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. 

By Kurt R. Karst –      

Buried in the Conference Report (Report No. 111-279) accompanying the recently-enacted Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2010 (Public Law No. 111-80) is a request that FDA examine and report on “A” rated anti-epileptic drugs (i.e., drug products that FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products).  According to the Conference Report:

The conferees request the FDA report on adverse events and seizures associated with brand and generic anti-epileptic drugs.  Specifically, the agency should examine the pharmacokinetic profiles of “A” rated anti-epileptic drugs from different manufacturers of the same therapeutic agent.  The Committee directs the FDA to submit a report not later than September 30, 2010, detailing whether the agency believes that any changes to the current bioequivalence testing should be recommended.

The request from Congress is presumably related to questions that have been raised over the past several years about generic anti-epileptic drugs, and in particular, whether there is an increased risk of so-called “breakthrough” seizures or toxic side effects when patients are switched from a brand name anti-epileptic to a generic version.  These issues have been the topic of many reports (here and here), including, for example, a 2008 article in the publication NEUROLOGY in which the authors concluded that FDA bioequivalence testing “may not be adequate for [anti-epileptic drugs] and suggests that more clinical evidence is needed.” 

FDA (or at least one FDAer) has stated that it is confident in its generic anti-epileptic drug approvals (a sentiment that has been echoed by the Academy of Managed Care Pharmacy), and the Agency is reportedly in the process of working on studies to address the questions that have been raised about generic anti-epileptic drugs.  Although a citizen petition was submitted to FDA in 2006 requesting that the Agency address the issue of brand name and generic anti-epileptic drug substitution, the Agency has not yet substantively responded to the petition.  Specifically, the petition requests that FDA: (1) require all anti-epileptic drugs to include a warning to exercise extreme caution when switching those products; (2) include a discussion in the Orange Book Preface at § 1 .8 (Description of Special Situations) of the risks associated with switching anti-epileptic drugs; and (3) narrow its bioequivalence range for anti-epileptic drugs to require a showing, at the 90% confidence interval, that the lower limit is at least 90% of its reference listed drug.

FDA’s report to Congress should go a long way to address the long-standing controversy over anti-epileptic drug substitution issues. 

By Ricardo Carvajal –

FDA and USDA’s Food Safety Inspection Service (“FSIS”) announced a public meeting intended to “stimulate and focus a discussion about mechanisms to enhance product tracing systems for food” that will “help FDA and FSIS determine what short and long term steps the two agencies should take to enhance  the current tracing system for food.”  The Federal Register notice explores some of the problems with the current tracing system that have been brought to light by recent contamination events, and requests comments and data on a number of issues, including:

• What should be the core elements of a product tracing system (e.g., what information elements should be included, and how far up and down the chain of distribution should those elements be transmitted)?
• What records should be kept by which parties in the chain of distribution, and in what format?
• Should enhancements to the current system be risk-based?
• What would be the costs and benefits of implementing an enhanced  system, and is such a system feasible?

A critical question is whether, and to what extent, there is a need to move from the current “one up/one down” system to a “whole chain” system, which would enable linking a particular food to its manufacturer, ingredients, origin, chain of distribution, and transporter – at any stage of the supply chain.  The Food Safety Enhancement Act of 2009 (“FSEA”), recently passed by the House, would explicitly authorize FDA to issue regulations requiring those who produce, manufacture, process, pack, transport, or hold food to adopt a “whole chain” system.  However, FDA would first be required to identify tracing technologies, hold a public meeting, and conduct pilot projects to explore and evaluate tracing systems.  The recently announced public meeting should give FDA a head start on these requirements, should FSEA or something like it become law.  If FSEA does not become law, then FDA will have to grapple with the issue of how far it can go in remaking the current system under the agency’s existing legal authorities.

By Michelle L. Butler –

Yesterday, the Consumer Product Safety Commission (“CPSC” or “Commission”) held a public hearing on the draft guidance document proposed by the Commission staff regarding “Testing and Certification Requirements Under the Consumer Product Safety Improvement Act of 2008.”   The hearing was conducted via webcast and can be viewed here.  The hearing focused on the requirements for certification for consumer products, including children’s products, and did not discuss the applicability of the guidance document to Poison Prevention Packaging Act (“PPPA”)-regulated products.  During the hearing, the Commissioners asked many questions of the Commission staff regarding what was intended by portions of the guidance document and requested clarification on a number of issues in the next draft of the guidance document that will be submitted to the Commission.  For example, there appeared to be some confusion regarding certification for children’s products until the time that the CPSC has accredited third party conformity assessment bodies to conduct tests for particular standards (i.e., would a general certificate of conformity be required utilizing a “reasonable testing program” until such time as the CPSC has accredited entities to conduct third party testing for a particular standard, or will the requirement for certification as to that standard continue to be stayed until the CPSC has finished its accreditation process). 

