By William T. Koustas –

We previously reported that the United States District Court for the District of Columbia ruled in favor of the American Bar Association and prevented the Federal Trade Commission ("FTC") from enforcing its Red Flags Rule (“the Rule”) on attorneys.  On December 1, 2009, Judge Walton issued a written Opinion, explaining why the FTC’s application of the Red Flags Rule to attorneys violates the Administrative Procedure Act, 5 U.S.C. § 706(2)(C), because the Rule is in excess of the Government's statutory jurisdiction and authority.  American Bar Ass'n. v. FTC, No. 09-1636 at 1 (D.D.C. Dec. 1, 2009).  Although the ruling is in a case that relates specifically to the Rule's coverage of lawyers, there is language in the Opinion that may be highly beneficial to other businesses.

The Judge ruled that the Fair and Accurate Credit Transactions Act of 2003 (“FACT Act”),  on which the Rule is based, does not bring attorneys within the purview of the FACT Act and thus subject them to regulation by the Rule.  The Court also found that the lack of clarity in the FACT Act regarding its applicability to attorneys cannot be interpreted as authority for the FTC to regulate a profession that is traditionally regulated by the states.  Decision at 14.  As the Court explained, the FACT Act seems to contemplate the regulation of financial businesses.  It also concluded that another statute, the Equal Credit Opportunity Act (“ECO Act”),  which defines some of the terms used in the FACT Act such as "creditor" and "credit",  is targeted at credit applicants, but not lawyers. 

The Court also determined that the FTC’s “application of the Red Flags Rule to attorneys who invoice their clients is not reasonable,” and thus not entitled to "deference" by the Court.  Decision at 31.  The FTC argued that the definition of creditor under the ECO Act, as incorporated into the FACT Act, covers attorneys because they bill their clients for services rendered at the end of the month, rather than collect compensation for those services at the time the services are performed.  The Court, however, declined to permit such a broad interpretation of the term creditor and noted that “[t]o invoice [a] client at the end of each month is not delaying payment or giving a client a right to postpone payment.  As a practical matter in the legal context, legal services are not the type of services that can in many instances be billed and payment received simultaneously with the occurrence of the services . . . .”  Decision at 32-33. 

Although couched in terms of the typical arrangement between lawyers and their clients, this aspect of the Court's holding would appear to have much broader applicability to many other businesses.  It is quite common that companies sell goods or services to a customer and then send that customer a bill, expecting to be paid within a fairly short period of time.  The FTC has taken the position that this type of payment arrangement means that the company selling the goods and services has extended "credit" and has become a "creditor" subject to the Rule.  That position has been soundly rejected by the Court in the context of lawyers.  There does not appear to be any logical reason why a court would render a different analysis for businesses other than lawyers that simply send their suppliers a bill, expecting that payment will be made soon.

The Court found other reasons to rule that attorneys are not covered by the Rule.  For instance, the FTC never indicated that its definition of a creditor for the purposes of the Red Flags Rule would include attorneys during the rulemaking process.  Rather, that interpretation was only disclosed a year and a half after the Red Flags Rule was issued.  Therefore, the Court ruled that the FTC’s interpretation of the Red Flags Rule as applied to attorneys was “both plainly erroneous and inconsistent with the purpose underlying the enactment of the FACT Act.”  Decision at 40.

Procedurally, the Court's Decision resulted in the Court granting the ABA's Motion for Partial Summary Judgment.  It is quite noteworthy that the FTC has not issued any public statements regarding whether it intends to reissue the Rule, appeal the Court's ruling, seek further review from Judge Walton, or take some other action.

