Kleinfeld, Kaplan and Becker LLP is proud to announce that partners Scott M. Lassman and Peter R. Mathers are being recognized under FDA Law in the 2013 edition of Washington DC Super Lawyers. Recognition in Super Lawyers depends on the recommendations of other top lawyers, which are then evaluated by a blue ribbon panel of peers within their primary area of practice.
Stacy L. Ehrlich will be moderating the session “Tobacco: Implementing Effective and Reasonable Regulations Following the “Deeming” Regulation — From Good Manufacturing Practices to Tobacco Product Standards.” The FDLI Annual Conference will be held at the Ronald Reagan Building/International Trade Center, 1300 Pennsylvania Avenue NW, Washington, DC on April 23-24. Contact FDLI for more information.
A panel of the U.S. Court of Appeals for the Second Circuit has upheld a New York City ordinance restricting sales of “flavored tobacco products” to tobacco bars only. The decision rejected a federal preemption challenge brought by U.S. Smokeless Tobacco Manufacturing Company LLC and U.S. Smokeless Tobacco Brands, units of Altria Group. The Altria plaintiffs sought relief from the local law, which applies to flavored tobacco products (e.g., smokeless tobacco products) that the federal ban on flavored cigarettes currently does not reach.
Under the challenged ordinance, a “flavored tobacco product” is one that has a constituent that imparts a “characterizing flavor,” which the law defines as “a distinguishable taste or aroma, other than the taste or aroma of tobacco, menthol, mint or wintergreen, imparted either prior to or during consumption.” The ordinance also provides that a tobacco product manufacturer’s statement “that such tobacco product has or produces a characterizing flavor shall constitute presumptive evidence that the tobacco product is a flavored tobacco product.”
In its February 26, 2013, decision, the appeals court affirmed a federal district court’s ruling that the Family Smoking Prevention and Tobacco Control Act (“TCA”) does not preempt the Big Apple’s ordinance.
In summary, the Second Circuit reasoned that:
Whether the Altria plaintiffs will seek review from the Supreme Court of the United States reportedly remains to be seen.
In blessing the ordinance, however, the court may have provided a blueprint to other jurisdictions considering adopting laws aimed at limiting access to tobacco products with characterizing flavors other than cigarettes, which, again, federal law already prohibits. See 21 U.S.C. § 387g(a)(1)(A). For example, the New York State Legislature is considering such a bill, as is St. John’s County, Florida. Providence, Rhode Island, already has a law that survived a multi-pronged challenge before the federal district court there. The tobacco industry plaintiffs in that case have since appealed the decision to the First Circuit.
Only time will tell whether other jurisdictions wait to learn the ultimate fates of the Providence and New York ordinances or risk having to defend their own laws against potential challenges from industry.
Three KKB attorneys are scheduled to speak during “Food Week 2013,” a four-day conference hosted by the Food and Drug Law Institute (“FDLI”). The conference runs from February 5-8, 2013, at the Renaissance Marriott Dupont Circle in Washington, DC.
KKB partners Tony Young and Anne Maher will serve as key presenters during the conference’s two-day “Introduction to Food Law and Regulation” course. For more than 15 years, FDLI has offered this course as a one-stop resource for the essential elements of food law and regulation. On February 5, Ms. Maher will present a lecture titled, “Advertising: The Federal Trade Commission and Private Rights of Action.” On February 6, Mr. Young will instruct attendees on the basics of FDA’s regulation of dietary supplements.
“Food Week 2013” also includes four single-day advanced programs for food law professionals. During the February 7 program on food safety, KKB attorney Will Woodlee will serve as both the moderator and a presenter for a session on FDA’s new and expanded enforcement authorities under the FDA Food Safety Modernization Act. Previously, Mr. Woodlee served as the editor of FDLI’s 2012 publication, The Food Safety Modernization Act: A Comprehensive, Practical Guide to the Landmark Legislation, for which KKB partners Dan Dwyer and Tony Young authored chapters.
Additional information on “Food Week 2013” can be found here.
Imagine that the Federal Food, Drug, and Cosmetic Act (FDCA) is a college freshman, and that the First Amendment is another college freshman. Then imagine that they are both assigned to the same dorm room. Will they peacefully coexist? Will they like and support each other? Or will they develop a pathological distrust and spend their time trying to sabotage each other?
