FDA denies making a promise on opioids

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Rep. Harold Rogers
Rep. Harold Rogers

Contrary to a claim by a Kentucky Republican congressman that he was assured by FDA that it would not approve new opioids unless they had abuse-deterrent formulations, the agency says it never made such a commitment. Rep. Harold Rogers made his claim in commenting to the New York Times on the agency's Oct. 25 approval of Zogenix's single-ingredient hydrocodone bitartrate analgesic Zohydro ER, the day after it said it had agreed to support regulatory restrictions on combination hydrocodone products.

The approval had “dismayed” public health advocates, the newspaper reported, noting that an advisory panel last December had voted 11-2 against it because it could lead to the same type of abuse and addiction as OxyContin before it was reformulated to deter abuse.

FDA Press Office spokesperson Morgan Liscinski said the agency's Office of Legislation “has reached out to Rep. Rogers' office regarding his comments.”

In an earlier statement on the controversy, FDA said it was “committed to ongoing efforts to reduce opioid misuse and abuse while seeking to ensure that patients in pain continue to have appropriate access to these products. We consider the development of opioid analgesics with abuse-deterrent properties to be a public health priority and are actively supporting product development in this area, but the science is still in its early stages and abuse-deterrent formulations are not available for most ER/LA analgesics. Accordingly, the FDA does not believe it is feasible at this time to require that all new solid oral dosage form opioids have abuse-deterrent properties.”

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