Washington Report: The Little Fix - Pharmaceutical Executive


Washington Report: The Little Fix
Critics want big changes at FDA—but there might be a better way.

Pharmaceutical Executive

Pharmaceutical companies say they are posting more research data voluntarily, but observers contend that a specific mandate is needed to gain full access to important safety information.

Increase FDA resources Patient advocates feel that FDA's budget is too lop-sided, with most resources devoted to new drug approvals and too little to post-approval monitoring. The Administration's budget plan for 2006 proposes to expand funding for drug safety surveillance. However, that amount is still far below the levels needed to conduct all the proactive safety analyses and epidemiological studies that safety experts say are necessary.

Seeking Delay FDA is lobbying for Congress to hold off on legislative change until the agency has a chance to see if new initiatives will address these problems. FDA is establishing a drug safety oversight board to provide an objective perspective on the safety of drugs. A new grievance process will provide a forum for dissenting FDA scientists to air their concerns. The latest drug safety information will be posted on FDA's new Drug Watch website to prevent delays between FDA learning about a safety problem and the information reaching the public, as occurred with Vioxx.

FDA also has finalized three draft guidances on managing the risks in medical products. And the Institute of Medicine is beginning work on a review of the drug approval process, which should examine all these issues over the next two years.

Critics contend that the safety board and website are just window-dressing and will lack the teeth needed to address serious safety problems. Meanwhile, more legislative proposals are likely to surface, and more inquiries will be launched. The main fear among FDA leaders is that poorly designed legislation might jeopardize risk-taking in the drug development process just as more innovative research methods and cutting-edge analytical approaches are emerging.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent.


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