A recent court decision suggests that “distrust” might characterize this relationship. The decision is United States v. Caronia, Docket No. 09-5006-cr (2d Cir. Dec. 3, 2012). In this blog entry, we discuss what this decision may mean and whether it has any implications for food labeling law.
United States v. Caronia
In United States v. Caronia, the court reviewed the conviction of a pharmaceutical sales representative, Mr. Caronia, for conspiracy to introduce a misbranded drug into interstate commerce. The conviction had been based on Mr. Caronia’s promotional statements about off-label use of the drug.
In the majority opinion, the court distinguished between two distinct functions that promotional statements may have under the FDCA: (1) promotional statements as evidence of intended use, and (2) promotional statements as per se misbranding.
The government contended that it prosecuted Mr. Caronia only under function (1). That is, according to the government, Mr. Caronia’s statements functioned solely as evidence of how he (and his employer) intended the drug to be used. Based on such evidence, the drug had intended uses beyond the use covered by FDA’s approval, and therefore the government took the position that the drug was not labeled with adequate directions for the off-label uses and was misbranded.
The court, however, looked closely at the government’s approach to the case and concluded that Mr. Caronia’s conviction rested on function (2). Specifically, the government “repeatedly argued that Caronia engaged in criminal conduct by promoting and marketing the off-label use of Xyrem, an FDA-approved drug.” Slip op. at 28. In other words, “the government has treated promotional speech as more than merely evidence of a drug’s intended use — it has construed the FDCA to prohibit promotional speech as misbranding itself.” Id. at 10.
The court seems to be saying that, if speech is to be used as evidence of intent, it must be analyzed as evidence. That is, its evidentiary strength must be weighed and a conclusion reached about the intended use of the drug based on that weight. If the evidence is adequate to establish intended use, then a misbranding charge (based on lack of adequate directions for use) might apply. However, the court appears to be saying that the government cannot simply assume that, because there has been promotion for an unapproved use, the drug is necessarily misbranded.
In particular, the court highlighted the fact that this was a criminal violation. Indeed, the court observes that, where criminal charges apply, “even more careful scrutiny is warranted.” Slip. op. at 34. The government cannot analyze Mr. Caronia’s speech as constituting misbranding by itself, the court says, because this would be inconsistent with the First Amendment.
The court leaves open the possibility that the government might, in some future case, use a defendant’s speech as evidence of the intended use of a drug. The court says, for example, “Even assuming the government can offer evidence of a defendant’s off-label promotion to prove a drug’s intended use and, thus, mislabeling for that intended use, that is not what happened in this case.” Id. at 27-28. The words “even assuming” seem a little skeptical about whether that assumption is valid … but the court does not decide this issue one way or the other.
Importantly, in leaving open the possibility of analyzing speech as evidence of intended use, the court seems to be laying the groundwork for future decisions in which it might analyze whether some types of speech about off-label uses do or do not create a new intended use.
The dissent disagrees that the government prosecuted Caronia for his speech and argues that, in fact, the government used Caronia’s speech only as evidence of intended use. Moreover, the dissent “fail[s] to see how the majority’s reasoning would ever allow such speech to support a conviction ….” Dissenting slip op. at 8. The dissent goes on to say that, under the majority opinion, “a mislabeling charge simply may not rest on off-label promotion.” Id. at 12. As discussed above, however, it may be possible to read the majority’s opinion more narrowly.
Does Caronia have any Implications for Food Labeling Law?
The short answer is “yes,” though indirectly.
As discussed above, Caronia can be read as applying narrowly only to a situation where –
Even this narrow interpretation, however, indicates the Second Circuit’s willingness to subject a law to “heightened scrutiny” if it disfavors certain speech (e.g., marketing) and certain speakers (e.g., pharmaceutical companies). In this regard, Caronia relies heavily on Sorrell v. IMS Health Inc., 131 S.Ct. 2653 (2011).
