GOP lawmakers are praising the FDA’s 24-page draft guidance on abuse-deterrent, opioid painkillers. House Energy and Commerce Committee Chair Fred Upton (R-MI) and Sen. Tom Coburn (R-OK) issued a joint statement, commending the agency for meeting the draft-guidance deadline established by the Food and Drug Administration Safety and Innovation Act of 2012.
National Drug Control Policy Director Gil Kerlikowske "called the action a vital piece of the Obama administration's effort to curb" the nation's "prescription drug abuse epidemic." However, not everyone applauded the document's release. Former Republican Rep. Mary Bono Mack of California, who co-chaired the "Congressional Caucus on Prescription Drug Abuse before she was defeated in November," dismissed the FDA's nonbinding recommendations as "lip service," and called for "more definitive action."
Getting praised for hitting a Congressional deadline is faint praise. But the FDA’s efforts are a lot more than window dressing. Sorry, Mary.
The next issue to watch is how FDA deals with generic opiods – and whether Congress and the courts intervene.