Manchin takes aim at FDA over approved painkiller

Sen. Joe ManchinJoseph (Joe) ManchinThe Hill's 12:30 Report Democrats desperate for a win hail spending bill Coal miners' union to endorse Manchin MORE (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 VitterDavid Bruce VitterTrump nominates wife of ex-Louisiana senator to be federal judge Where is due process in all the sexual harassment allegations? Not the Senate's job to second-guess Alabama voters MORE (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 SchumerCharles (Chuck) Ellis SchumerFox News host Watters says spending bill was 'huge defeat' for Trump Amtrak to rename Rochester station after Louise Slaughter Conscience protections for health-care providers should be standard MORE (D-N.Y.) each sent letters to Health and Human Services Secretary Kathleen SebeliusKathleen SebeliusPro-dependency advocates miss the mark in attacking Kansas welfare reform Pence breaks tie to confirm Trump's pick for religious ambassador The House needs to help patients from being victimized by antiquated technology MORE 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 McConnellAddison (Mitch) Mitchell McConnellYou just can't keep good health policy down Trump threatens to veto omnibus over lack of wall funding, DACA fix Democrats desperate for a win hail spending bill MORE (R-Ky.), Lamar AlexanderAndrew (Lamar) Lamar AlexanderOvernight Health Care: House passes .3T omnibus | Bill boosts funds for NIH, opioid treatment | Senators spar over ObamaCare fix | 'Right to Try' bill heads to the Senate Overnight Regulation: Omnibus includes deal on tip-pooling rule | Groups sue over rules for organic livestock | AT&T, DOJ make opening arguments in merger trial Warren presses Mulvaney, Azar on tip pooling MORE (R-Tenn.), ranking member on the Health Committee, and Tom CoburnThomas (Tom) Allen CoburnPaul Ryan should realize that federal earmarks are the currency of cronyism Republicans in Congress shouldn't try to bring back earmarks Republicans should know reviving earmarks is a political nightmare MORE (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.