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Approaches to Decrease the Time Gap Between FDA Approval and the Ability to Market a DEA Scheduled Drug
Session Chair(s)
Ginny Beakes-Read, BSN, JD
VP, Global Regulatory Policy, Johnson & Johnson Innovative Medicine, United States
When FDA approves a drug with abuse potential that needs to be scheduled by the Drug Enforcement Administration (DEA), sponsors may not market the drug until DEA scheduling is complete, which can take a year. FDA, DEA, and others must find a way to ensure patient access to new therapies. This session will explore ways for sponsors to work with FDA and DEA to facilitate the scheduling process, including changes that could be made to the process, regulations, or legislation.
Learning Objective : Identify issues associated with Drug Enforcement Agency (DEA) scheduling of new drugs with abuse potential; Describe possible approaches to allow for timely DEA scheduling of drugs so that they may be marketed and available for patients upon FDA approval.
Speaker(s)
Lynn W. Mehler, JD
Partner, HoganLovells, United States
Framework for Pharmaceutical product Scheduling Under the Controlled Substances Act
Alan G. Santos
Vice President, Pharmaceutical Compliance and Related Services, Pyramid Healthcare Solutions, United States
A Former Regulators Perspective on Controlled Substance Scheduling
Lawrence Carter, PHD
Director, Clinical Development, Jazz Pharmaceuticals, United States
The Science of Abuse Liability Assessment: History and Future Challenges
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