Sharpless Outlines Priorities for Overseeing FDA’s “Huge Portfolio”

FDA’s new leader, Ned Sharpless, M.D., praised the talent and diversity of the agency’s staff in expressing amazement over FDA’s “huge portfolio” of programs and responsibilities and emphasized that he is not planning “any radical changes” from what FDA has been trying to accomplish. This means continued efforts to support the development of new treatments and cures and to increase competition to reign in prescription drug costs by approving more generic drugs and biosimilars. His actions will be “guided by science” and the need to protect and promote public health, he emphasized in an introductory speech to FDA staff this week.

Sharpless will seek further solutions to the opioid crisis and work to reduce cigarette use in adults and kids. And he pledged support for stronger communication around the safety and effectiveness of vaccines, citing his horror as a physician to see outbreaks of measles “making a tragic comeback because of vaccine avoidance.”

His work in cancer research and treatment, he noted, has made him a “champion” of the use of real-world evidence to speed clinical trials and to support regulatory decision-making around novel products. And he cited the importance of FDA’s field force in using enforcement actions to protect public health by halting drug counterfeiting, adulteration, untruthful advertising, and marketing dangerous products to children. A main initiative is to modernize and reform FDA oversight of the burgeoning dietary supplement industry, which recently has drawn agency warnings for marketing supplements with unlawful ingredients.

In the next week, FDA will launch a newly updated FDA.gov website, Sharpless announced, anticipating improvements in providing “more accessible, user-friendly” information important to consumers. Although he serves as FDA’s acting commissioner, he emphasized that he did not see his role as temporary or part-time, and that he planned to “proceed at full speed ahead.”