Hatch–Waxman at 40: A Critical Examination of its Past and Future

DAVID L. ROSEN is partner and public policy lawyer with Foley & Lardner LLP in the firm’s Washington, D.C. office. With backgrounds in pharmacy and law, and 14 years of regulatory experience at FDA, clients rely on David Rosen’s nearly five decades of knowledge when seeking strategic guidance on FDA submissions, compliance, advertising, and enforcement.
At FDA, David progressed to various supervisory positions involving virtually all aspects related to the drug approval process, combination products, jurisdictional issues, and related compliance activities. He authored the FDA’s Orange Book (Approved Drug Products With Therapeutic Equivalence Evaluations), which identifies drug products approved by FDA on the basis of safety and effectiveness under the Federal Food, Drug, and Cosmetic Act; and was instrumental to the development and implementation of the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act), as well as FDA’s Accelerated Approval regulations for new drugs. He utilizes this insider perspective to assist clients within all FDA-regulated industries respond to warning letters and FDA 483 observations, write FDA meeting requests for pre-IND and 505(b)(2) products, and interact with FDA to facilitate product review and approval. He is a recognized leader in virtually all aspects related to the drug and medical device approval/clearance processes, combination products, and jurisdictional issues.