Volume 2

Reform of Drug Regulation – An NEJM Sounding Board Article

Reform of Drug Regulation

by W. A. Ray and C. M. Stein, NEJM, January 12 2006, Vol 354(2)

Recent withdrawals of high-profile drugs highlight the limitations of drug regulation by the FDA and safety testing by the pharmaceutical industry. Conflicting interests of manufacturers and the FDA afflict the current system. To avoid “drug disasters,” the authors propose increasing the availability of post-marketing data, curtailing the influence of manufacturers on drug release, and raising physician awareness of all available drug data.