By Ricardo Carvajal –

FDA has issued a draft guidance that proposes a “preliminary” timetable for the agency’s review of applications for approval of modified risk tobacco products (MRTP’s).  FDCA section 911(a) prohibits the introduction of an MRTP into interstate commerce unless FDA has issued an approval order under section 911(g).  However, the statute does not specify a time limit for FDA’s review and decision on MRTP applications.  Instead, the statute allows FDA two years to issue a regulation or guidance that establishes a “reasonable timeframe” for its review.  The lack of a time limit for review was a key issue cited in a recent case challenging the constitutionality of the MRTP provisions (see our prior post).  Although plaintiffs in that case failed to secure a preliminary injunction, the court noted that the lack of a reasonable time limit for review of MRTP applications rendered the statute potentially vulnerable to a First Amendment challenge (“The Court thinks it likely that this two-year delay is unconstitutional given that certain portions of the MRTP provision have been in effect since June 22, 2009”).

FDA’s draft guidance appears to address that vulnerability by establishing a “reasonable preliminary timetable” of 360 days.  In doing so, FDA dismissed the 180-day time period for review of drug and device applications as too short, given the statutory requirements that FDA seek public comment on MRTP applications and also refer them to the Tobacco Products Scientific Advisory Committee.  FDA also tentatively dismissed the 540-day time period for review of health claims as unnecessarily long, given that notice-and-comment rulemaking is not required for a decision on an MRTP application.  The draft guidance signals that the agency expects to issue more detailed guidance or regulations once it has acquired a base of experience with processing MRTP applications.  In the interim, the guidance suggests that the first MRTP applicants may be in for a rough ride:

The Agency has not yet received an MRTP application. It therefore does not have experience in reviewing such applications, and has no information based on prior experience regarding the length of time required for review of such applications. Moreover, the MRTP application review process and approval criteria are new, and the Agency is likely to encounter a number of questions of first impression involving science, law, policy, and procedure. Resolving questions of first impression may mean that the initial applications will require more time than later submitted ones.

Comments on the draft guidance are due by February 25, 2010.

By Carrie S. Martin –      

On November 19, the Washington Legal Foundation (“WLF”), along with three other organizations, filed an amicus curiae brief in support of Allergan, Inc.’s First Amendment challenge to FDA’s ban on “truthful, accurate and nonmisleading speech” proactively disseminated to health care professionals (“HCPs”) about off-label uses of FDA-approved prescription drugs.  

On October 1, Allergan filed a Complaint and a Motion for Preliminary Injunction in the United States District Court for the District of Columbia to prevent the FDA and the federal government from enforcing regulations and policies that would prohibit Allergan from proactively sharing information with HCPs on an off-label use of BOTOX (botulinumtoxin type A) for injection to treat spasticity in certain patients.  Allergan stressed that it was “not seek[ing] to engage in direct-to-consumer communications about the off-label use of Botox,” but instead wanted to inform HCPs about safety data regarding the use by distributing safety information to physicians who treat spasticity through “medical and scientific representatives,” distributing printed and electronic information to physicians, and making formal presentations at scientific meetings and conventions, among other things.  As Allergan points out, this speech currently runs afoul of FDA regulations and government policies and renders a company vulnerable to criminal prosecution and civil penalties.
 
Such policies and regulations regarding off-label communications, according to Allergan, violate the First Amendment and are patently inconsistent with the Federal Food, Drug, and Cosmetic Act (“FDC Act”).  In addition, the regulations and policies “impair[] public health and safety” by prohibiting the company from disseminating information about risks of serious adverse events to physicians already using Botox for this off-label use. 

Allergan attributes the overly restrictive regulatory landscape to the expansion of several related and intertwined regulations and policies.  Among them is the “radical[] expan[sion]” of the regulatory definition of “labeling” to include any material that contains company-generated and distributed information about a drug, whether or not it physically “accompan[ies]” it, 21 C.F.R. § 202.1(l)(2), which in turns makes it unlawful for a pharmaceutical company to distribute material about an off-label use under the FDC Act, because such information renders the drug a “new drug.”  In addition, because the federal government considers all speech about an off-label use “false or misleading,” such speech misbrands a drug under section 502(a) of the FDC Act. 