In Sorrell, the Supreme Court evaluated a Vermont statute that prohibited the use of prescriber-identifying information for pharmaceutical marketing. The statute thus disfavored speech with marketing content and disfavored specific speakers, namely pharmaceutical manufacturers. Citing Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980), the Supreme Court said that this approach required heightened scrutiny and that it was invalid because, at a minimum, under a commercial speech inquiry, the state did not meet its burden of showing that the statute directly advances a substantial governmental interest and that the measure is narrowly drawn to achieve that interest. In doing so, the Court said:
(Internal quotations and citations omitted.)
How do the requirements of the FDCA governing nutrient content claims and health claims for foods fare under the principles of Caronia and Sorrell discussed above?
Point 4 above is consistent with the approach in Whitaker v. Thompson, 353 F.3d 947 (D.C. Cir. 2004), which held that the use of speech to infer intended use under the FDCA is constitutionally valid. The D.C. Circuit explained that the First Amendment allows “the evidentiary use of speech to establish the elements of a crime or to prove motive or intent.” Id. at 953 (citation omitted). The speech at issue in Whitaker represented a dietary supplement for use in the treatment of an existing disease and the court concluded that this type of speech could be used to infer intended use as a drug. However, the court did not suggest that all health claims for foods necessarily imply intended drug use. In fact, it is possible that a health claim for a food might be made in a way that does not imply that the food is intended for use as a drug.
Consider the following hypothetical claims for foods:
So long as these claims are truthful and not misleading and do not, in context, suggest that the food is intended for use as a drug, they might arguably be protected under the First Amendment, even if they are inconsistent with the FDCA.
Ultimately, like most college roommates, the FDCA and the First Amendment can probably learn to peacefully coexist – even if there will always be some tension between the two.
On December 12, the Food and Drug Law Institute (FDLI) held its Annual Holiday and Leadership Awards Reception. KKB is proud to announce that partner Thomas O. Henteleff received FDLI’s Distinguished Service and Leadership Award. Since 1993, the organization has bestowed this honor to recognize:
In light of his 43 years of practicing food and drug law, and his decades-long service to FDLI, Mr. Henteleff could have qualified for the award on any one of these bases.
Mr. Henteleff is the second KKB partner to receive the award, joining founder Alan H. Kaplan (1994 recipient) in this distinguished group of food and drug law community leaders. (At FDLI’s 1981 annual meeting, founder Vincent A. Kleinfeld received what could be described as a predecessor to the Distinguished Service and Leadership Award.)
KKB congratulates Mr. Henteleff on this much-deserved honor. KKB also wishes to congratulate the three other 2012 recipients:
Late last month, the Massachusetts Department of Public Health (“MDPH”) approved emergency regulations implementing, among other things, required changes to the meal provisions of the state’s Pharmaceutical and Medical Device Manufacturer Code of Conduct (“Code”). An appropriations bill signed by Governor Patrick over the summer—HB 4200—mandated a repeal of the Code’s ban on providing restaurant meals to health care practitioners as part of non-CME informational presentations. Since the Code became law in 2009, companies could offer meals during such presentations but only in a health care practitioner’s office or a hospital setting.
HB 4200 amended the law to require MDPH to revise the Code to allow drug and medical device manufacturers to provide or pay for “modest meals and refreshments in connection with non-CME educational presentations for the purpose of educating and informing health care practitioners about the benefits, risks and appropriate uses of prescription drugs or medical devices, disease states or other scientific information.” However, such presentations must occur “in a venue and manner conducive to informational communication.” The statutory changes also require the agency to define “modest meals and refreshments” and require covered companies that provide such meals to comply with quarterly reporting requirements.
MDPH’s emergency regulations took effect September 19. Notably, the Code now:
While these changes have already taken effect, MDPH has announced an October 19 public hearing to receive testimony on the emergency regulations. Interested parties may submit written testimony/comments by 5:00 p.m. EST on October 26. It appears that MDPH will post all written testimony/comments received here.
We expect that many stakeholders will weigh in on the emergency regulations’ somewhat unhelpful definition of “modest meals and refreshments.” The current definition indicates that MDPH will judge modesty based on whether the meal is “similar to what a health care practitioner might purchase when dining at his or her own expense.” Similar to a meal a practitioner might purchase where? At the presentation’s venue? And when? At lunch on a workday, for dinner on a weekend evening, or on a special occasion? The definition could also create problems when the health care practitioner attendees of a given presentation include a variety of professionals with a wide range of incomes. It remains to be seen whether companies will wait to resume offering restaurant meals during speaker programs until MDPH issues final regulations, including a more-workable “modest” standard.
