Tag Archives: PDUFA

Manchin to Oxy Watchdog: “I will not give up this fight”

Earlier this week, pharmacy interest groups defeated an amendment to the Food and Drug Administration Safety Innovation Act that aimed to change the classification of hydrocodone-containing pain relief products 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. The provision had been accepted as an amendment to the U.S. Senate’s version of the bill, but it was cut from the final bill that reconciled the Senate and House provisions after the Generic Pharmaceutical Association objected to it, claiming it would restrict access and increase prices to the painkillers.

Today, Oxy Watchdog caught up with the amendment’s author, U.S. Senator Joe Manchin (D-W.Va.), who said the bipartisan measure was defeated due to the efforts of high-powered and well-funded lobbyists representing groups that have a huge financial stake in keeping these pills as accessible as possible. But he vowed to continue the fight against prescription drug abuse, and said he planned to re-introduce the amendment in the future.


Watchdog: Tell us more about the reasons you decided to introduce this measure. What’s the landscape like in West Virginia regarding prescription drug abuse?

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