial role in the exclusivity process” and operated “by removing FDA discretion to approve the marketing of certain other drugs.”  Id. (emphasis in original).

The court also rejected FDA’s policy arguments that giving effect to the plain language of the statute would lead to an absurd result.  FDA argued that (1) affirming exclusivity for Gralise could permit Depomed to cut off new gabapentin entrants to the market without providing any benefit in the treatment of post-herpetic neuralgia ("PHN") and (2) such an interpretation could result in serial exclusivity for the same drug.  Id. at 27.  The court rejected both arguments.  As to FDA’s first policy argument, the court commented

This policy argument misses the mark by a mile.  To the extent that Defendants’ contention is that Congress never would have intended for a “me too” drug like Gralise to get a benefit that the legislature devised to entice new entrants into the rare-disease treatment market, Defendants’ point is unfounded—nothing in the statute even remotely suggests that Congress intended to incentivize only one sponsor to produce a particular drug (although Congress certainly could have specified as much), and general market forces provide a plausible reason for a legislative scheme that deliberately incentivizes multiple manufacturers of the same pharmaceutical product.  Nor can it be said that permitting Depomed to grasp the brass ring of exclusivity for Gralise is unfair to the manufacturers of the prior iterations of the drug, since each had every opportunity to seek exclusivity and failed to do so.  If, on the other hand, Defendants are making the . . . argument that it would be ‘absurd’ for the same drug as others already on the market to be permitted to cut off the development of new and improved versions, that result appears to be a function of granting a drug marketing exclusivity in any event – i.e., the statute plainly incentivizes investment in drugs for rare disease and conditions precisely because it prevents new (and potentially better) drugs from being adopted and marketed for that same condition – and this is inherent in the exclusivity statute. 

Id. at 29 (emphasis in original).  As to FDA’s second policy argument, that also fell flat with the court:

The second potentially absurd result that Defendants identify is a variation on this same theme—and fails for the opposite reason. . . .  As far as this Court can tell, Defendants are worried that interpreting the statute to mandate exclusivity whenever a drug has obtained designation and approval could lead to a situation in which sponsors that have exclusivity for a particular drug could simply tweak their formulation for that drug and resubmit applications for designation and approval after the initial exclusivity period has expired, thereby gaining successive exclusivity periods. . . .  However, under the statutory scheme as it currently exists, this result would only occur if the FDA permitted it to happen.

Id. at 30 (emphasis in original). 

Taken together, the court’s statements about the effect of exclusive approval could potentially be read to put in jeopardy FDA’s “same drug” regulations, which permit FDA to ignore a previously approved drug’s exclusivity in order to approve a “clinically superior” drug with the same active moiety that will be marketed for the treatment of the same orphan disease.  The court does not explicitly reach this conclusion, but some of the court’s statements about Congressional intent in providing for exclusivity and FDA’s lack of discretion with regard to matters of exclusivity could be read to suggest that, once exclusivity is granted, other drugs with the same active moiety for the same orphan indication cannot be approved during that period of exclusivity.  On the other hand, the court’s statements are generally in the context of whether FDA can decline to grant exclusivity in the first place as opposed to whether the exclusivity, once granted, is inviolable.

Interestingly, the court also notes that

as luck would have it for the FDA, the agency has the ability and the opportunity to control the circumstances under which marketing exclusivity attaches because the FDA is responsible for determining when to designate a drug as an orphan drug under section 360bb, and it is also the agency that has the duty of deciding when and under what circumstances a drug will be approved for marketing.

Id. at 21.  The court seems to be suggesting that, if FDA is unhappy with this turn of events, it can affect whether a drug ultimately obtains exclusivity by applying a stricter standard at the designation step.  Indeed, the court later states that “FDA could require designation applicants to show clinical superiority before granting their product orphan-drug designation. . . .”  Id. at 30. 

There are many initial questions raised by this decision, and there are likely more that will arise as we continue to think through the implications.  Here’s a short list of some of our initial questions:

• Will FDA appeal the decision?  What will the Agency do in the meantime – perhaps seek a stay of the decision?
• What effect will the decision have on pending ANDAs for gabapentin (citing Neurontin as the reference listed drug) that currently include the PHN indication, as well as ANDAs for generic Neurontin approved after the January 28, 2011 approval of Gralise?  Language in the opinion about the scope of exclusive approval suggests that FDA cannot approve any applications (including ANDAs) that contain the same active ingredient (gabapentin) as Gralise for the orphan indication during the period of orphan drug exclusivity.  Would the sponsors of those pending ANDAs need to now “carve out” the PHN indication?
• What effect will the decision have on other drugs with orphan drug designations that obtained approval but were unable to obtain orphan drug exclusivity due to an inability to demonstrate clinical superiority?  Will FDA now grant exclusivity to those drugs?
• What effect will the decision have on FDA’s ability to approve a second drug during a period of orphan drug exclusivity on the basis that the second drug is not “such drug” as the approved drug (i.e., is not the “same drug” under FDA’s regulations) on the basis that it is clinically superior to the approved drug? 
• What effect will the decision have on FDA’s designation process?  Will FDA impose a higher bar at the designation step for drugs that are claimed to be clinically superior?  How can a higher bar to designation be squared with other benefits under the Orphan Drug Act (e.g., tax credits)?  
• What effect will the decision have on FDA’s orphan drug regulations?  If FDA accedes to the court’s reasoning, the current regulations, at least with respect to FDA’s recognition of exclusive approval at 21 C.F.R. § 316.34(c), would need to be revised.  Would FDA take a new look at the clinical superiority requirements more broadly?

