Review of Annual Meeting 2009
By: Caryn M. Silverman, Esq., Section Vice-Chair, and David S. Weinstock, Esq., Section/Program Chair
View Program Flyer here.
The Food, Drug and Cosmetic Law Section continued its longstanding tradition of having the top lawyers from the U.S. Food and Drug Administration (FDA) and its parent agency, the Department of Health and Human Services, participate as keynote speakers in its Annual Meeting programs. These attorneys and other prominent food and drug practitioners spoke on a variety of topics offering valuable information and insights to food and drug law practitioners regardless of their specific focus. This year's program included panels discussing cosmetics, dietary supplements, preemption, direct-to-consumer and internet advertising and promotion, and pharmacy compounding, as well as a review of FTC activities to promote competition in the pharmaceutical industry. For the first time, the Section provided certain course materials on a DVD as a supplement to the traditional bound course handbook. The meeting was very educational and also provided extensive networking opportunities.
The panels and highlights of the meeting included:
Dietary Supplements: FTC and NAD Claim Substantiation Requirements and an Overview of the FDA cGMP Regulatory Scheme.
Mark Levine, Esq. (National Advertising Division of the Council of Better Business Bureaus), Michelle K. Rusk, Esq. (Federal Trade Commission) and Brad Williams (U.S. Food and Drug Administration) focused their discussions on the interaction between NAD, FTC and FDA as each regulates and enforces laws governing the manufacturing and advertising of dietary supplements. Panelists Levine and Rusk discussed varying aspects and approaches taken to substantiate health-related product claims and Williams, Manager of the Division of Dietary Supplement Programs, led a discussion on the new good manufacturing practice requirements.
Cosmetics Enforcement: Panelists Eugene L. Keogh, Esq. (Coty Inc.) and Jeannie M. Perron, Esq., DVM, (Covington & Burling LLP) focused their discussion on the federal labeling requirements for cosmetics, and FDA's enforcement of these regulations through the issuance of Warning Letters, import alerts and detention orders. Attendees were also educated about the jurisdictional issues pertaining to cosmetics, with the FDA regulating cosmetic labeling and the FTC presiding over cosmetic advertising.
FTC and Competition in the Pharmaceutical Industry: Michael J. Bloom, Esq. (Federal Trade Commission) spoke on the authority and activities of the FTC in reviewing competition within the pharmaceutical industry. His presentation included an overview of the Commission's oversight of brandname/generic patent litigation settlement agreements and corporate merger activity.
FDA's Oversight of Drug and Medical Device DTC Advertising. Bethany J. Hills, Esq. (Hodgson Russ LLP) and Donald E. Segal, Esq. (Alston & Bird LLP) shared with us the regulatory frameworks for drug and device DTC advertising promulgated by FDA and FTC, and PhRMA's Code of DTC Principles. Direct-to-consumer advertising has been increasing in recent years and this discussion also focused on the specific enforcement authority of the agencies, various types of advertisements and claims of misbranding. DTC advertising of devices is currently less regulated although action is afoot seeking stricter policies in that area.
FDA Regulation of Rx Promotion on the Internet: A Tangled Web Roger Thies, Esq. (Hyman, Phelps & McNamara, P.C.) led a timely discussion on the exponential growth of internet advertising and promotion of drug products. In direct response to this huge growth area, FDA has recently stepped up its enforcement of internet promotional activities. While there are no FDA regulations or guidances specifically addressing internet promotional activities, Thies discussed how within the current regulatory framework, FDA has seen fit to regulate internet promotion and shared specific examples of the agency's enforcement activities. As the presenter suggested, we can certainly expect to see greater involvement of the FDA in this area. [Thies kindly substituted for Dara Katcher Levy, Esq. (Hyman, Phelps & McNamara, P.C.) who prepared the printed handout materials and presentation but was unable to attend the Annual Meeting.]
Pharmacy Compounding in Flux: Who Is Doing What: Pharmacies, FDA, Courts? Irving L. Weisen, Esq. (Law Offices of Irving L. Weisen) shared current developments in drug compounding. Weisen discussed the impact of the Food And Drug Modernization Act of 1997 on compounded drugs and touched on the debate whether compounded drugs are considered by the FDA to be "new drugs". Examples where FDA has issue warning letters to compounded drug manufacturers are topical anesthetics, Estriol and bioidentical hormone replacement therapy products.
Drug and Device Preemption: Where are We Now? Preemption has been a hot ticket item for drug and device manufacturers in 2009. This discussion was particularly timely given that the much anticipated drug preemption case - Wyeth v. Levine - was pending before the U.S. Supreme Court at the time of the Annual Meeting. Geoffrey Levitt, Esq. (Wyeth) discussed FDA's ultimate authority over drug labeling; its balancing of risks and benefits in its decision making processes and the drug manufacturer's obligations to report newly obtained safety information. Richard M. Cooper, Esq. (Williams & Connelly LLP) discussed the current status of device preemption as shaped by Riegel v. Medtronic and Medtronic v. Lohr and general principles of express and implied preemption.
A fully packed morning was immediately followed by our keynote luncheon. Daniel Meron, Esq., a partner at Latham & Watkins and the former general counsel of the Department of Health and Human Services, addressed the Section during the luncheon. His discussion "Drug and Device Regulation at the Dawn of a New Political Order: Reflections of a Former HHS General Counsel" was particularly insightful given the challenges which face the new federal administration. Meron provided his thoughts on the future of the FDA, touching on pivotal topics, such as safety problems arising from imported drugs, preemption, healthcare reform, and the expansion of false claims act actions.
Section Chair David S. Weinstock, Esq. (Boehringer Ingelheim Pharmaceuticals) chaired this year's Annual Meeting and at the conclusion, announced the Section's Executive Committee for 2009-2010. As a thank you for the speakers' invaluable participation in making this year's meeting an abounding success, Weinstock presented each presenter with a commemorative mug bearing a likeness of the 1998 stamp issued by the U.S. Postal Service honoring the 1906 Pure Food and Drugs Act.
Mr. Weinstock concluded the meeting by thanking Caryn M. Silverman, Esq., Section Vice-Chair (Sedgwick, Detert, Moran & Arnold LLP), and Annie M. Ugurlayan, Esq. (National Advertising Division of the Council of Better Business Bureaus), for their assistance in identifying and arranging for some of the speakers who participated in Annual Meeting 2009!