By James P. Ellison –

Despite the Supreme Court’s 2008 ruling in Riegel v. Medtronic, in which the Court found express preemption for devices subject to premarket approval based on express statutory language, the judge in Minnesota overseeing multi-district device litigation granted the plaintiffs’ motion to amend their complaint to comply with the Court’s recent ruling in Wyeth v. Levine.  The judge’s order is significant because just two months ago this same judge granted a motion to dismiss the claims in those device cases based on preemption.

While it is not clear that the judge overseeing these cases believes that Wyeth affects Riegel and device preemption, the order provides tangible evidence that even if none of the pending bills (here and here) to undo device preemption (which seem to have been motivated by Wyeth) become law, Wyeth may nevertheless have implications for device litigation.

By Kurt R. Karst –      

Earlier this week, FDA announced that the Agency will reverse course and grant Amyotrophic Lateral Sclerosis (“ALS”) patients “compassionate use” access to IPLEX (mecasermin rinfabate [rDNA origin] injection).  FDC Act § 561, which was added to the statute in 1997 by the FDA Modernization Act, identifies the criteria for determining whether an individual patient should have access to an investigational drug for treatment use – that is, a single-patient IND.  FDA approved IPLEX in December 2005 for the treatment of growth failure in children with severe primary IGF-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone; however, Insmed Inc., which holds the IPLEX NDA, discontinued marketing the drug as the result of a patent infringement settlement. 

FDA’s decision to grant ALS patients access to IPLEX comes on the heels of a series of letters issued in January 2009 in which the Agency claimed that there was insufficient evidence of the safety and efficacy of IPLEX in treating ALS patients.  The Washington Legal Foundation (“WLF”) announced earlier this month that it had appealed (here and here) those decisions, and “pledged to pursue relief in the courts if its appeals are denied.” 

According to FDA’s announcement, “[a]s FDA continued to receive requests for access to Iplex after the initial denials of the single-patient INDs, we continued to evaluate the data and pursued several actions in parallel,” and “the data were useful in that no serious, immediate drug-related toxicities were apparent.”  Under an agreement between FDA and Insmed, access to IPLEX for investigational use in ALS patients will occur in two ways under INDs: 

1. Single-patient INDs requesting “compassionate use” of Iplex for treatment of named patients with ALS, received and date-stamped by FDA’s document room by close of business on March 6, 2009, will be allowed to proceed, and Insmed has agreed to supply Iplex to those patients; and

2. The remaining supply of Iplex, which is very limited, will be used by Insmed to conduct a clinical trial under an IND in which other patients with ALS who are interested in receiving Iplex treatment will be randomly assigned to receive drug through a lottery system.

According to a WLF press release, “[a]lthough FDA did not explain how it would conduct its lottery for ALS patients who have not yet filed Treatment INDs, the system appears to be designed to ensure that FDA can obtain meaningful data regarding Iplex’s safety and effectiveness.”

By Kurt R. Karst –      

Earlier today, Representative Henry Waxman (D-CA) (along with Representatives Nathan Deal (R-GA), Frank Pallone (D-NJ), and Jo Ann Emerson (R-MO)) announced the introduction of H.R. 1427, the Promoting Innovation and Access to Life-Saving Medicine Act, which authorizes FDA to approve abbreviated applications for so-called “biosimilar” and “biogeneric” biological products.  According to the bill, “biosimilar” products are comparable to the innovator product and “biogenerics” are therapeutically interchangeable with the innovator.  Rep. Waxman introduced another bill in the 110th Congress with a similar name (H.R. 1038 – the Access to Life-Saving Medicine Act); however, that version did not provide for any period of market exclusivity for innovator products – only a period of 180-day exclusivity for the first interchangeable biological product. 