WLF’s brief supplements Allergan’s complaint by expounding on two topics: (1) the importance of off-label uses to the practice of medicine and how overregulation of off-label speech is contrary to public health; and (2) the “three foundational First Amendment principles” necessary to resolve Allergan’s claims.  With regard to the first topic, the brief stresses that manufacturers are in the best position to provide important off-label information because they – simply put – have the best access to and understanding of that information and the resources to disseminate it.  In addition, the amici curiae argue that this information is critical to HCPs, because, among other reasons, off-label uses of prescription drugs often constitute the standard of care. 

With regard to the “foundational First Amendment principles,” the brief notes that the First Amendment is always implicated when the government limits truthful, accurate and non-misleading speech, including when such speech is from a manufacturer regarding off-label uses of approved drug products.  Furthermore, the speech at issue here—truthful, nonmisleading speech from a prescription drug manufacturer to HCPs about the safety and efficacy of an off-label use of a prescription drug – is not commercial, but rather scientific speech that receives “strict scrutiny” in a First Amendment analysis.  According to the brief, the fact that the manufacturer may benefit financially from that speech does not automatically make it commercial speech.  And even if the speech was commercial, which receives intermediate scrutiny, the WLF brief argues that the government’s restrictive policies and regulations would still be found unconstitutional, because the “First Amendment forbids the government from paternalistically limiting the flow of information to the marketplace concerning lawful transactions in lawful products.”  

A hearing on Allergan’s Motion for Preliminary Injunction has been set for March 2010.  Regardless of the outcome, it is likely that this fight – given its history and its potential impact on manufacturers and the federal government – will not end until it reaches the steps of the United States Supreme Court.

Thanks to our faithful readers, we made the list for the Third Annual ABA Journal Blawg 100.  One of our readers, an FDA official, said that “there is no one within the agency that does what this blog provides.”  We are humbled by this honor and hope to continue to provide useful information and analysis on food and drug law for years to come. 

By Jeffrey N. Wasserstein –

We missed this interesting decision in the run-up to Thanksgiving.  Now that we’ve recovered from our tryptophan-induced sleepiness, we found this case to be of particular interest.  We previously blogged on the Cell Therapeutics Inc. (“CTI”) case.  To sum up that case, the complaint had alleged that CTI promoted TRISENOX (arsenic trioxide) for off-label uses, which caused doctors to prescribe TRISENOX and submit claims to Medicare for uses not approved or medically accepted.  The Complaint in Intervention also alleged that CTI implemented a plan to convince physicians and Medicare carriers that various off-label uses of TRISENOX were medically accepted and eligible for Medicare reimbursement.  CTI settled with the government for $10.5 million.

CTI then sued the Lash Group, a reimbursement consulting firm, for indemnification and other independent claims, arising out of the reimbursement advice that the Lash Group provided to CTI.  The district court had held that CTI’s qui tam settlement barred a suit for indemnification and other causes of action, since the Lash Group was effectively a co-participant in the scheme to defraud the government.  (The government intervened in the qui tam suit against CTI, but not the Lash Group, which settled with the relator in 2008.) 

On appeal, the Ninth Circuit held that a qui tam settlement was not a bar, since it was a settlement, not a “de facto finding of liability.”  The Court stated that generally, a settlement agreement under the False Claims Act would not necessarily bar non-False Claims Act claims against a third party, and sent the case back down to the district court for further proceedings.  Since pharmaceutical and medical device companies rarely plan reimbursement strategies without outside consultants, this case is important to companies and consultants alike.

By Kurt R. Karst –    

Returning from the Thanksgiving Holiday, we found our inbox chock-full of recent preemption decisions of note involving generic drugs. 

First off is a decision from the U.S. Court of Appeals for the Eighth Circuit in Mensing v. Wyeth.  That case involves generic REGLAN (metoclopramide), allegations that use of the drug caused tardive dyskinesia, and an appeal from an October 2008 decision from the U.S. District Court for the District of Minnesota in which the court dismissed, among other things, certain tort claims (failure to warn and misrepresentation) against generic manufacturers of metoclopramide on the basis of federal preemption.  In reversing the district court’s decision on this point, the Eighth Circuit, following a rationale harkening back to the recent decision from the U.S. District Court for the District of New Hampshire in Bartlett v. Mutual Pharma. Co. (see our previous post here), ruled that the plaintiff stated a viable claim against generic metoclopramide manufacturers.  Some of the more notable passages from the decision include:

• The Hatch-Waxman Amendments are part of this 70 year history and they do not explicitly preempt suits against generic manufacturers. Congress could have crafted a preemption provision for generic drugs in its 1984 amendments, having done so for medical devices less than 10 years earlier. It chose not to do that. . . . After [Wyeth v. Levine], we must view with a questioning mind the generic defendants' argument that Congress silently intended to grant the manufacturers of most prescription drugs blanket immunity from state tort liability when they market inadequately labeled products.

