Ned Sharpless Holds the Gottlieb Line in Two Addresses to Health Organizations

Ned Sharpless, the acting commissioner of the U.S. Food and Drug Administration (FDA), intends to maintain the course set by the former commissioner, Scott Gottlieb.

That was the gist of a statement Sharpless gave several weeks ago to FDA staff and, so far, he seems to be sticking with the plan. During two presentations at different organizations in Washington, D.C. this week, Sharpless did not provide any hint of changing the direction at the regulatory agency set by his predecessor. According to RAPS, which reported on both addresses Sharpless gave, both speeches “revealed Sharpless’s evenhandedness and interest in keeping the agency headed in the same direction that former FDA Commissioner Scott Gottlieb steered it.”

Last month, Sharpless took over the reins of the FDA from Scott Gottlieb, who resigned from the post after two years on the job in order to spend more time with his young family. When Sharpless spoke to the FDA after taking over, he said the regulatory agency will continue on a mission to increase drug competition and “reign in prescription drug costs” through the generic drug and biosimilar programs that have been established at the agency. Additionally, Sharpless, who was tapped as acting commissioner in March, said the FDA under his guidance will continue to do what it can to help streamline the development of new treatments while “ensuring that we maintain FDA’s gold standard of safety and efficacy.” As acting commissioner, Sharpless, who is well known for his deep understanding of oncology and big data, said he has a commitment to science-based decision-making and will prioritize the FDA’s efforts to benefit the public health.

During an address to the Food and Drug Law Institute (FDLI), Sharpless pointed to some of the highlights the FDA made in 2018, the last full year Gottlieb was in charge, and particularly pointed to the agency’s continued response to the opioid crisis. Sharpless talked about new packaging rules for the powerful pain killers and greater regulation of amounts prescribed in hopes of keeping an excess amount off the streets. He also expressed concern over the measles outbreak that is hitting parts of New York City and Washington State. He raised concern over the resistance to vaccines that had eliminated the disease in the United States nearly 20 years ago.

At a separate meeting, Sharpless talked about how rapidly the FDA can approve new medications and how that has to be balanced against the rapid changes in the oncology market, RAPS said.

Even as Sharpless maintains the course, there are some questions as to how Sharpless will be able to navigate the halls of Congress in order to “maintain support and implement the broad spectrum of critical agency programs outlined in FDA’s 2020 budget request to Congress,” PharmTech said in a report on challenges facing the FDA in a post-Gottlieb world. With the strained relationships between the political powers in The House of Representatives and the White House, carefully protecting the FDA’s budget and innovations it can spearhead could prove to be a challenge for Sharpless as he continues on.