Saturday, December 7, 2019

Saturday, December 7, 2019

FDA reports progress in support of opioid recovery and treatment act

The U.S. Food and Drug Administration's (FDA) acting commissioner, Dr. Ned Sharpless, has released a statement on the agency’s efforts to address the opioid crisis as the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act marked its one year anniversary on Oct. 24.

On Section 3001 of the SUPPORT Act, which clarifies FDA regulation of non-addictive pain products, Sharpless reported that the agency held an advisory committee meeting to assess opioid analgesic-sparing outcomes in clinical trials of acute pain and issued the draft guidance, Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.

On Section 6012 about abuse-deterrent opioid formulations' access barriers under Medicare, in coordination with the Centers for Medicare and Medicaid Services, the FDA is working to submit a report to Congress on the adequacy of access to abuse-deterrent formulations (ADFs) of opioid analgesics under Medicare and the effectiveness of ADFs in reducing abuse and misuse, according to Sharpless' statement.

The agency has also taken steps to fulfill the requirements of Section 3002, evidence-based opioid analgesic prescribing guidelines and report; Section 3014, strengthening FDA and U.S. Customs and Border Protection coordination and capacity; Section 3022, restricting entrance of illicit drugs; Section 3032, safety-enhancing packaging and disposal, and Section 3041, clarifying FDA post-market authorities. 

“While we are proud of these accomplishments, we know that there is still more to do," Sharpless said in the statement. "We will continue to implement the SUPPORT Act to build upon our efforts and adapt our responses to confront the changing nature of the opioid crisis.”

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U.S. Food and Drug Administration (FDA)

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