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Approaches to Decrease the Time Gap Between FDA Approval and the Ability to Market a DEA Scheduled Drug

Track:
Public Policy/Health Care Compliance/Law

Day & Time:
June 18, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
340

Room Number:
6E

Level:
Intermediate

Type:
Session

Title:
Approaches to Decrease the Time Gap Between FDA Approval and the Ability to Market a DEA Scheduled Drug

Chair(s):
Virginia Beakes-Read, BSN, JD
Executive Director, Global Regulatory Policy and Intelligence
Eisai Inc., United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Framework for Pharmaceutical product Scheduling Under the Controlled Substances Act
Lynn W. Mehler, JD
Partner
HoganLovells, United States

A Former Regulators Perspective on Controlled Substance Scheduling
Alan G. Santos
Vice President, Pharmaceutical Compliance and Related Services
Pyramid Healthcare Solutions, United States

The Science of Abuse Liability Assessment: History and Future Challenges
Lawrence Carter, PhD
Director, Clinical Development
Jazz Pharmaceuticals, United States