FDA may act on anecdotal evidence that some generic drugs don't work as well as their branded counterparts. The agency's CDER chief Janet Woodcock told generics industry folks at a conference that FDA is considering tighter standards for the copycat drugs.
That's because more and more prescriptions are filled with generics these days, since generic versions of blockbuster meds are now available and everyone wants cheaper drugs, and an increasing number of industry types have been telling Woodcock that some generics really aren't equivalent to the branded drugs they're imitating.
"They say, 'I know there are products out there that aren't equivalent,' and typically they're manufacturing folks," Woodcock said in her speech. "I've heard it enough times from enough people to believe that there are a few products that aren't meeting quality standards." Later, she told Bloomberg that FDA is discussing new standards to make sure "there is less variability" among generics.
Trouble is, one of the reasons generic drugs are less expensive is that they aren't required to make it through the same sort of rigorous testing that branded drugs do. Understandably, the industry is a little concerned about what sort of new standards FDA might adopt. But Woodcock's disclosure isn't out of the blue; as Bloomberg points out, an expert panel advised FDA in April that its equivalency requirements aren't good enough for some drugs.
- read the Bloomberg piece