Under the new version of the bill, which adds “Promoting Innovation” to its title, an original product with a novel molecular structure would be entitled to 5 years of market exclusivity, and a modification of a previously approved product would be entitled to 3 years of market exclusivity.  This exclusivity scheme is similar to the current regime for drug products approved under the FDC Act and created by the Hatch-Waxman Amendments – a model that Boston University Economics Professor Laurence J. Kotlikoff suggested be used in a 2008 paper.  The 5- and 3-year periods under the Waxman bill could be extended by up to 1 year if the applicant establishes that the product can be used for a new disease indication or conducts pediatric studies.  However, market exclusivity would be reduced by 3 months for a “blockbuster” product (i.e., combined U.S. annual gross sales exceeding $1 billion). 

The bill would also provide for a period of first biogeneric exclusivity.  Specifically, the first biogeneric applicant to demonstrate interchangeability with a reference product would receive a period of 180-day market exclusivity during which FDA could not approve another generic interchangeable product, as well as an authorized generic version of the innovator’s product (termed as a “rebranded interchangeable biological product” in the bill).  Under the bill, a product found to be interchangeable could be safely substituted for the original product (if such substitution is permitted by state law). 

As with several other follow-on biologic bills introduced in the 110th Congress, Rep. Waxman’s bill would establish a complex patent resolution procedure.  Under the new bill, patent disputes can be resolved before a biosimilar product is approved.  In addition, the bill would create penalties for failure to litigate patents in a timely fashion. 

Under the Waxman bill, FDA would have full scientific discretion to determine what studies – including clinical studies – are necessary to establish that a biosimilar product is as safe and effective as the original product, and that a biogeneric is interchangeable with the original product. 

Rep. Waxman’s bill is the first follow-on biologics bill introduced in the 111th Congress.  It seems likely that other bills will follow, including perhaps a new bill from Reps. Anna Eshoo (D-CA) and Joe Barton (R-TX), who, as we previously reported, introduced the Pathway for Biosimilars Act last year.  That bill provided for a substantially longer period of innovator market exclusivity. 

By James P. Ellison –

The relationship between the federal government and qui tam relators is defined in part by statute and case law, but that law does not fully capture the often complex and varying relationship between qui tam relators and the government on whose behalf they bring suit. 

Relationship on the Rocks:  The March 6, 2009 announcement from the U.S. Attorney’s Office for the Southern District of New York that, the day before, it had achieved  closure on a settlement it had reached with a defendant in the fall of 2007 showed that  sometimes the government relator relationship can be a rocky one.

According to the release, the government had agreed to terms with Weill Medical College of Cornell University over a year ago, but the relator who initiated the lawsuit objected to the settlement, and challenged it in court.  That challenge was denied by Judge William H. Pauley on March 5, 2009, allowing the settlement to move forward.  Under the terms of the settlement Weill Medical College will pay $2.6M to settle civil fraud charges arising out of federal grant applications.  The government alleged that the principal investigator for those grants failed to disclose the full extent of her research activities (which according to the government exceeded 100% of her available time). 

Indeed, the government can even dismiss a qui tam case over the objection of a Relator.  In Hoyte v. American National Red Cross, the Department of Justice successfully moved to dismiss a qui tam case, over the strenuous objection of the Relator.  On March 4, 2008, the D.C. Circuit ruled that the Justice Department has virtually unfettered discretion to dismiss a qui tam action, even if the government has not intervened in the case.  (Hyman, Phelps & McNamara, P.C. represented the defendant in the case.)

Lending a Helping Hand: The February 25, 2009 announcement out of Main Justice announcing the unsealing of suit against Forest Laboratories for alleged off-label promotions and ant-kickback violations shows how the government can help.

Not only did the government intervene in two existing qui tam lawsuits, but it filed its own Complaint in Intervention.  We have previously noted (here and here) that a number of courts have imposed stricter pleading requirements on relators who bring off-label cases.

Frequently, the relator (often a former sales employee) does not have access to claims data (which would be in the possession of the physician or other practitioner who submitted the claim for reimbursement to a federal healthcare program).  In contrast, the government has that information, and apparently can put it into easy to read charts, thus making challenges to the specificity of fraud allegations considerably more difficult. 

