Federal Regulation in the Absence of Prescription Drug Legislation: The Bush Administration's Proposal to Speed Generics to Market
 
January 31, 2003
 

For the past several years, in response to the growing public demand for affordable and accessible prescription drugs from the seniors lobby and a growing list of other interested parties, the U.S. Congress has attempted, but failed to add a prescription drug benefit to the Medicare program. And while the Executive Branch does not have the authority to create a prescription drug benefit by federal regulation, it can and has taken steps to try to improve access to prescription drugs not only for Medicare beneficiaries, but for all Americans. More specifically, the FDA announced its intention to modify its regulations implementing the Drug Price Competition and Patent Term Restoration Act (P.L. 98-417, 98 Stat. 1585 (1984) (Hatch – Waxman Act). Michael Gaba has written an article that summarizes the FDA's Proposed Rule. It is intended to promote a better understanding of the policy issues as our representatives in Washington engage once again in the prescription drug debate, which necessarily will be informed by the modified regulations implementing the Hatch – Waxman Act.  Read the full article at /id24660/publicationid3/returnid33/contentid45874/.