When Cephalon asked the FDA to expand the use of its opioid painkiller Fentora, did it see the shape of things to come at the agency? In Vivo says yes, the "challenging" regulatory environment was on display during last week's advisory committee meeting. In fact, the drugmaker may have faced the embodiment of FDA's apparent caution: Sidney Wolfe, M.D., of the consumer group Public Citizen, a frequent pharma critic, was a "temporary voting member" of the committee hearing the Fentora request.
Agency observers tell In Vivo that Wolfe will be at that table more often in the months to come--and the blog thinks that's a good thing, now that FDA has more post-marketing enforcement tools at its disposal, because Wolfe will push the agency "to use its new tools aggressively." Plus, his presence would be an added stamp of credibility: "If his opinions are built into the standard risk management reviews, then his concurrence should shield the agency (and drug sponsors) from further criticism." We'll be watching this one closely.
- see the item at In Vivo
ALSO: "New" CDER chief Janet Woodcock has been busy weighing in on risk-management plans, too--and trying to figure out how to implement other measures of the FDA Amendments Act, too. Report