Jeffrey N. Wasserstein
Jeffrey N. Wasserstein focuses on pharmaceutical and medical device promotion, as well as health care fraud and abuse. He also provides counsel on health privacy (HIPAA) and general food and drug law, specializing in the intersection of FDA and health care law. Mr. Wasserstein is a member of several promotional review committees of pharmaceutical and medical device companies. In these roles, he evaluates promotional materials and conducts internal audits of marketing and promotional practices, develops standard operating procedures and policies, and provides training to legal, regulatory, and marketing departments. Mr. Wasserstein also advises on the marketing and promotion of in vitro diagnostic devices.
Mr. Wasserstein is the co-founding blogger of the FDA Law Blog, the industry's foremost resource for insight on food and drug regulation and enforcement actions. He is widely regarded as an industry thought leader in the use of social media to market regulated products that fall under the purview of FDA and the FTC: pharmaceuticals, biotech, medical devices, as well as foods and supplements. Mr. Wasserstein authored a chapter on social media, "Using Social Media in FDA-Regulated Industries: The Essential Guide," FDLI, 2010. He also advises an online publisher on social media best practices with regard to regulated industries.
Mr. Wasserstein practiced in the areas of food and drug and health care law before joining the firm in 2000. Before entering private practice, he clerked for the Honorable Samuel A. Alito, Jr. of the U.S. Court of Appeals for the Third Circuit and the Honorable Allyne R. Ross, U.S. District Judge for the Eastern District of New York.
Advertising and Promotion
• Provides counsel on social media platforms across all regulated products and devices, reviewing content, developing policies, and conducting training.
• Provides the regulatory legal function for small companies, and gives higher-level advice to large companies with well-established legal departments.
• Advises clients on privacy issues (HIPAA) with regard to marketing programs and on clinical trial issues relating to patients' protected health information.
• Provides counsel on fraud and abuse issues for marketing and promotional programs, contractual relationships with third party payers and pharmacy chains, and consulting agreements.
• Reviews programs to ensure compliance with the PhRMA Code on Interactions with Health Care Professionals.
• Provides counsel to clients on Sunshine Act compliance, as well as state gift, marketing, and disclosure laws.
In Vitro Diagnostic Devices
• Advises on appropriate marketing and promotion for in vitro diagnostics.
• Provides counsel on requirements for research use only (RUO) and investigational use only (IUO) status.
• Provides guidance on laboratory-developed tests (LDTs).
• Conducts training for in-house legal and regulatory departments and marketing and sales teams on compliance and regulatory issues.
• Trains lawyers at smaller companies on fraud and abuse, as well as FDA promotional issues.
Awards & Recognition
• The International Who's Who Legal Directory, Life Sciences, Regulatory Section, 2015-2016
Articles / Publications
see more articles
• Amarin Case Tests Limits of FDA Regulation of Off-Label Promotion,
October 1, 2015
• Application of Health Care Fraud and Abuse Laws to the Marketing of Pharmaceuticals and Medical Devices,
January 5, 2014
• Using Social Media in FDA-Regulated Industries: The Essential Guide,
• Court Empowers Qui Tam Defendants To Sue Third Parties For Indemnification,
February 26, 2010
• Application of Health Care Fraud and Abuse Laws to Pharmaceutical Marketing,
see more speaking engagements
• Real-World Implications of United States v. Caronia, January 31, 2013
• 54th Annual FDLI Conference, Our Hearts are a-Twitter: Social Media and Therapeutic Products, April 5 - 6, 2011
• ACI 9th Expert Regulatory Guide to Advertising, eMarketing and Promotions for the Pharmaceutical Industry Conference, Fear Not Pharma: Revolutionizing Your Marketing Strategies to Adapt to Social Media Platforms, March 14 - 15, 2011
• CHPA Regulatory and Scientific Conference, Social Media, May 14, 2010
• FDLI Annual Conference, Social Media, April 23, 2010
see more blog entries
• OIG Issues an Advisory Opinion on Providing Replacement Product,
August 28, 2017
• Not Dead Yet – OPDP Issues Two Untitled Letters Late in the Year (Our 3,000th Post!),
December 18, 2016
• How Will FDA Under @realDonaldTrump Regulate Speech?,
December 6, 2016
• The Seventh Circuit Rejects First Amendment Protection for Commercial Speech Related to an Unapproved Product,
July 14, 2016
• First the Courts, Now Congress… House Committee Throws its Weight Behind Evolving Legal Landscape of Off-Label Promotion,
June 1, 2016