FDA Commissioner Testifies Before House Committee About the Agency’s Efforts to Combat the Opioid Crisis

On Oct. 25, 2017, FDA published remarks by Commissioner Scott Gottlieb, MD, that were prepared for his oral testimony before the House Committee on Energy and Commerce to give the committee an update on FDA initiatives created to fight the opioid crisis. Gottlieb also presented new guidance documents and steps to promote use of therapies to combat addiction.

Stating that opioid addiction is a devastating crisis of “massive proportion,” Gottlieb stated that opportunities to stop the spread of opioid addition were missed and “we find ourselves at a tragic crossroad.” He stressed that restrictions on prescribing or mandatory education for providers may be necessary, even if they make “certain parties uncomfortable.”

Updating risk management plans and FDA’s risk-benefit framework are needed to help prevent addiction, Gottleib stated, as well as extending education requirements. But he warned that prevention was not enough and stressed the importance of the use of medications to combat addiction.

The commissioner presented steps to the committee that included publication of a new guidance document to promote development of new addiction treatments. Gottlieb also stated that the use of current FDA-approved treatments for drug addiction is important to combat addiction. He stated that the agency would like to drive use of these medications by combating the stigma associated with them. The agency would also like to use current drug labeling data and perform research “to support a label indication for medication-assisted treatment for everyone who presents with an overdose, based on data showing a reduction in death at a broader population-level. Such an effort would be a first for FDA. We believe that granting such an indication in labeling can help promote more widespread use of, and coverage for, these treatments.”

“Committee members, we need to embrace long-term treatment with proven therapies to address this crisis. At FDA, we will step up our efforts to do our part to promote these goals,” Gottlieb stated.

Source: FDA