An Evolving Direction for Drug Oversight – FDA Watch
Wayne chats with Brian Malkin, Partner at Spencer Fane. You’ll hear Brian’s thoughts on potential FDA leadership under Heidi Overton, early priorities for drug and biologics companies, implications for drug pricing, AI in drug development, new approach methodologies and the shift away from animal testing, sponsor use of NAMs in place of traditional animal studies, skinny labeling, and implications for generic drugmakers, overlooked and emerging FDA issues for pharma and biotech companies, and much more.
Headlines
FDA announces broad recruitment effort to expand range of people on advisory committees
Pharma: FDA launches expedited Investigational New Drug (IND) pilot program
Devices: AI and robotic surgery among FDA’s top areas of focus in FY27 guidance priorities
Food: PepsiCo recalls over 122,000 cases of Gatorade after bottles were found to contain undisclosed Yellow No. 5 and/or Yellow No. 6
Cosmetics: FDA informs cosmetic product facilities and retailers that the agency does not provide certificates to verify compliance for cosmetic product facility registration
About Our Guest
Brian Malkin
Brian Malkin streamlines processes for clients navigating the complex intersection of patent law and food and drug law, leveraging unique public and private sector experience, in-depth creative and strategic analysis, and advanced negotiation tactics to meet and exceed stakeholder expectations.
This skill set is evident across Brian’s focus areas, which include U.S. Food and Drug Administration (FDA) and patent litigation for FDA-regulated manufacturers and pharmacies, patent prosecution for life sciences companies, and robust regulatory counsel for products spanning human and animal drugs and biologics, medical devices, foods and dietary supplements, tobacco products, and cosmetics. His practice also includes wellness products and emerging areas such as artificial intelligence (AI)-enabled or generated products and regenerative medicine as well as state-regulated products such as cannabis and psychedelics.
Boasting more than three decades of regulatory experience, Brian spent nine years as regulatory counsel at the FDA Office of the Commissioner and the Center for Drug Evaluation and Research. After returning to university to obtain a bachelor’s degree in biochemistry and passing the USPTO Bar, he then served as FDA and intellectual property (IP) counsel for several boutique and international law firms for more than two decades. Most recently, he served as associate general counsel – regulatory in the IP Department at Teva Pharmaceuticals. Since joining Spencer Fane, he created and now leads the FDA Pharmaceutical and Biologics Market Team and continues to develop additional FDA and life sciences focus areas for the firm.
Brian uniquely combines these viewpoints to effectively guide clients through the entire product life cycle. This includes leading product financing and development, negotiating and drafting agreements, obtaining approvals, enforcing IP protection, implementing regulatory affairs strategies and leadership, conducting due diligence, and managing associated risks. For example, acting as a regulatory consultant, he has supported clients in obtaining and representing companies in FDA meetings; however, as an attorney, his persuasive arguments and negotiation skills have proven effective to streamline or resolve stalled product development. Also, unlike a regulatory consultant, Brian has navigated attorney-client and work product privileges as appropriate to help develop strategies and regulatory responses for clients.
Outside of his practice, Brian has served as an adjunct professor at Yeshiva University’s Katz School of Science and Health since 2018, where he developed and teaches a course called “Intellectual Property, Regulation and Compliance for Biotechnology.” He has also been a guest lecturer at Georgetown University Law Center since 2018 and American University’s Washington College of Law since 2020, where he teaches courses on global drug law and biologics, health law, and associated regulation. In addition, he has served as a recognized thought leader at dozens of professional conferences and training programs as well as authored articles in leading industry publications, strategically shaping current and future conversations surrounding pharmaceuticals and biotechnology as well as medical devices and the full spectrum of FDA-regulated products.
