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 dismissed 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.
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