According to a Bloomberg story quoting Janet Woodcock, director of the FDA's CDER, the agency is considering tighter standards for generics. Why this is the case is not exactly clear to me. In the article, Woodcock refers somewhat cryptically to alleged comments purportedly from patients and unnamed employees of generic manufacturers that say some generics "don't work as well as the originals".
Hmmm. The employees are unnamed. The companies they work for are unnamed. The drugs in question are unnamed. The basis for "don't work as well" claim is unsupported with data or specifics. There seemed to be some innuendo aimed at anti-seizure drugs though.
Woodcock made her statements at a meeting of the Generic Pharmaceutical Association. I speculate she was delivering a message to someone - certainly Miles and Sandoz sat up and took notice. Maybe they are supposed to help police some of their members? PhRMA of course also took notice and the opportunity to state the FDA must keep us safe by ensuring generics are safe.
David Rosen, an attorney at Foley & Lardner LLP in Washington who served as a top-level generic official at FDA between 1980 to 1989, said questions have long been raised about generic compounds’ effectiveness based on anecdotal evidence. He wondered what is different now.
Nothing. Just more sabre rattling by FDA.
Woodcock said she didn’t know when the agency would come to any conclusions about generic standards of equivalence. The standards assure the generic is absorbed at the same rate and extent as the brand-name version.
The absorption problems aren’t necessarily harmful, Woodcock said. FDA permits generic drugs to absorb at a 25 percent different rate and extent than the originals they copy. Australia, Canada, the European Union, Japan and South Africa have stricter bioequivalence standards for critical dose drugs. Woodcock also urged generic-drug makers to put more emphasis on “product presentation.”
“Manufacturers need to think beyond therapeutic equivalence,” Woodcock said. Why, if that is what the regulations emphasize? If you want different emphasis, add to or emend the regs - preferably in public forum with commentary.
Truth, Justice and the American Way!
Posted by Bruce Lehr October 24th 2010