• The parties agree that generic labels must be substantively identical to the name brand label even after they enter the market. . . .  Because of this requirement, the generic manufacturers argue they are prohibited from implementing a unilateral label change without prior FDA approval through the [Changes Being Effected (“CBE”)] process.  Yet, 21 C.F.R. § 314.97compels generic manufacturers to “comply with the requirements of §[] 314.70[.]”  Section 314.70 includes the CBE process and the prior approval supplement process.  In this case we need not decide whether generic manufacturers may unilaterally enhance a label warning through the CBE procedure because the generic defendants could have at least proposed a label change that the FDA could receive and impose uniformly on all metoclopramide manufacturers if approved.  [(italics in original)]

• In addition to proposing a label change, the generic manufacturers could have suggested that the FDA send out a warning letter to health care professionals.  When the FDA first adopted its labeling regulations, well before the Hatch-Waxman Amendments, it stated that the requirements “do not prohibit a manufacturer . . . from warning health care professionals whenever possibly harmful adverse effects associated with the use of the drug are discovered.”  44 Fed. Reg. 37434, 37447 (June 26, 1979); see also CDER, Manual of Policies and Procedures (MAPP) 6020.10, NDAs: “Dear Health Care Professional” Letters (July 2, 2003) (guidance document to name brand manufacturers stating that the letters may be ordered by the FDA or sent by manufacturers without FDA involvement).

The second decision of interest is from the U.S. District Court for the Northern District of California (San Jose Division) in Gaeta v. Perrigo.  In that case, the court denied Gaeta’s Motion for Reconsideration of a pre-Levine Order granting Perrigo’s Motion for Summary Judgment.  The pre-Levine Order found that Gaeta’s state law causes of action were preempted to the extent that they allowed for liability based on a lack of adequate warning on Perrigo’s over-the-counter ibuprofen drug product.  Gaeta argued that “although the specific facts of Levine involved a brand-name drug, the Court’s holding was broad enough to also encompass the interaction between FDA regulations and state tort law with regard to generic drugs.”  The court disagreed, however, ruling that “Levine does not govern whether the Court may grant summary judgment on Plaintiff’s state tort claims,” because “Levine did not address a dispositive issue in this case, namely, whether a generic drug manufacturer may use the CBE process to make warning-label changes without prior FDA approval.”

The applicability of the Supreme Court’s decision in Levine to generic drug manufacturers was also noted – more specifically, sidestepped – in a third recent ruling.  In Morris v. Wyeth, which again involves metoclopramide, the U.S. District Court for the Western District of Louisiana (Monroe Division) granted a Motion for Summary Judgment in favor of the brand-name drug manufacturers because the plaintiff in the case did not consume REGLAN, but rather a generic version.  The court stated that “Levine held only that the FDA’s approval of a branded drug’s labeling does not preempt a plaintiff’s state law failure-to-warn tort claim against the manufacturer of the branded drug.  Levine certainly does not stand for the proposition that the brand-name manufacturer of a drug may be held liable under the law of Louisiana for the warning provided by a generic manufacturer.”  The court goes on to comment in a footnote, however, about the applicability of Levine to generic drug manufacturers:

Levine did not address generic drugs and if or how its analysis might apply to claims against generic drug makers.  The Court is aware that generic drug manufacturers continue to argue that failure to warn claims against them are preempted because they are bound by FDA regulation to conform their labels to that of the brand-name drug. . . .  However, . . . that issue is not before the Court in this motion. . . .  The Court recognizes the inequity that may result if a plaintiff who was harmed by a generic drug is preempted from obtaining damages from the generic manufacturer on the basis of its failure to warn, but also has no cause of action against the name-brand manufacturer who prepared the warning used by the generic manufacturer.  Nevertheless, these are two separate legal issues, and the Court cannot render a finding of liability . . . based on the possibility that the generic manufacturers . . . may or may not have a preemption defense to Plaintiffs' failure-to-warn claim.    

