Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products – FDA Watch
In this fourth and final part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Michelle Butler, Director at HPM; Charles Raver, Associate at HPM; and Josephine Torrente, Director at HPM. Together, they discuss potential avenues to resolve a disagreement informally; how the formal dispute resolution (FDR) process works; why companies would engage in the FDR process and what constitutes a win; common misconceptions about the FDR process; what changes may be coming to the FDR process; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guests
Michelle Butler
For more than 25 years, Michelle Butler has provided counsel on FDA law and government pricing for companies with prescription drugs and biologics. Across these practice areas, she specializes in the interpretation of complex regulations.
Butler has worked on a range of regulatory matters, focusing on corporate transactions and counseling on prescription drugs/biologics matters. Her work on corporate transactions frequently involves pharmaceutical and biotechnology companies and includes matters related to financings, including public offerings, mergers and acquisitions, and licensing transactions. She routinely conducts FDA-related diligence, reviews disclosures and agreements, and provides practical advice to assist clients with making acquisition or valuation determinations. Within the area of prescription drugs/biologics counseling, Butler’s practice includes formal dispute resolution and user fee issues, with the latter focusing on PDUFA waivers and exemptions.
Butler also advises clients on calculation and reporting across government pricing programs, specifically the Medicaid Drug Rebate Program, the 340B Program, the Medicare Part B Average Sales Price calculation, and the Veterans Health Care Act’s federal ceiling price restrictions. Butler also advises clients on changes to those programs, as well as relevant parts of the Inflation Reduction Act, and on contracting with the federal government.
Charles Raver
Charles G. Raver assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues. His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations. Raver joined Hyman, Phelps & McNamara after more than a decade in biomedical research spent studying the neurobiological mechanisms of chronic pain and sensory processing. He now leverages his deep knowledge of the drug development ecosystem and background in neuroscience, pre-clinical animal research and study design to help clients navigate the regulatory landscape faced by the life sciences industry.
Raver graduated with honors from the University of Maryland Carey School of Law. While in law school, he served as a staff editor and the first social media chair for the Journal of Health Care Law & Policy. He also received two CALI awards after nabbing the top grade in courses on Animal Law and Written and Oral Advocacy. Throughout law school, Raver continued his neurobiology research career full-time. His research has resulted in nine original peer-reviewed research publications demonstrating potential therapeutic targets for treating chronic pain and revealing functions of neural circuits responsible for sensory processing. Raver also has extensive knowledge and direct experience with the advanced techniques driving development of current biomedical therapies, such as optogenetics, chemogenetics, viral vector-mediated gene delivery, and targeted stimulation techniques.
Josephine Torrente
Josephine Torrente’s practice focuses on bringing promising new drug and biological therapies through the FDA approval process. With more than 30 years of experience in the industry, Torrente provides essential regulatory insight and strategic perspective into the pursuit of aggressive objectives.
Torrente advises biotech and pharmaceutical senior executives and development teams on strategic direction at critical moments in drug development, from preclinical and Phase 1 matters to complex Phase 3 study design issues, and advisory committee preparation. Key to her success is the ability to fully understand and address or challenge FDA concerns at the earliest possible time.
Torrente also routinely leads teams of specialized HPM attorneys in conducting FDA-related diligence, providing practical and actionable advice that help clients make determinations on acquisitions and valuations.
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