Hamburg: FDA has power to require abuse deterrence in painkillers

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FDA Commissioner Margaret Hamburg

FDA Commissioner Margaret Hamburg says the agency has the legal authority to require that opioids come only in tamper-resistant formulations; she only needs some proof that they actually deter drug abuse and the agency will act, the Financial Times reports. In a letter to Rep. Fred Upton (R-MI), chairman of the House Committee on Energy and Commerce, Hamburg this week wrote, "If FDA determines that the new formulations significantly deter abuse, we have concluded that the FDA has legal authority ... to require generic versions of those products to have abuse-deterrent formulations as well." There is interest in Congress in requiring all opioids to have some formulation to make it harder for drug users to abuse them. Hamburg said the agency is reviewing whether it can and should seek to remove or refuse to approve those drugs not formulated to deter abuse. Her letter was sent just a day before the agency issued draft guidance on what it wants from studies by companies that pursue abuse-deterrent technology. The agency next month is holding two days of meetings to seek "scientific evidence" on the issue. Story (reg. req.) | More

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