Although legislation has been proposed that would preempt tort suits against generic drug makers, it does not appear to have made it into the current version of the House and Senate health care reform bills.

By J.P. Ellison –      

Earlier this month a federal district court in Georgia granted summary judgment in a Lanham Act suit that raised a number of FDA issues.  The plaintiff in the suit manufactured two prescription acne products under the trade name Benziq.  Defendant manufactured two products under the name Benprox that competed with plaintiff’s products. 

The plaintiff alleged that defendant violated the Lanham Act, a federal cause of action that provides a remedy to plaintiffs harmed by false or misleading commercial advertising or promotion by a competitor.  In this case, the plaintiff alleged that the defendant’s false and misleading statements took two forms:  (1) submissions to third party pricing services; and (2) product labeling. The court granted the defendant’s motion for summary judgment on both grounds.

Before considering those claims, the court addressed a threshold issue that often arises in Lanham Act suits that implicate FDA issues, namely whether a Lanham Act suit is precluded because the substance of the allegations are the province of the FDA.  In this case, after examining a number of the prior cases, the court concluded that it could address the claims raised.

On the plaintiff’s first theory, that the defendant’s submissions to third party pricing services were false and misleading, the court ruled that the plaintiff’s had not presented any evidence of falsity.  On the plaintiff’s second theory, that the product labeling was false and misleading, the court ruled that plaintiff’s arguments either required interpretation of an issue on which FDA had not provided guidance, or in the alternative that plaintiff’s had failed to present evidence to support that theory.

In sum, the Court’s opinion is fairly fact specific, but nevertheless provides an overview of the issues that arise in Lanham Act cases that implicate FDA issues.

By Riëtte van Laack –

In two little noticed speeches delivered at the Council for Responsible Nutrition’s ("CRN’s") Annual Symposium on October 22, 2009, FTC’s Director David Vladeck and FDA’s Principal Deputy Commissioner Joshua Sharfstein set out their agencies’ priorities for regulation of dietary supplements.  For FTC, a continuing priority is advertising substantiation.  Mr. Vladeck, in his speech, stressed that it is not just the ultimate advertiser that will be held liable for substantiation.  In addition, those who are the source for the advertising claims, including ingredient suppliers and contract manufacturers, are responsible for claims that they make to their (trade) customers. 

Vladeck also mentioned the new guidelines on the use of endorsements that we addressed in a previous post.  FTC intends to aggressively enforce the guidelines.  Any advertiser will be held to the same standard of substantiation of competent and reliable scientific evidence, including advertisers who use endorsements or testimonials. 

Vladeck acknowledged that the recent court decision in the Lane Labs case has raised questions about what constitutes competent and reliable evidence.  Therefore, in future injunctive orders, FTC intends to provide more precise language to describe what type of evidence is required.  What is clear from FTC’s perspective is that evidence from one or two studies contradicting or inconsistent with the weight of the evidence is not sufficient to substantiate a claim – even when those studies are performed according to standard, reliable, scientific protocols.

FTC and FDA intend to increase their level of cooperation.  This increased cooperation is particularly evident in the area of enforcement activities directed toward dietary supplements that pose a serious health concern because they carry claims for serious diseases such as cancer or the H1N1 flu. As an example, see the recent joint warning letter issued to DrWeil.com and Weil Lifestyle LLC, 

FTC and FDA also intend to pursue dietary supplements that present undisclosed health risks because the products have been spiked with pharmaceutical substances.  Both FTC and FDA are struggling with the best approach to this problem.  In his remarks at the CRN Symposium, Dr. Sharfstein pointed out that FDA is pursuing criminal investigations in this area.  He further mentioned the dietary supplement GMP regulation, and adverse event reporting requirements as potential tools to address the problem.  In addition, Dr. Sharfstein suggested that stricter enforcement of the requirement to notify FDA of intent to market a new dietary ingredient might be an avenue to address the problem.  Such a notification provides FDA with an opportunity to review the safety of a new dietary ingredient and its use. 

