WASHINGTON — Senator Joe Manchin of West Virginia has introduced a bill that would force the Food and Drug Administration to withdraw the heavily criticized painkiller Zohydro, which has sparked a national debate about the abuse of pain medications.
Zohydro is the first single-ingredient hydrocodone drug ever cleared for U.S. patients. The extended-release pill contains up to five times more of the narcotic hydrocodone than older combination pills, such as Vicodin.
Manchin and other lawmakers have argued that the drug could be easily abused without a tamper-proof formulation. His bill would also prohibit the FDA from approving similar medications without such abuse-resistant features.
The announcement comes just hours after the FDA's commissioner testified in the Senate that Zohydro met the government's standards for safety and efficacy.