If there's a silver lining in the heparin cloud, it could be this: Suddenly, the FDA asking for more moneyÂ to fund overseas inspections isn't just a theoretical or precautionary measure. When Center for Drug Evaluation and Research honcho Janet Woodcock told Congress Wednesday that the FDA needed to beef up foreign oversight, reps quickly connected that call to the agency's failures vis-Ã -vis heparin.
They also appeared eager to give Woodcock what she wanted--at least while speaking publicly. (It didn't hurt that this gave the opportunity for Democrats to bash the Bush administration for cutting foreign-inspection funding since taking over.) They pressed her to say how many more inspectors would be needed. She couldn't specify, but did say that not only staffers but better computer tracking systems were needed.
Meanwhile, the House Committee on Energy and Commerce released ambitious funding numbers for the agency, generated by members and advisors to the FDA's Science Board. Criticizing the Bush budget, Reps. John Dingell and Bart Stupak said the agency needs an funding increase nine times the figure the president has proposed. Whether any of this posturing actually translates into real dollars remains to be seen.
- see the Associated Press article
- read the press releaseÂ from Energy and Commerce
FDA chief admits need for funding, reform. Report
The FDA: Caught between a rock and a hard place. Report
Agreed in committee: FDA needs money. Report
FDA badly needs more money, staff.Â Report
FDA can't guarantee drug safety. Report