Kinsey S. Reagan is giving a presentation on Agricultural Use of Antibiotics in Animals at American Conference Institute’s FDA & USDA Compliance Boot Camp in Chicago, IL, on October 4, 2012.
Daniel R. Dwyer and Stacy L. Ehrlich are giving a presentation at the American Conference Institute’s “Legal and Regulatory Compliance Forum on OTC Drugs,” October 18-19, 2012, in New York, NY.
James William Woodlee (“Will”) will be giving a presentation on “The Regulatory Aspect of FSMA” and Anthony L. Young will be giving a presentation on “FDA Enforcement Reality Check” at the Supply Side West Global Expo and Conference on November 5-9 in Las Vegas, NV.
Will Woodlee also published an article entitled “How the FDA Food Modernization Act Responds to Terrorism Threats: A Primer” in the September issue of Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science.
Kleinfeld, Kaplan, and Becker LLP (KKB) won a victory on behalf of its client, Stat-Trade, Inc., in a lawsuit against the Food and Drug Administration (FDA) challenging the improper assessment of user fees under the Prescription Drug User Fee Act (PDUFA). On June 25, 2012, the United States District Court of the District of Columbia granted (in part) Stat-Trade’s summary judgment motion, ordered FDA to refund fees collected for fiscal year 2012 for two of Stat-Trade’s prescription drug products, and permanently enjoined the Agency from assessing fees on those products in the future.
The case stems from a dispute over FDA’s assessment of PDUFA product fees for two strengths of Naprelan® (naproxen sodium) controlled-release tablets, Stat-Trade’s prescription, non-steroidal anti-inflammatory drug. Although the two Naprelan® products were subject to generic competition for nearly seven years – during which time they were exempt from product fees under the so-called “ANDA Exception” – FDA began assessing fees anew when the generic competitors were removed from the market following patent litigation. FDA took the position that the ANDA Exception applies only if a drug product faces active generic competition. Significantly, this interpretation conflicts with a guidance document issued by FDA in 1994, which provides that the marketing status of a generic is not relevant for purposes of the ANDA Exception.
After reviewing cross-motions for summary judgment, the District Court rejected the FDA’s new interpretation of the ANDA Exception. The Court held that FDA’s interpretation fails under step one of the well-known Chevron test because it conflicts with the clear statutory language of PDUFA. According to the Court, the ANDA Exception is unambiguous and is triggered if a generic product is approved, regardless of its marketing status. Moreover, the Court stated that even if it were to reach Chevron step two, it nevertheless would reject FDA’s interpretation as unreasonable. The Court explained that, given the informality of FDA’s decision-making process, the Agency would not have deserved full Chevron deference, but only the weaker Skidmore deference, and that the Agency’s rationale could not justify its interpretation of the ANDA Exception under either standard. We note that the ANDA Exception was amended after the Court’s decision by the Food and Drug Administration Safety and Innovation Act (Pub. L. No. 112-144).
The Court’s grant of summary judgment builds upon KKB’s earlier, successful efforts to force FDA to refund fee amounts from prior fiscal years. In particular, in October 2011, KKB filed a motion for preliminary injunction seeking an immediate refund of certain fees from fiscal years 2009, 2010, and 2011. Before the Court could rule on the motion, however, FDA acquiesced to KKB’s demands and agreed to waive a significant amount of fees from prior fiscal years. The KKB litigation team included Scott M. Lassman, James “Will” Woodlee, and Cynthia L. Meyer.
Key Words: PDUFA, user fee, ANDA Exception, Stat-Trade, FDA, lawsuit, summary judgment, injunction, refund, court, product fees
KK&B congratulates its Managing Partner Thomas O. Henteleff for again being recognized under FDA Law in the 2012 editions of Washington DC Super Lawyers and in The International Who’s Who of Life Sciences Lawyers. Recognition in Super Lawyers depends on the recommendations of other top lawyers, which are then evaluated by a blue ribbon panel of peers within their primary area of practice. Recognition in The International Who’s Who of Life Sciences Lawyers is based on the opinions of law firm clients and life sciences lawyers from around the world.
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