Alan’s practice concentrated on issues concerning products regulated by the Food and Drug Administration. For more than 25 years, he was recognized as a leading expert on FDA’s rules and policies on pharmaceutical advertising and promotion, and has been a frequent speaker and author on the subject. He also had extensive experience on issues involving the Hatch-Waxman Act, product lifecycle management, and the intersection of IP law with the Federal Food, Drug and Cosmetic Act, and is the author of The Legislative History of the Drug Price Competition and Patent Term Restoration Act. In addition, Alan counseled and advised numerous clients on the regulation of biological products, including biosimilars, food additive approvals, and Rx to OTC switches.
Alan began his legal career in the Office of the General Counsel of the Food and Drug Administration, where he was a trial and appellate lawyer and legal advisor to several FDA bureaus. Subsequently he was legislative assistant to the late Senator Jacob Javits and Special Counsel to the Senate Governmental Affairs Committee, where he concentrated on a wide variety of regulatory matters, consumer protection and administrative law issues. After leaving the Hill, Alan co-founded a food and drug boutique firm that was ultimately known as Bennett, Turner and Coleman, which merged into Ropes & Gray in 2002.
Alan is also a former co-chair of Ropes & Gray’s life sciences practice group and former office managing partner for the firm’s Washington office.
- Co-leader of the Medical Information Working Group (MIWG), a coalition of more than a dozen pharmaceutical and device manufacturers, interested in seeking changes to FDA’s rules and policies governing the dissemination of truthful, non-misleading scientific information.
- On behalf of the MIWG, co-author of two citizen petitions and related documents urging specific changes in the way FDA regulates manufacturer speech.
- Participated in the preparation of amicus briefs in the Caronia and Amarin cases for MIWG.
- Led discussions with FDA for several clients in situations where ability to use promotional materials was unclear, and obtained favorable results.
- Prepared several successful citizen petitions to FDA on behalf of innovator pharmaceutical manufacturers regarding appropriate standards for bioequivalence and “sameness” for potential generic entrants.
- Provided Hatch-Waxman advice to assist litigators in an extremely complex ANDA patent litigation.
- Conducted internal investigations of marketing practices in response to whistleblower complaints.
- Assisted two major manufacturers during Congressional consideration of biosimilars legislation.
- Helped draft compliance standards on numerous topics involving off-label dissemination and anti-kickback standards for several companies.
- Quoted, “FDA Off-Label Policy Under Fire: Court Rulings Pile Up, House E&C Floats New Bill,” RPM Report (June 3, 2016)
- Quoted, “F.D.A. Deal Allows Amarin to Promote Drug for Off-Label Use,” The New York Times (March 8, 2016)
- Quoted, “Vascular Solutions, CEO Found Not Guilty in Off-Label Case,” Bloomberg BNA’s Pharmaceutical Law & Industry Report (March 2016)
- Quoted “Amarin Wins Off Label Ruling Against FDA,” The Wall Street Journal (August 7, 2015)
- Quoted, “Court Forbids FDA From Blocking Truthful Promotion of Drug,” The New York Times (August 7, 2015)
- Quoted, “Attorneys Offer ‘New Model’ for FDA Regulation of Off-Label Promotion,” FDA Week (July 2015)
- Co-author, “Back to first principles: a new model for the regulation of drug promotion,” Journal of Law and the Biosciences (April 2015)
- Douglas Hallward-Diemeier and Alan Bennett, “The significant implications of the Carina off-label promotion decision for US FDA-regulated firms,”Scrip Regulatory Affairs (March 2013)
- “Manufacturer Sponsored Speech” - Drug Information Association Medical Affairs Forum, presentation, March, 2016
- “Communication of Scientific Information: the Regulatory Landscape” - Drug Information Association Annual Meeting (presentation, June 2014)
- “FDAMA 114 Guidance” - ACI Health Outcomes and Data Communications Conference (presentation, January 2015)
- “Impact of Caronia on Preapproval Communication” – Drug Information Association (presentation, February and June 2013)
- “Marketing Pharmaceuticals 2011: Workshop for Regulatory Professionals and Promotional Review Teams” – Drug Information Association (presentation, February, 2011)
- “Dissemination of Off-Label Scientific Information” – National Organization for Rare Diseases (presentation, Q4 2010)
- “The United States Opens the Door to Follow-on Biologic Products: Understanding the Benefits and Challenges of the Biosimilars Act” – also with J. Steven Baughman (Partner), Anita Varma (Partner), and James S. DeGraw (Partner) – Ropes & Gray Webinar Series for Clients in Japan (webinar, July 2010)
- “Off and Running: What Biosimilars Legislation Means for Your Company” – together with Bruce S. Manheim, Jr. (Partner) – Ropes & Gray Client Seminar (June 2010)
- “New Decade, New Challenges: The Potential for Major Changes in Promotional Regulation” – 2010 BIO International Convention (presentation, May 2010)
- “FDA Regulation of Social Media” – Ropes & Gray Client Webinar Series (webinar, November 2009)
- “Advertising and Promotion” – Food and Drug Law Institute Conference (presentation, September 2009)
- “FDA Regulation of Drug Promotion” – 2009 BIO International Convention (presentation, June 2009)
- “FDA Regulation of Social Media” – Global Prairie Public Relations (presentation, May 2009)
- “Basic Hatch-Waxman Law” – Food and Drug Law Institute (presentation, February 2009)
- “Hot Topics in Advertising Regulation” – Drug Information Association (presentation, February 2009)