Too Early toTell: Lastly, while the February 19, 2009 press release out of the U.S. Attorney’s Office for the Northern District of California announcing the government's intervention in another off-label case is seemingly a statistically bad sign for defendants, Scios Inc. and Johnson & Johnson (according to 2008 statistics, 98.5% of the money recovered last year was in cases in which the U.S. intervened), it is not clear what this means for the government relator relationship.  The press release notes that: “The qui tam or whistleblower actions contain additional allegations.  However, the United States is only intervening with regard to allegations that Scios marketed the drug Natrecor for serial infusions in outpatient setting.”  On one hand, the relators may be pleased that they have the government’s help on those particular allegations.  On the other hand, if – down the road – the the government seeks to settle the case without giving value to the relator-only allegations, things could get complicated.

By Ricardo Carvajal –      

The USDA Animal and Plant Health Inspection Service (“APHIS”) plans to hold public meetings in the Washington D.C. area in April to address issues raised by its proposal to revise its regulations on the importation, interstate movement, and environmental release of genetically engineered organisms.  In a previous Federal Register notice (74 Fed. Reg. 2907), APHIS requested comment on the following four issues:

(1) Scope of the regulation and which [Genetically Engineered (“GE”)]  organisms should be regulated;
(2) Incorporation into APHIS regulations of the Plant Protection Act’s noxious weed authority;
(3) Elimination of notification procedure and revision of the permit procedure;
(4) Environmental release permit categories and regulation of GE crops that produce pharmaceutical and industrial compounds.

These four issues will be included in the agenda for the April public meetings.  The dates of those meetings have yet to be announced.  However, APHIS has announced a scoping session scheduled for March 13 to consider recommendations for additional issues to include in the agenda for the April public meetings.  According to a prepublication copy of the Federal Register notice announcing the scoping session, APHIS will also welcome recommendations for what meeting format to use so as to “best ensure agenda issues will be frankly and fully explored.”  In addition, APHIS is extending the comment period for the proposed rule until 60 days after the April meetings (the current comment period would have closed on March 17).  Transcripts of the scoping session and the public meetings will be part of the administrative record for the proposed rule.

By Ricardo Carvajal –      

In response to the recent outbreak of Salmonella in peanut-derived products, FDA has issued a Guidance for Industry targeted to manufacturers who use peanut-derived ingredients in their products. (The guidance does not target producers of those ingredients.)  The guidance addresses different factors that can impact the effectiveness of Salmonella control measures, and recommends steps to ensure that the presence of Salmonella is adequately reduced in finished products.  FDA observes that “[d]etermining the processing conditions appropriate to adequately reduce Salmonella spp. in a particular food product involves considerable expertise in both food microbiology and the physics of heat transfer.”  In addition, the guidance warns that “[a] history of negative microbiological tests for Salmonella spp. in the finished product, while useful in a verification program for a process, is not sufficient, by itself, to determine the adequacy of a process in reducing the presence of Salmonella.”  The guidance also describes as potentially useful a document on the control of Salmonella recently published by the Grocery Manufacturers Association, although FDA disclaims any responsibility for the content of that document.

FDA also discusses different factors that can impact the effectiveness of Salmonella control measures in a bulletin issued to retail food service establishments and food stores.  The bulletin explicitly advises that “any peanut-derived products recalled by a manufacturer should not be used and should be returned or discarded.”

By Ricardo Carvajal –      

FDA has announced a collaboration with the Alliance for NanoHealth ("ANH") that will aim to “expand knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that might mitigate the risks associated with nanoengineered products.”  The Houston-based ANH [www.nanohealthalliance.org] describes itself as “the first multi-disciplinary, multi-institutional collaborative research endeavor aimed solely at using nanotechnology to bridge the gaps between medicine, biology, materials science, computer technology and public policy.”   ANH members include the Baylor College of Medicine, The University of Texas M.D. Anderson Cancer Center, Rice University, the University of Houston, The University of Texas Health Science Center at Houston, Texas A&M Health Science Center, University of Texas Medical Branch and The Methodist Hospital Research Institute.  FDA cites its collaboration with ANH as an example of FDA’s Critical Path Initiative, which was begun in 2004 with the goal of facilitating development of innovative medical products. 

