A new Senate bill would hold the Food and Drug Administration accountable if it ignores its experts when it approves painkillers.
Sens. Joe Manchin, D-W.Va., Shelley Moore Capito, R-W.Va., and David Vitter, R-La., introduced legislation Wednesday that would revamp the agency’s drug approval process.
Under the bill, the agency must justify its approval if it ignores advisers’ objections when green-lighting a new painkiller. That approval can be overruled by the FDA commissioner, which would be a completely new power.
If the FDA continues to approve the painkiller and ignore adviser objections, the commissioner can be called before Congress to explain why.
The FDA calls for advisory committees of experts to review new brand-name drugs that treat all types of diseases. A committee reviews evidence about the drug, listens to the public and the company sponsoring the product, and makes a recommendation on whether it should be approved.
However, the recommendation is only that. The FDA usually sides with its advisers but it doesn’t have to.
In fact, ignoring its advisers is what prompted the bill.
In late 2013 the agency approved a controversial painkiller called Zohydro over the objections of its advisers, who were worried about its potential for abuse.
The drug, a long-acting version of other painkillers such as Vicodin, did not contain technology to help deter abusers. More drug makers are now including technology that prevents an abuser from crushing a pill so that it can be snorted and get high much easier or from chewing a pill to get the same effect.
The approval ignited a public firestorm. Lawmakers from both sides of the aisle were furious that the agency approved the long-acting painkiller even though prescription drug abuse is a chronic problem in the United States.
While the controversy over Zohydro has died down, Manchin has showed no signs of cooling off.
“The FDA has proven time and time again that it is willing to ignore its own experts and approve medications that harm consumers,” said Manchin, whose state of West Virginia has been hit hard by painkiller abuse.
