FDA Chief Defends Approval of Controversial Painkiller

Dr. Margaret Hamburg appearing before a Senate committee on Thursday.
Dr. Margaret Hamburg appearing before a Senate committee on Thursday.

U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg defended the agency's controversial approval of the potent new painkiller Zohydro Thursday, saying people in pain need more options.

She rejected demands that the agency wait for a version of the drug that would be harder to abuse, saying there really isn’t a good abuse-proof formulation yet.

“I would love if we had abuse-deterrent formulation regulations that were actually effective,” Hamburg told a hearing of the Senate's Health, Education, Labor and Pensions Committee.

“It does not do any good to label something as abuse-deterrent if it is not actually abuse-deterrent.”

There’s a crush-resistant formulation of another opioid, Oxycontin, but Hamburg says that technology is not optimal. Nor are formulations of drugs that include acetaminophen, which can cause painful and deadly liver damage at high doses.

“We need to work with companies, scientists and the engineering community to come up with better abuse deterrents that actually work,” Hamburg said.

The FDA points out there's a large need for pain medications in the United States. The Institute of Medicine says about 100 million adult Americans suffer chronic pain every year, and the cost to the nation is between $560 billion and $635 billion annually.

Consumer advocates and law enforcement officials protested when the FDA approved Zohydro last October, noting that the agency’s own advisers had voted overwhelmingly against approval.

They demanded that the FDA reverse its decision. The drug went on the market at the beginning of this month.

"We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy," Hamburg told the hearing.

Hamburg said what the world really needs is better painkillers. “Acute and chronic pain needs to be treated. We don’t have a lot of good alternatives,” she said.

The federal government says nearly 5 million people in the United States abuse pain drugs, more than abuse sedatives, stimulants or other prescription drugs.