Opioids Compromise: What’s in it for FDA

Regulatory NewsRegulatory News | 26 September 2018 |  By 

The US House and Senate late Tuesday reached a consensus on a conglomeration of opioids legislation that will have far-reaching effects for the US Food and Drug Administration (FDA).

Among the provisions that will affect FDA include allowing the agency to require prescription opioids to be packaged in a three- or seven-day blister packs, further collaboration with the Customs and Border Protection (CBP) to stop illegal opioids at the border, new public meetings and guidance.

For instance, not later than one year after the date of the bill’s enactment, FDA will have to hold a public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat acute or chronic pain or addiction.

In addition, the bill calls on FDA to issue one or more final guidance documents to help address challenges to developing non-addictive medical products to treat pain or addiction.

“Such guidance will address the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence,” the text of the bill says.

That guidance will also include how FDA will assess evidence to support “the inclusion of opioid-sparing data in the labeling of non-addictive medical products intended to treat acute or chronic pain.”

And on the postmarket end, FDA also must issue guidance regarding the circumstances under which the agency may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug and how such a reduction could result in a change to its benefits and the risks to the patient.

FDA Commissioner Scott Gottlieb also will consult with various stakeholders and the CDC to develop evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain for the relevant therapeutic areas where such guidelines do not exist.

And to stop the spread of illicit opioid imports, the bill also strengthens FDA’s and CBP’s collaborations, and aims to provide for improvements to both agencies’ facilities, technologies and inspection capacity.

Other provisions include efforts to prevent “doctor-shopping” for opioids, increasing the number of behavioral and mental health providers and help for babies born in opioid withdrawal and help for their mothers.

The House and then the Senate still need to pass this consensus legislation before it can go to the president for his signature.

Bill Text


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