By John R. Fleder & Kurt R. Karst –

Last week, the United States District Court for the Eastern District of Pennsylvania entered a Consent Decree against giant home shopping retailer QVC, Inc.  The Consent Decree stems from a June 14, 2000 Federal Trade Commission (“FTC”) decision and order in which the Commission ordered QVC to cease representing certain products in violation of the FTC Act.  This led to a March 2004 court complaint filed by the Department of Justice against QVC alleging that the company violated the June 2000 order by making false or unsubstantiated claims for several weight-loss products.  The 2009 Consent Decree slaps QVC with a civil monetary penalty of $1.5 million and consumer redress of $6.0 million.  In addition, the Consent Decree modifies the June 2000 order to add additional weight loss products.  Additional information on the FTC’s QVC docket is available here.

By Riëtte van Laack –      

The U.S. Government Accountability Office ("GAO") has released a report that calls for FDA to take further actions to improve oversight and consumer understanding of dietary supplements. In its 2009 Report, GAO reviews developments since its previous report in 2000.  Significant developments are FDA’s actions concerning reporting of adverse events for dietary supplements and issuance of the Current Good Manufacturing Practice regulations for dietary supplements. Nevertheless, GAO remains concerned about FDA’s oversight of dietary supplements.  It concludes that FDA needs more resources and authority to regulate dietary supplements to address safety concerns.

In the report, GAO recommends that FDA request additional authority to oversee dietary supplements, issue the long overdue guidance on new dietary ingredients, clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements.  To enable greater oversight of the dietary supplement industry, GAO recommends that dietary supplement establishments be required to identify themselves as such when registering pursuant to the existing registration requirements under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.  In addition, dietary supplement companies should be required to annually submit a list of all dietary supplements and labels for the products they market.  GAO further recommends that the requirements for reporting adverse events be expanded to include minor adverse events.  However, as FDA pointed out in its comments to GAO’s recommendations, this expansion might backfire; the huge increase in adverse event reports might hinder finding meaningful signals amidst the noise.

In its report, GAO also expressed concerns regarding conventional foods containing dietary ingredients, such as energy drinks.  Specifically, GAO expressed concerns that the dietary ingredients may not be generally recognized as safe.  However, “FDA officials told [GAO] that the current regulatory framework is sufficient to identify and act on safety concerns regarding” such products.  GAO did not make recommendations specifically addressing functional foods.

By Ricardo Carvajal – 

The Food and Nutrition Board of the Institute of Medicine and the Board on Agriculture and Natural Resources of the National Research Council have established an ad hoc committee to examine FDA’s oversight of food safety and make recommendations to fill “gaps in public health protection.”  The committee plans to evaluate FDA’s Food Protection Plan in the context of prior IOM and Government Accountability Office reports, and issue its report in February 2010.  The report is expected to include recommendations for new regulatory and statutory authorities.  The next public meeting of the committee is scheduled for March 24. 

By David B. Clissold –

It seems likely that the answer will be “yes.”  The Family Smoking Prevention and Tobacco Control Act (H.R. 1256) is on a fast-track under the new administration.  The bill passed the House Energy and Commerce Committee by an overwhelming margin on March 4, 2009, two days after it was introduced by Representative Henry Waxman (D-CA).  It is now headed to the full House of Representatives.  The bill is very similar to legislation introduced last year by Mr. Waxman, which stalled in the Senate.

