The Senate overwhelmingly passed the drug-safety and FDA funding bill yesterday and sent it along to President Bush for his signature. Experts are calling it a sea change in the FDA's operations. Instead of waiting for reports of adverse events to roll in, the agency will be on the prowl for evidence--digitally, through its new surveillance system and clinical trials database, and non-digitally, by ordering post-approval trials. Questions: Will the agency figure out how to separate false alarms from real read flags? Can it target its post-approval trials appropriately? There's nothing to do but watch and wait.
Interestingly, the final version of the bill is a bit toothless when it comes to regulating drug ads. Apparently, the media industry helped pharma fight provisions that would have allowed the FDA to force changes in direct-to-consumer advertising. Now, the agency will only be able to recommend them.
- read the analysis in the Los Angeles Times
- read this Wall Street Journal article on the media's pro-DTC lobbying
House overhauls, passes PDUFA. Report
FDA: 2,000 layoffs if PDUFA not passed. Report
Bickering may stall trial database. Report
10 reforms for drug advertising. Report
Does the FDA do enough to regulate drug ads? Report