We once saw a sign in a newsroom that said, "Deadlines, schmedlines, as long as I get paid." Maybe Big Pharma has similar signage posted at its various HQs. According to newly released FDA data, drug makers haven't even started more than 1,000 post-marketing studies they promised to do after their products were approved. And some of that research has been in the promised-but-not-started phase for years. Almost 450 have been on the pledge rolls since way back in 2004.
Now, some of that is the FDA's fault; the agency doesn't always set deadlines for this research. And some drug makers are doing their duties. About 16 percent of post-marketing research was on or ahead of schedule and 14 percent had been submitted to FDA or terminated before completion.
What we're wondering, though, is what FDA will do with its new powers to compel those studies, granted by Congress in the agency funding bill last fall. Will FDA start cracking the whip? Will drug makers shift these studies into high gear? We'll be watching the agency's numbers to find out.
- read the item at Pharmalot
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