In his remarks, Dr. Sharfstein suggested that a notification is required for any new dietary ingredient.  However, under section 413(a)(1), submission of a notification is not required if “[t]he dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.”  Dr. Sharfstein also suggested that guidance on what constitutes a new dietary ingredient subject to notification may be forthcoming, and that the agency intends to clarify its standards for such notifications.  (We note that the agency has been working on guidance in this are for years, and held a public hearing on this subject in November of 2004.) 

All of these agency activities notwithstanding, Dr. Sharfstein reminded his audience that every company in the dietary supplement industry is ultimately responsible for the safety of its products. 

By Alan M. Kirschenbaum –

Yesterday, the Senate voted 60 to 40 to send its 2,074-page health care reform bill, the “Patient Protection and Affordable Care Act,” to the floor for debate.  The bill represents a merger of two bills reported by the Senate Finance Committee and the Senate Committee on Health, Education, Labor, and Pensions, respectively.  Like its House counterpart, the Senate bill contains major changes to the Medicaid Rebate Program, Medicaid drug reimbursement, Medicare Part D, the 340B Drug Discount Program, and the Federal Food, Drug, and Cosmetic Act, as well as new physician payment reporting requirements for drug and device companies.  As we previously did for H.R. 3296, the health care reform bill that passed the House on November 7, we have prepared an outline summarizing the most significant drug- and device- related provisions of the Senate bill.  The outline can be found here.  The Democratic leadership of the Senate expects to debate the bill and vote on it by the end of December.

By Kurt R. Karst –

In June, we reported on a citizen petition Galderma Laboratories L.P. (“Galderma”) submitted to FDA requesting that the Agency interpret the QI Program Supplemental Funding Act of 2008 (“QI Act”) to impose a 30-month stay of approval on an ANDA referencing the old antibiotic drug product ORACEA (doxycycline) if that ANDA contains a Paragraph IV certification to a patent that was listed in the Orange Book in accordance with § 4(b)(1) of the QI Act.  The QI Act amended the FDC Act to add § 505(v) to create Hatch-Waxman benefits for “old” antibiotics.  FDA previously denied several petitions (see our previous post here) that argued a 30-month stay should apply.

Galderma states that its citizen petition is “entirely distinguishable” from the previous QI Act 30-month stay citizen petitions submitted to FDA: “Unlike prior petitioners, Galderma does not contend that Congress, via the QI Act, directed FDA to apply the applicable statutory provisions of the original Hatch-Waxman Amendments as enacted in 1984, rather than as subsequently amended by Congress.”  Furthermore, Galderma states that the company “agrees with FDA’s Denial Letter that ‘it is reasonable, both as a matter of statutory construction and sound public policy, to interpret section 505(v)(4) [of the QI Act] to require the application of the current law to old antibiotics . . . there is a strong argument that Congress intended this result.’” 

Indeed, according to Galderma, “this is precisely Galderma’s position – that Congress clearly intended to treat ‘old antibiotics’ consistent with ‘new antibiotics’ pursuant to current law, and that a single 30-month stay should apply to both classes of products.”  Galderma summarizes its argument as follows:

[N]o previous petitioner argued, as this petitioner does, that the intent of Congress, embodied in the terms of the transition provisions of the QI Act, was to grant the opportunity to obtain both a single 30-month stay of ANDA approval and 180-day generic exclusivity to the holders of NDAs and ANDAs covered by the Q1 Act.  Although FDA addressed certain issues related to this petition in its recent Denial Letter, FDA has not directly addressed the issues raised herein as applicable to ORACEA.

