Gottlieb to FDA Staff: Immediate Challenge is Opioid Abuse

Regulatory NewsRegulatory News | 16 May 2017 |  By 

Scott Gottlieb, the US Food and Drug Administration’s (FDA) new commissioner, addressed agency staff for the first time late Monday, telling them that "unquestionably, our greatest immediate challenge is the problem of opioid abuse."

"This is a public health crisis of staggering human and economic proportion. The epidemic of opioid addiction is not a problem that FDA can solve alone. But we have an important role to play in reducing the rate of new abuse, and in giving health care providers the tools to reduce exposure to opioids to only clearly appropriate patients, so we can also help reduce the new cases of addiction.

Addressing this tragedy is going to be one of my highest initial priorities," he said, according to a transcript of the remarks.

He also said he will be working with FDA’s senior career leadership, and in the coming weeks hopes to have more to say on how we take even more forceful steps to address the opioid crisis.

In addition to opioids, he also touched on another pending crisis: the rising cost of pharmaceuticals. He noted that "too many consumers are priced out of the medicines they need. Now, I know FDA doesn’t play a direct role in drug pricing. But we still need to be taking meaningful steps to get more low-cost alternatives to the market, to increase competition, and to give consumers more options. This is especially true when it comes to complex drugs and biosimilars."

Moving ahead, he said the agency will be "forward-leaning when it comes to how we’ll evaluate safety and efficacy in view of emerging scientific insight and better analytical tools," noting the key priority of implementing the 21st Century Cures Act.

While acknowledging the agency’s staffing woes, he praised the agency’s effectiveness in accomplishing much with the "limited tools and resources we have available to us," and many of which "are being developed right here at FDA, in our labs, and at places like NCTR [National Center for Toxicological Research]."

And he also noted FDA’s re-alignment of its Office of Regulatory Affairs, saying it will "greatly improve FDA’s primary and principal public health protection role."


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