In addition, a number of the questions posed by the Commissioners indicated a desire for the CPSC staff to make sure that the impact of the guidance document on small businesses is assessed and considered.

The Commissioners also mentioned a workshop that is scheduled for December 10-11, 2009 regarding testing, certification, and labeling pursuant to the certification requirements in section 14 of the Consumer Product Safety Act.  Interested parties are invited to participate, attend, or submit comments.

The Commissioners made no indication that the stay of enforcement of the CPSIA testing and certification requirements, which is now in place until February 2010, would be extended, but they did note that the stay can be lifted only upon the Commissioners’ vote.  They also noted that the Commission understands that a decision regarding the stay should be made sooner rather than later.
 
We will continue to monitor developments regarding the certification requirements, particularly as those requirements might affect PPPA-regulated products.

By Kurt R. Karst –      

The U.S. District Court for the Western District of Kentucky (Bowling Green Division) denied a Motion for Preliminary Injunction in a case concerning the Constitutionality of the recently enacted Family Smoking Prevention and Tobacco Control Act (“FSPTCA”).  As we previously reported, five tobacco manufacturers (including R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, and Commonwealth Brands, Inc.) and a retailer of tobacco products filed a Complaint in August alleging that certain FSPTCA provisions concerning Modified Risk Tobacco Products (“MRTP”) violate their First Amendment right to engage in commercial speech. 

The MRTP provisions of the FSPTCA (FDC Act § 911) prohibit the introduction into interstate commerce of any tobacco product that is “sold or distributed for use to reduce harm or the risk of tobacco-related disease,” which means a product:

(i) the label, labeling, or advertising of which represents explicitly or implicitly that –

(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;

(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or

(III) the tobacco product or its smoke does not contain or is free of a substance;

(ii) the label, labeling, or advertising of which uses the descriptors “light”, “mild”, or “low” or similar descriptors; or

(iii) the tobacco product manufacturer of which has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product's label, labeling, or advertising, after June 22, 2009, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.

To market an MRTP, a company must first file an application with the Department of Health and Human Services Secretary.  The application is made available for public comment and is referred to the Tobacco Products Scientific Advisory Committee for a recommendation.  An MRTP application may be granted if it is determined that the applicant has demonstrated that “the product, as it is actually used by consumers, will (1) significantly reduce harm and risk of tobacco-related disease to individual tobacco users; and (2) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”

The Plaintiffs contended in their briefs (here, here, and here), among other things, that the MRTP provision is: (1) “a viewpoint-based restriction on core First Amendment speech . . . subject to strict scrutiny” which fails to pass review because “it is not necessary to serve the asserted interest;” (2) an unconstitutional prior restraint because it “lacks any of the constitutionally-mandated procedural safeguards that the Supreme Court requires of prior restraints under any level of scrutiny;” and (3) void for vagueness.  FDA countered in its brief that “the statutory provisions regulating [MRTPs] do not restrict speech; they restrict the distribution of certain products without FDA review,” that strict scrutiny is inapplicable, and that even if the commercial speech test applies, “[t]he dangers of products sold or distributed as modified risk tobacco products that do not in fact reduce risk are so high that there is a compelling governmental interest in ensuring that statements about modified risk tobacco products are complete, accurate, and relate to the overall disease risk of the product” and the FSPTCA is narrowly tailored to advance that important governmental interest.  (Eleven non-profit public health organizations and consumer advocacy groups, including the Campaign for Tobacco-Free Kids and the American Cancer Society, supported FDA’s position in an amicus brief.) 

After assuming “for purposes of this preliminary injunction motion that the MRTP provision regulates speech and must satisfy the First Amendment,” the court stated that “it seems likely that its restrictions on speech are constitutionally permissible” using the familiar test for government regulation of commercial speech that was announced by the Supreme Court in Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980).  In particular, the court noted that the government has a substantial interest in protecting consumers from misleading tobacco industry claims about allegedly reduced risk tobacco products because of the “significant health risks associated with the use of tobacco products and the history of marketing ‘low tar’ and ‘light’ cigarettes, that the government adequately demonstrated that “the harms it recites are real” and that the FSPTCA’s MRTP provision will “alleviate [the harms] to a material degree,” and that there is “at least a reasonable fit between the means and ends of the MRTP regulatory scheme.” 