Earlier this month, FDA denied Galderma’s petition.  FDA’s response indicates that the Agency did not, in fact, consider Galderma’s arguments to be “entirely distinguishable” from those raised in the previous QI Act 30-month stay petitions:

There is no evidence that Congress intended to link the QI Act’s 60-day transitional requirement for patent submissions to the availability of a 30-month stay. . . .  After consideration of the Petitioner’s arguments, comments thereto, statutory language, and legislative history associated with the development of antibiotic regulation, the Agency has concluded that the transition provisions of the QI Act do not impose a 30-month stay of approval on an ANDA as to which the NDA holder or patent owner has initiated patent litigation as a result of the ANDA applicant’s notice of paragraph IV certification, when the ANDA was pending with FDA at the time the patent claiming the old antibiotic drug was submitted to the Agency for listing. 

Now that FDA has responded to 5 citizen petitions concerning QI Act 30-month stay issues, the issue has presumably been put to rest.  Other QI Act implementation issues remain, however, including those raised in a January 2009 letter from the American Intellectual Property Law Association to FDA.

By Dara Katcher Levy

On November 12 and 13, FDA held a Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.  The hearing represents FDA’s second attempt at gathering information on using the internet to promote medical products – the first taking place in October 1996.   As we all are keenly aware, FDA did not issue any guidance to industry on the use of the internet as a result of that meeting.

The 12 member FDA panel listened to about 78 presenters over the course of two days.  Although the panel asked a few questions, they made no suggestions regarding how they intend to address the two main issues as expressed at the hearing:   How do the requirements in 21 CFR Parts 201 and 202 relate to certain internet/social media-related activities; and what are manufacturers’ responsibilities with regard to monitoring and subsequently reporting adverse events identified on the internet and/or through social media tools.  

The hearing was mainly an opportunity for marketing agencies to “display their wares” with regard to the social media tools available to regulated industry, and to complain about the reluctance of industry to utilize these cutting-edge tools because of the lack of clarity surrounding industry’s obligations.  Several companies and trade associations took the opportunity to discuss their participation in social media and what industry’s obligations should be.  PhRMA was one of the few presenters that had a creative and specific suggestion on how to manage fair balace requirements in the social media world – the creation of an FDA logo along with a generalized risk statement that hyperlinked to FDA-approved product-related content.  At least one presentation suggested that FDA consider requiring third party websites, such as drugs.com, to contain all FDA-approved product information.  And finally, the problems with Sidewiki were addressed by many presenters, with the notable exception of Google.

The docket for submitting comments on the use of internet and social media to promote medical products remains open until February 28, 2010.  Let’s hope that this time FDA doesn’t stick its head in the sand for another 13 years.

By A. Wes Siegner, Jr. and Ricardo Carvajal  
 
Sen. Kerry has introduced the Medical Foods Equity Act of 2009 with the goal of securing insurance coverage for certain medical foods.  The legislation would secure coverage under federal insurance plans (e.g., Medicaid and Medicare), plans governed by the Employment Retirement Income Security Act (ERISA), and plans on the individual and group markets for the following types of food:

medically necessary food and food modified to be low protein that is  formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC);

pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the ACHDNC and as prescribed by a qualified medical provider.
 
The legislation defines “medically necessary food” in a manner that is generally consistent with the definition of "medical food" in section 5(b) of the Orphan Drug Act (21 U.S.C. § 360ee(b)(3)), and includes both “nutritionally modified counterparts of traditional foods” and “other forms of foods such as formulas, pills, capsules, and bars, so long as consumed or administered enterally.” 
 
As matters now stand, coverage of medical foods by insurance plans appears to be fairly widespread.  Although this proposed legislation would secure coverage for the types of medical foods that fall within its narrow scope, it could well have the effect of reducing existing coverage for other types of medical foods.  Whether efforts to broaden the scope of the legislation would be successful is open to question, given rumblings of discontent from FDA suggesting that the agency views the medical food category as ripe for a crackdown.

