FDA chief grilled on approval of controversial painkiller

Food and Drug Administration (FDA) Commissioner Margaret Hamburg faced tough questions Thursday over the administration’s approval of the painkiller Zohydro, seen as highly addictive and easily abused.

Hamburg, in testimony before the Senate Committee on Health, Education, Labor and Pensions (HELP), defended the October decision to allow the drug on the market, even after an FDA advisory panel voted overwhelmingly against the move.

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“We recognize that this is a powerful drug,” Hamburg told the lawmakers. “We weigh carefully risks and benefits.”

Her remarks came amid concerns raised by the panel’s chairman on the spike of opioid-based painkiller prescriptions over the last decade — from roughly 144 million in 2002 to well over 200 million last year.

“I didn’t realize we were so painful in this country,” Sen. Tom Harkin (D-Iowa) said. “What is happening to our doctors in this country?”

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 combination drugs such as Vicodin, experts say.

Sen. Bob Casey (D-Pa.) added that Zohydro was approved without any abuse-deterrent properties, such as a formulation designed to make it difficult for the drug to be crushed into powder form or dissolved.

Hamburg noted that such designs do nothing to prevent the drugs from being abused or misused orally.

“I would love it if we had abuse-deterrent formulations that were actually effective,” she said. “Right now, unfortunately, the technology is poor.”

Hamburg stressed that Zohydro is approved as a Schedule 2 drug, meaning there are limits on prescriptions, refills are prohibited and there are increased security and reporting steps required in the drug’s administration.

Ultimately, she said, the FDA concluded that the drug would do more good than harm.

“Acute and chronic pain needs to be treated,” she said.

Thursday’s hearing came as lawmakers eye legislation that would revamp the FDA’s drug-approval process in response to the Zohydro decision.

Drafting the bill is Sen. Joe Manchin (D-W.Va.), who, along with 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 potentially could have improperly influenced the agency's decision to approve Zohydro.

Manchin, who is not a member of the HELP Committee, nonetheless appeared at the hearing to press Hamburg on the “pay to play” allegations. Afterward, he said Hamburg agreed to address the concerns.

“Americans are abusing, and many cases dying, at an alarming rate from highly addictive pain medicine, and it is shameful that the FDA would ignore its own experts to approve this drug,” Manchin said in a written statement after the hearing. 

This story updated at 2:14 p.m. to correct a mispelling of the drug Zohydro