The bill would give FDA the authority to regulate tobacco products, including cigarettes and smokeless tobacco.  The bill mimics portions of the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which currently regulates food, drugs and medical devices, and thus includes concepts that will be familiar to those who interact with FDA on a daily basis.  However, most elements of the new law may seem like a foreign language to those in the tobacco industry, particularly many small businesses.  The bill adopts the general structure of the FDC Act by first defining a tobacco product, and then describing the conditions that would cause a tobacco product to be “adulterated” or “misbranded.”  Adulteration and misbranding charges traditionally form the basis of FDA enforcement action against the food, drug and medical device industries.  As with some foods, the bill provides a “standard of identity” for cigarettes that would, among other things, prohibit the addition of an herb or spice such as strawberry, clove, cinnamon, or vanilla, although “menthol” is specifically permitted.  Other tobacco products could be subject to a standard of identity to be established by FDA.  As with drug, device, and food manufacturers, manufacturers of tobacco products would also be subject to certain registration requirements for manufacturing and processing facilities, and would be required to identify the products handled at each facility.  All registered facilities would be subject to FDA inspection at least every two years. 

Manufacturers would be required to submit to FDA a list of ingredients in every brand of cigarette.  If requested by FDA, manufacturers would be required to submit “any and all documents” relating to research activities for tobacco products, ingredients, components, and additives, including marketing research and underlying financial information. 

The bill would “freeze” the world of tobacco products as it existed on February 15, 2007.  Any tobacco product that was not marketed before that date would be a “new” tobacco product.  In order to market a “new” tobacco product, a manufacturer would have to obtain premarket approval from FDA via an application containing full reports of all information concerning the health risks of the new product.  Alternatively, a manufacturer would have to show that the “new” product was “substantially equivalent” to a tobacco product marketed before that date.  At any time, FDA could refer the application to a Tobacco Products Scientific Advisory Committee.

Labeling requirements for cigarettes and smokeless tobacco, particularly required Warning statements, would be controlled by FDA.  Although already subject to enforcement by the Federal Trade Commission ("FTC"), certain retail establishments would also be brought under FDA jurisdiction, particularly with respect to advertising restrictions.  Under the bill, FDA and FTC would “coordinate” their enforcement and advertising powers.  FDA would issue new regulations regarding the sale, distribution, advertising and promotion of tobacco products.  Retailers in violation of such regulations would be subject to civil penalties (0-$250 for a first offense depending on whether the retailer has an “approved training program,” and up to $10,000 for a sixth violation within a 48-month period).  The bill would authorize FDA to collect “user fees” (a new tax) from manufacturers, although the government’s current authority to tax cigarettes apparently remains unchanged.  With respect to product liability, the bill expressly does not affect the law of any State.

Of the many bills proposed over the last few weeks affecting FDA, (check our FDA Legislation Tracker), this one seems to have a very high priority in the administration and the full support of public health groups.  Some “fine tuning” is likely to result when the measure is considered by the Senate, but we predict that the general structure is likely to survive.  WARNING: FDA may be hazardous to the health of tobacco product manufacturers and retailers.

When Hyman, Phelps & McNamara, P.C. launched the FDA Law Blog 2 years ago today – Is that 14 in “blog years”?  It certainly seems like it, if not more! – we could hardly imagine how successful it would become and how our subscribers (and the Food and Drug Bar generally) would come to rely on it for timely information and insightful commentary on myriad FDA-related issues.  In 2007, blogs were just beginning to be recognized as a vibrant and dynamic medium for conveying thoughts and ideas on a given topic.  Today, there are millions of blogs in the blogosphere covering just about any topic imaginable. 

During our lifetime, we have made over 450 posts, have garnered thousands of subscribers from around the world, and have been recognized as one of the top blogs covering the life sciences – and certainly the best (we believe) blog covering FDA.  In the past year, we have added useful new functions to the blog, including the FDC Act § 505(q) Citizen Petition Tracker and the FDA Legislation Tracker.  And yesterday, we introduced the Risk Evaluation and Mitigation Strategy (REMS) Tracker. 

We thank our subscribers for their continued interest in the blog, and our Hyman, Phelps & McNamara, P.C. colleagues for their time and dedication to writing interesting and informative posts.  Onward to another year of “covering topics of interest to FDA-regulated companies, fellow food and drug and healthcare lawyers and regulatory personnel, as well as people just generally interested in FDA law,” as we first promised.

