WASHINGTON, D.C. — U.S. Senator Joe Manchin (D-WV) said he will pursue an investigation into the Food and Drug Administration’s approval of Zohydro, the first single-ingredient hydrocodone drug ever cleared for use by U.S. patients.
“What’s coming out in Zohydro is pure hydrocodone. It can be crushed. It can be snorted. It can be injected. Two pills are said to kill a human being,” said Manchin.
Zohydro is a painkiller and can contain at least five times more hydrocodone than previously available in combination pills like Vicodin. Currently, hydrocodone is the most frequently abused prescription drug in the United States, according to information from the Drug Enforcement Agency.
Manchin worked with the FDA to change the scheduling for hydrocodone in an attempt to limit access to it.
“We finally got them, this year, to agree to schedule from a Schedule III to a Schedule II and, by the time they were doing that, they come out and approve Zohydro,” said Manchin. “Then I go completely insane.”
The FDA approved the powerful and highly addictive Zohydro last year against advice from its own experts. Members of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 11-2 against allowing the painkiller to advance in the approval process.
“Pay-to-play” allegations have surrounded FDA conferences held prior to the drug’s approval. It’s alleged the manufacturer of Zohydro and other makers of painkillers paid for entry into a series of meetings with FDA officials through other academic channels.
Those with the FDA have denied the allegations, but Manchin is not convinced. He and Senator David Vitter (R-La.) are requesting financial records for two groups tied to the University of Rochester, one of the alleged organizers of the meetings.
Manchin said Zohydro, which could soon be available to patients, has the potential to add dramatically to the already epidemic levels of prescription drug abuse in West Virginia and across the country. He’s already introduced legislation to reverse the FDA’s approval of Zohydro unless it is reformulated to prevent abuse.
“This is life or death in West Virginia and it’s life or death around this country,” said Manchin on Wednesday’s MetroNews “Talkline.”