Manchin takes aim at FDA over approved painkiller

Sen. Joe Manchin (D-W.Va.) plans to introduce legislation in the coming days that would push back against the Food and Drug Administration (FDA) for approving a controversial prescription drug, his office confirmed Wednesday.

Manchin is working with several other senators on a bill that would target the FDA’s approval process, after the agency gave the green light in October to Zohydro, which critics say is a highly-addictive and easily-abused painkiller.

The bill could be released as early as Thursday.

“Manchin’s biggest concern is how Zohydro was approved and why it was even considered,” an aide to Manchin told The Hill.

Pressure is mounting for the FDA to withdraw its approval of Zohydro.

Last month, Manchin and Sen. David Vitter (R-La.) began investigating claims that members of the pharmaceutical industry paid tens of thousands of dollars to meet with representatives from the FDA, which critics say could have potentially improperly influenced the agency’s decision to approve Zohydro.

Manchin and Sen. Charles Schumer (D-N.Y.) each sent letters to Health and Human Services Secretary Kathleen Sebelius this month, calling on her to intervene and force the FDA to reverse its decision. She has jurisdiction over the agency.

In his letter, Manchin said the FDA “failed” in its duty to protect the public.

“Simply put, the FDA’s approval of Zohydro ER, in its current form, must be stopped before this dangerous drug is sold to the public,” he told Sebelius.

Three Republican senators — Minority Leader Mitch McConnell (R-Ky.), Lamar Alexander (R-Tenn.), ranking member on the Health Committee, and Tom Coburn (R-Okla.) — and a group of doctors previously also sent letters to FDA Commissioner Margaret Hamburg expressing their disappointment with the agency’s decision to approve Zohydro without any abuse-prevention measures.

Zohydro is the first FDA-approved drug that uses pure hydrocodone to treat chronic pain.
Other combination drugs mix hydrocodone with weaker, non-addictive painkillers such as aspirin to balance out the effects. But Zohydro contains up to 10 times as much hydrocodone as other combination drugs such as Vicodin, experts say.

The FDA approved Zohydro last October, contrary to the recommendation of one of its own advisory panels a year earlier, which warned against it because of the high levels of hydrocodone contained in the drug without any abuse-prevention measures.

Critics are concerned the FDA’s decision could increase prescription drug overdose rates and lead to abuse of the painkiller.