In First Address as FDA Commissioner, Gottlieb Highlights Opioids, Drug Pricing

The FDA’s new commissioner, Scott Gottlieb, addressed the agency’s full staff for the first time and highlighted the agency’s key role in combating the opioid crisis.

Gottlieb said the FDA would work to reduce the rate of abuse, as he outlined his vision for a more risk-based, patient-centric agency.

On drug pricing, Gottlieb said the agency could take meaningful steps to increase competition and bring low-cost alternatives to the market, especially with complex generic drugs and biosimilars.

He said the agency needs to “take steps to make sure the generic drug process isn’t being inappropriately gamed to delay competition and disadvantage consumers,” adding that he plans to expand on this topic in the coming weeks.