By Jennifer D. Newberger –

On August 19, 2014, FDA finalized its guidance document, “FDA Decisions for Investigational Device Exemption Clinical Investigations,” which was issued in draft in June 2013.  The final guidance is largely similar to the draft, with the exception of the pre-decisional IDE process.  As we noted in our blog post on the draft guidance, it was not clear how the pre-decisional IDE process would actually benefit sponsors, since the timeframe for review was essentially the same as without the process. 

In the Federal Register notice announcing the draft guidance, FDA specifically sought feedback on the utility of the pre-decisional process.  In its notice announcing the final guidance, FDA stated:  “Some commenters expressed support for the proposal and felt that it might shorten the time to full approval of pivotal IDE studies. Other commenters expressed concern that the Pre-Decisional IDE process itself might be too time-consuming or require extensive FDA resources that could be better allocated elsewhere. Based on the comments received and FDA’s consideration of the points raised, FDA will not pursue the Pre-Decisional IDE at the present time.”  79 Fed. Reg. 49089, 49090 (Aug. 19, 2014). 

There are two other changes that relate to how information will be conveyed by FDA to the IDE sponsor.  In both the draft and final guidance, FDA states that, if it “identifies concerns unrelated to subject safety which the Agency believes should be addressed to enable the study to support the sponsor’s stated goals (e.g., a future marketing application or future study), FDA intends to communicate these ‘study design considerations’ [SDCs] to the sponsor.” 

In the draft guidance, FDA proposed that these SDCs be included in a section of the IDE decision letter.  In the Federal Register notice announcing the final guidance—but not in the final guidance itself—FDA states that it will provide the SDCs in a separate attachment included with the IDE decision letter.  It is doing so because it “believes that sponsors and other stakeholders may misinterpret SDCs included in the body of a decision letter as issues that are required to be addressed.”  The SDC letter will state:  “These recommendations do not relate to the safety, rights or welfare of study subjects, and they do not need to be addressed in order for you to conduct your study.’’ Id.

FDA also intends to convey “future considerations” in a separate letter.  “Future considerations” are “issues or recommendations that FDA believes the sponsor should consider in preparing for a marketing application or a future clinical investigation but which FDA does not deem necessary to address to enable the current study to support its stated goals.”

One thing that unfortunately did not change from the draft guidance is the language FDA uses with respect to the study design assessment.  The final guidance states that FDA’s decision letter will specify whether FDA believes that “the study design is adequate and may support a future marketing approval or clearance, if it is successfully executed and meets its stated endpoints without raising unforeseen safety concerns.”  Guidance, at 12 (emphasis added).  It is not clear why FDA cannot say that if the study design is adequate, it will support a future marketing approval or clearance, if it meets its endpoints and does not raise unforeseen safety concerns.  The statement about the endpoints and safety concerns is not even the entire caveat FDA provides; the guidance also states that “FDA intends to consider changes to its assessment of the study design only if the sponsor materially changes the device or the study design or important issues relevant to a determination of safety or effectiveness have emerged since it approved the IDE.”  FDA therefore seems to have given itself sufficient “outs” and should be willing to state “will” rather than “may.”  Also, it is interesting to note that FDA only “intends” to change its assessment if certain circumstances arise; it will not commit to only changing its position in those circumstances.  Given all of the qualifying language with respect to a statement that a study design is adequate, FDA is not guaranteeing that a successful study will yield a clearance or approval.  On the other hand, FDA should need to shoulder a high burden to justify changing its views.

By Jennifer M. Thomas & Anne K. Walsh –

French device maker PREVOR won another victory against FDA in litigation involving FDA’s interpretation of the statutory definition for “device.”  The first suit, as readers may recall (see our previous post here), resulted in a finding from District Court Judge Rosemary Collyer that FDA had acted arbitrarily and capriciously in classifying PREVOR’s Diphoterine® Skin Wash (“DSW”) as a combination product to be regulated as a drug.  The Court flatly rejected FDA’s interpretation of the “device” definition, and remanded the matter to FDA to make a new determination in compliance with her opinion.  In its subsequent decision, however, FDA boldly rejected the Court, the law, and FDA precedent, when it introduced a wholly new standard for interpreting the “device” definition (“meaningfully contributes”). So Prevor sued FDA again (see our previous post here).

In the September 9, 2014 opinion, Judge Collyer rightfully rejected FDA’s second attempt to evade the plain statutory language with a novel standard.  She adopted PREVOR’s plain meaning of “achieves,” and rejected FDA’s contention that “meaningfully contributes” is synonymous with “achieves.”  The Court also provided an evaluation of the context and legislative history of the “device” definition to support its decision.  Importantly, Judge Collyer found that “[t]he statute does not demand that FDA quantify the exact contribution of a product’s ultimate goal [in order to classify it as a drug].  However, it does require more than simply finding that the product would not work as claimed without chemical action.”  Slip Op. at 19 n. 7.

In its 23-page opinion, the Court rejected FDA’s decision and its reasoning as being “based on an erroneous and unreasonable interpretation of the law,” and remanded the case to FDA “to determine a standard that complies with the statutory requirements and to classify DSW accordingly.”  We do not know whether FDA will accept the Court’s ruling, but if so, we believe the right result is that FDA should regulate DSW as a device.

Hyman, Phelps & McNamara, P.C. (attorneys Jeffrey N. Gibbs, John R. Fleder, Anne K. Walsh, and Jennifer M. Thomas) represent PREVOR.  Amici curiae in the case include Alcoa, United Steel Workers of America, and the Washington Legal Foundation.