Outgoing Food and Drug Administration Commissioner Scott Gottlieb may have been the most aggressive of all FDA leaders in addressing the problem of rising drug costs, albeit within the limited scope of his authority to address the issue. Now, he’s taking that initiative into the private sector.
Gottlieb will return to Washington-based conservative think tank the American Enterprise Institute, the organization said Friday, as a resident fellow on health policy studies. Gottlieb began working for the AEI in 2002 and, following other work in the private sector, was appointed as FDA chief in 2017.
The Washington Post reported Thursday that Gottlieb, who was expected to formally step down Friday, would focus at the AEI on drug prices and what he called the “market failures” that are keeping them high.
He announced his resignation last month, following rumors in January that he would resign, but that he nevertheless denied. According to the reports confirming his resignation, Gottlieb wanted to spend more time with his family. National Cancer Institute Director Norman Sharpless has been appointed as interim FDA commissioner.
In the Washington Post interview, Gottlieb said factors that keep prices high include an insufficient number of products on the market to constrain prices and branded drugmakers gaming the system to keep generics off the market; underdeveloped markets for orphan drugs that preserve monopolies; and various rules and strictures in areas like Medicare Part B.
As commissioner, Gottlieb strongly promoted competition as a way for the FDA to play a more active role in the drug pricing issue, although pricing itself is beyond the scope of the agency’s authority. This included publicizing complaints from generic drugmakers about branded drug companies that sought to make it harder for the former to obtain product samples to develop their own generic products. Other efforts included promoting development of biosimilars, particularly in areas like insulin products, given the skyrocketing prices of those.
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