After considering each of the factors for granting a preliminary injunction, the court ruled that such a remedy is unwarranted.  The court did note, however, that the Plaintiffs have some likelihood of success on the theory that the MRTP provision operates as a prior restraint and lacks a reasonable time limit for review:

Under the MRTP provision, tobacco manufacturers must submit not only the would-be modified risk product but any “proposed advertising and labeling” and “sample product labels and labelling” to the FDA for review. . . .  Thus, any such proposed speech about a modified risk tobacco product is effectively silenced until the FDA issues a decision. Because this is so, the reasonable time limit safeguard is necessary to satisfy the “principle that the freedoms of expression must be ringed about with adequate bulwarks.”  Bantam Books, Inc. v. Sullivan, 372 U.S. 58, 66 (1963).  At this point, such a time limit is missing.  While Congress has charged the FDA with “establish[ing] a reasonable timetable for the Secretary to review an application under this section,” it has given the FDA two years to come up with one. . . .  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.

On that basis, the court concluded that the first factor of the preliminary injunction analysis – i.e., whether the Plaintiffs have a strong likelihood of success on the merits – was not determinative and proceeded to analyze the other three preliminary injunction factors.

It is unclear whether the Plaintiffs in the case will appeal the ruling.  There has been significant speculation that the U.S. Supreme Court will ultimately be asked to rule on the Constitutionality of the FSPTCA.  Meanwhile, FDA continues to flex its new enforcement muscles granted to the Agency under the FSPTCA.  Last week, FDA announced that it issued several Warning Letters to companies marketing illegal flavored cigarettes.  FDA has also been sued by a cigar importer and distributor in connection with FDA statements regarding flavored cigarettes.

By Anne Marie Murphy –

The Consumer Product Safety Improvement Act of 2008 (“CPSIA”) made significant changes to the laws enforced by the Consumer Product Safety Commission (“CPSC”).  CPSIA Section 102 amended the Consumer Product Safety Act (“CPSA”) to require that manufacturers certify that their products are in compliance with any applicable CPSC rule, standard, or ban.  In February of this year, citing industry confusion as to which testing and certification requirements apply to which products, the CPSC announced a one-year stay of enforcement of the CPSIA testing and certification requirements.  Unless extended by the CPSC, the stay of enforcement will expire about three months from now in February 2010.

Yesterday, the CPSC posted on its website a draft guidance document that explains the two types of certification of compliance required by CPSIA: a general conformity certificate, based on a reasonable testing program; and, for children’s products, a certificate based on CPSC-recognized third-party testing.  Previously, the CPSC has taken the position that the general conformity certification requirement applies broadly to any product subject to a CPCS rule, standard, or ban, including for example any product that requires child-resistant packaging under the Poison Prevention Packaging Act (“PPPA”).  In December 2008, CPSC posted Frequently Asked Questions (“FAQs”) that specifically address how the certification requirement would apply to PPPA products.  

The new guidance document, which has been sent to the Commissioners for their vote, however makes no mention of PPPA products.  The CPSC will hold a public meeting on Monday November 9, 2009 to discuss the document.  We will attend the meeting and report back any significant developments.

By Ricardo Carvajal –

Several Congressional representatives wrote a letter to FDA asking the agency to “fully implement” a provision of the FDCA that allows marketing as a dietary supplement of an article previously investigated for use as a drug.  Section 201(ff)(3)(B)(ii) excludes from the definition of a dietary supplement any article for which an IND was authorized and for which substantial clinical investigations were instituted and made public, unless the article was marketed as a food or supplement before the IND was authorized.  However, the dietary supplement exclusion can be rendered inapplicable to an article by FDA’s issuance of a regulation.  This somewhat cumbersome mechanism allows for the marketing of an article as a supplement even if it was previously studied as a drug.  Although the letter does not reference any specific products, a citizen petition pending with FDA asks the agency to issue a regulation allowing the marketing of homotaurine as a dietary ingredient under the rulemaking authority described above (see our prior post here). 

The Congressional representatives also expresses dismay over FDA’s request for comment on the issue of whether section 301(ll) applies to dietary supplements, given the “the absence of any indication that Congress intended for [section 301(ll)] to replace any existing law.”  For more on issues raised by FDA regarding its implementation of section 301(ll), see our prior post here.