By Cassandra A. Soltis –      

The Indiana Senate is currently reviewing House Bill No. 1207, passed by the House on February 25, 2009, which would require food establishments having 20 or more locations in Indiana to post both calorie and carbohydrate information “in a manner that allows consumers to consider the information when selecting an item or unit of food.”  H.B. 1207, 116th Gen. Assem., Reg. Sess. (Ind. 2009).  The bill would also require such establishments to make available to customers the amount of calories, fat, saturated fat, trans fat, cholesterol, sodium, carbohydrates, fiber, sugars, and protein in each food item.  In contrast, New York City’s ("NYC’s") menu labeling regulation requires only that calorie information be placed on all menu boards and similar displays.  In addition, NYC’s regulation covers restaurants with 15 or more establishments nationally.

Although some restaurants claim to provide nutrition information voluntarily at the point of purchase or when requested by consumers, many restaurants fail to have such information available, as the movie “Super Size Me” revealed.  NYC’s regulation and Indiana’s bill, if passed, have penalties for food establishments that do not comply with the nutrition information requirements.  (NYC can assess fines between $200 and $2,000; Indiana’s bill proposes a penalty of up to $1,000 for each violation per day.)   

If House Bill 1207 is passed, any challenge to the law would have to consider the outcome of New York State Restaurant Association v. New York City Board of Health, No. 08-1892-cv, 2009 U.S. App. LEXIS 2905 (2nd Cir. 2009), which, as we previously reported, upheld the NYC regulation to challenges on both federal preemption and First Amendment grounds.  Specifically, the court found that the Nutrition Labeling and Education Act of 1990 does not expressly preempt NYC’s regulation, and that the purpose of the regulation – to help address the obesity epidemic and its concomitant diseases – and the means used to achieve that purpose were reasonable.  

According to the Centers for Disease Control and Prevention ("CDC"), Indiana’s obesity rate for 2007 was 26.8%.  It is one of 30 states that had an obesity rate greater than 25%, with Alabama, Mississippi, and Tennessee having a prevalence of obesity equal to or greater than 30%.  Visit the CDC’s website here to view slides that show a significant increase in obesity rates since 1985.

By William T. Koustas –

As we have previously reported, Title IX of the Food and Drug Administration Amendments Act of 2007 (“FDAAA” or “the Act”) provides a new statutory framework and authority for FDA (or “the Agency”) to require Risk Evaluation and Mitigation Strategy (“REMS”) for drugs and biologics.  Specifically, FDAAA permits FDA to require the applicant of a New Drug Application, Biologics License Application, Abbreviated New Drug Application or a supplement thereof to submit a proposed REMS as part of the application prior to approval if the Agency determines that it is “necessary to ensure that the benefits of the drug outweigh the risks of the drug.”   FDC Act § 505-1(a)(1).  The Agency may also require REMS after a product’s approval if FDA “becomes aware of new safety information that makes a determination that such is necessary to ensure that the benefits of the drug outweigh the risks of the drug.”  Id. § 505-1(a)(2).  Further, FDAAA states that drugs and biologics approved prior to the effective date of the Act are “deemed to have in effect an approved risk evaluation and mitigation strategy under section 505-1 of the [FDC Act]…if [they] are in effect on the effective date of this Act elements to assure safe use (A) required under [21 C.F.R. §§ 314.520 or 601.42]; or otherwise agreed to by the applicant and [FDA].”  FDAAA § 909(b)(1).  FDA listed those products in a March 27, 2008, Federal Register notice. 

Since Title IX of FDAAA went into effect on March 25, 2008, FDA has required both new and previously approved drugs to develop REMS consisting of one or more elements provided for in the FDAAA provisions.  Those elements include a medication guide or patient package insert, a communication plan to healthcare providers, and elements to assure safe use (e.g., a restrictive distribution program).  FDC Act § 505-1(e).  Additionally, all REMS must include a timetable for assessments with assessments at 18 months, 3 years and 7 years after approval of the REMS.  Id. § 505-1(d).