Hyman, Phelps & McNamara, P.C. is very pleased to announce that J.P. Ellison and Kurt R. Karst have been named Directors of the firm. Mr. Ellison works primarily on civil and criminal litigation matters, including pre litigation enforcement matters likely to lead to litigation.  Mr. Karst focuses primarily on Hatch-Waxman and drug development issues. 

By David B. Clissold and Ricardo Carvajal

The Center for Tobacco Products has scheduled a web-based training session on use of the eSubmitter program to electronically submit establishment registration and product listing information (see here).  Submission of that information by December 31 is required under FDCA section 905.  Those who are interested in participating are directed to provide their Company name and contact information to eSubmitter@fda.hhs.gov by noon on Wednesday, November 18.  FDA advises that, in the absence of sufficient interest, the training may be cancelled.

By Jeffrey N. Wasserstein

Your faithful bloggers at FDA Law Blog are, as you might expect, big fans of social media tools.  After all, we blog, we tweet, and we are on LinkedIn, and Facebook (but no, we’re not friending all of our readers).  (We also have a neat Web 1.0 website.)  But one new social media tool leaves us, along with much of the pharmaceutical and medical device world, slightly befuddled, and we hope that FDA, in deciding how to regulate Web 2.0 offers up some guidance on how to deal with Google’s Sidewiki.

For all you 20th Century types who aren’t familiar with Sidewiki, it is a new app from the Google toolbar that essentially allows users to comment or discuss any website on that website.  The comments are available to any user of Google toolbar and appear in association with a particular website, although the comments are actually hosted by Google, not the owner of the website.  What Sidewiki does is convert a standard Web 1.0 static one-way website (website to reader) into a Web 2.0 two way fluid website, since users can add their own commentary and criticisms to the website.

Well that’s wonderful, you are thinking, greater information sharing is wonderful in our Web 2.0 world!  Information wants to be free!  The only problem, for you pharma or medical device types, is how is this going to be regulated?  What happens if someone posts an adverse event on the sidewiki associated with your website?  What if a user (hopefully not one of your sales reps) posts a comment about the wonderful off label uses of your products?  What happens if a competitor trash-talks your products?  Not so wonderful now, is it?

Marketing will want to control the wiki, drug safety will want to ban company personnel from it lest they find more adverse events, and the lawyers out there (self included) will grumble that it would be nice if FDA gave more clarification about these things.  (And no, warning letters are not clarification!) 

One solution is complete involvement.  Have someone monitor the discussion, and, where appropriate, correct off label comments and other inappropriate discussions.  They would refer any potentially identifiable adverse events to the drug safety or postmarket surveillance departments.  Another solution is to be completely hands off.  Don’t allow anyone from the company to get involved, and perhaps not even to read the comments (but oh so tempting to know what people are saying, isn’t it?)

One company has taken somewhat of an intermediate tact.  Astra Zeneca (AZ) put a comment in the sidewiki for the AZ website (and since it always appears on top of all the comments, it’s a sticky wiki.  Sorry, couldn’t resist).  The comment notes that AZ doesn’t monitor the sidewiki comments, and that readers shouldn’t expect any type of response.  They gave alternative website and email contact information for users to use if they needed a response.  Assuming they’ve also instructed employees not to post on the sidewiki, they’ve protected themselves to some degree.  We’re not sure whether this provides adequate protection if an identifiable individual discloses an adverse event and it turns out that AZ personnel do monitor the sidewiki, but lawyerly small print can’t protect against all risks.

Many FDA-regulated companies have avoided setting up an online forum for consumers or patients  for fear of not knowing how far to regulate the discussions.  Perhaps sidewikis will force their hands, since Google does not seem to allow the companies to opt out at this time.  Once a company is forced to deal with someone else’s forum, perhaps other social media tools will come easier.  Perhaps not.  (How do you fit fair balance in 140 characters on Twitter?)

This is a brave new world we’re in, and it seems that www is increasingly standing for “wild, wild, West.”  And while we can hope (or grumble) for FDA to give some guidance as to how to handle the increasing morass that is the world wide web, perhaps in time for Web 3.0, playing the ostrich and hoping the internet goes away is simply not an option.