Getting it Right on Drug Safety: FDA Makes its Case
This article was originally published in RPM Report
FDA has become everyone's favorite punching bag. But the agency's elder statesman says FDA is getting it right when it comes to the issue of drug safety.
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The chair of the Institute of Medicine drug safety committee, Sheila Burke, agreed to an interview with The RPM Report on about issues related to the Food & Drug Administration's approval process and the debate on Capitol Hill over proposed legislation. Here are excerpts of the conversation.
FDA will have new money and new authority before the year is out. But translating the new drug safety reforms into practice will be the responsibility of some old hands, including the Robert Temple, the dean of FDA's drug review group. The question drug companies should have: What is he thinking?
The time has come when the pharmaceutical industry will have to answer for Vioxx. Congress will address drug safety in 2007. That means FDA could get new authority over the heart and soul of any new drug-the label.