Because the number of approved and requested REMS continues to grow and class-wide REMS begin to emerge (see FDA’s announcements regarding opioids and TNF blockers), we decided to provide a means by which to track those REMS approved by FDA – the REMS Tracker.  This tracker is an Excel spreadsheet with links to letters of approval describing the REMS, a list of REMS elements required for each drug product, FDA’s stated rationale for requiring REMS, as well as other useful information.  (Thanks to our legal assistant Ted Kenyon for helping us to put this together!)  We will update this tracker on a regular basis as new approval letters are made available through FDA’s website.  Currently, 25 drugs and biologics have approved REMS.  We expect the number of REMS to grow significantly as FDA becomes more comfortable with its new power under FDAAA and as more decisions regarding class-wide REMS are finalized.   

By Kurt R. Karst –      

Last week, we reported on the third citizen petition submitted to FDA requesting that the Agency address whether the 30-month stay provisions of the Hatch-Waxman Amendments apply to a pending ANDA for a generic version of an old antibiotic drug, which ANDA contains a Paragraph IV certification to a patent listed in the Orange Book in accordance with § 4(b)(1) of the QI Program Supplemental Funding Act of 2008 (“QI Act”).  Now another citizen petition has been added to the mix. 

The latest petition, submitted on behalf of Stiefel Laboratories, Inc. (“Stiefel”), concerns the old antibiotic drug product EVOCLIN (clindamycin phosphate) Topical Aerosol Foam, 1%.  We previously reported that FDA’s Paragraph IV Certification List shows that an ANDA containing a Paragraph IV certification to a QI Act Orange Book-listed patent was submitted to FDA with respect to EVOCLIN.  Unlike the previously submitted citizen petitions, the Stiefel petition does not argue that the 30-month stay provisions of the original Hatch-Waxman Amendments apply, rather than the version of the statute amended by the Medicare Modernization Act (“MMA”), such that a generic applicant with a pending ANDA that amends its application to add a Paragraph IV certification to a later-listed patent is subject to a 30-month stay in connection with that certification.  Instead, Stiefel argues that:

The February 5, 2009 first applicant date is effectively the filing date under the unusual circumstances covered by the transitional rules.  This date, and not the actual date of the ANDA submission, is the most logical date to apply for purposes of determining the application of the 30-month stay.  Under this approach, the patents timely listed for covered old antibiotic drugs will predate the constructive application date for the Paragraph IV certifications.  As a result, the 30-month stay would be available, even under the restrictions imposed by the MMA. Only this interpretation provides necessary protection to old antibiotic drug NDA holders.  The availability of the 30-month stay should not be dependant solely on the arbitrary date of enactment of the QI Act.  Any interpretation and conclusion other than the one reached above unfairly singles out holders of NDAs for old antibiotic drug products that were approved prior to enactment of the QI Act and denies them the right to the 30-month stay provision to protect their intellectual property – a right that all other NDA holders of non-antibiotic drug products currently enjoy.  Application of ordinary Waxman-Hatch analysis, including restriction of the 30-month stay because of late listed patents, is not appropriate in this case as such analysis would fail to consider the unique factual and policy considerations raised in the isolated situation of the QI Act transitional rules.

The reference to February 5, 2009 is derived from QI Act § 4(b), which includes three transition provisions on Orange Book patent listing, certification, and 180-day exclusivity for each ANDA applicant that not later than 120 dates after enactment of the QI Act (i.e., February 5, 2009) amends a pending application to contain a Paragraph IV certification to a newly listed old antibiotic drug patent. 

The Stiefel petition goes on to argue that “[t]here is FDA precedence for developing and implementing unique transitional provisions that interpret statutory provisions in a manner that best reflects statutory intent.”  Specifically, Stiefel cites to FDA’s October 11, 1984 guidance for industry letter in which the Agency discussed its policies for converting and prioritizing “paper NDAs” into applications submitted under FDC Act § 505(j) in light of the enactment of the Hatch-Waxman Amendments.  In that letter, FDA provided a single date for ANDA conversion filings – i.e., November 26, 1984, when the then new ANDA provisions in the FDC Act became effective.