DeLauro: Industry Influence Stronger than FDA Authority over Post-Market Drug Studies

DeLauro: Industry Influence Stronger than FDA Authority over Post-Market Drug Studies

- 65% of required post-market studies still pending -

WASHINGTON, D.C. - Congresswoman Rosa L. DeLauro (Conn.-3) today questioned the authority of the Food and Drug Administration (FDA) to pursue post-market studies of drugs already on the market. According to FDA's annual report, as of September 30, 797 of the 1, 231 post-market studies the agency called for are still pending - a total of 65%. Most post-market studies are agreed to by the drug maker as a condition of drug approval.

"With 65% of post-market studies pending this years, with a period of 14 months passing before the label on Vioxx bottles changed, and with 5 years passing before an animal antibiotic was withdrawn because of the company's challenge, one thing is clear: the system is broken and FDA's authority is being called into question. The latest numbers of pending post-market studies prove drug companies will not voluntarily submit to these reviews without proper FDA authority. FDA must have the power to mandate these studies. At this point, industry influence is stronger than FDA authority over post-market drug studies."

http://www.house.gov/delauro/press/2006/March/FDA_industry_3_6_06.html