A controversial amendment to the Food and Drug Administration Safety Innovation Act that would change the classification of common, hydrocodone-containing pain relief products from Schedule III to the more-restrictive Schedule II has pharmacy interest groups up in arms, but proponents say it would help address the epidemic of opioid addiction and overdose deaths.
Combination hydrocodone products such as Vicodin and Norco are currently classified as Schedule III drugs, meaning that prescriptions can be written with five refills and pharmacies are not required to lock them in a safe.
The amendment to the Prescription Drug User Fee Act (PDUFA) re-authorization bill would re-schedule hydrocodone from Schedule III to Schedule II, putting hydrocodone painkillers into the same category as OxyContin and Percocet. Hydrocodone is the most-prescribed prescription drug in the U.S., with 131.2 million prescriptions written in 2010 alone.
Pharmacy organizations are fighting the amendment, saying it will keep such medications out of the hands of patients who need them and increase health care costs.
The amendment’s author, U.S. Senator Joe Manchin (D-W.Va.), says the bipartisan measure would make it far more difficult to abuse addictive pain medicine.