President Donald Trump has officially nominated Stephen Hahn to the position of FDA commissioner, a position held on an interim basis by Ned Sharpless since April. Hahn, who would be the first full-time commissioner since the departure of Scott Gottlieb in March, has held the position of CEO of the MD Anderson Cancer Center in Houston since May 2018, and had previously served as a senior investigator at the National Cancer Institute (NCI). Sharpless will formally return to the NCI immediately due to the Federal Vacancies Reform Act, which limits the amount of time a federal official can serve in an acting capacity to 210 days. The duties of the FDA commissioner revert to the secretary of Health and Human Services while the administration waits for the U.S. Senate to vet Hahn's candidacy for the FDA post. Alex Azar, secretary of the Department of Health and Human Services, said in a Nov. 1 statement that Admiral Brett Giroir, assistant secretary for health, will handle the FDA commissioner's responsibilities in the meantime.
The U.S. Senate passed a spending bill for the FDA and other federal agencies by a vote of 84-9 that would provide the FDA with $3.2 billion in discretionary funding, a slight increase over the slightly less than $3 billion for fiscal 2019. The bill passed by the Senate Oct. 31, H.R. 3055, assumes the agency would receive roughly $2 billion in user fees. The Center for Drug Evaluation and Research would receive $1.979 billion in taxpayer dollars, and the Center for Biologics would receive $432 million. The Center for Devices and Radiological Health would be funded with $505 million, with another $66.5 million for the National Center for Toxicological Research. H.R. 3055 assumes that device user fees will amount to $219.5 million and drug user fees will be $1.06 billion. Generic drug user fees are anticipated to reach $511.6 million, while fees for biosimilars are calculated at $39.6 million. The legislation, which must be reconciled with the House version, would provide the Patent and Trademark Office with $3.45 billion, an amount offset by user fees collected by the agency for activities such as processing of patent applications. H.R. 3055 also provides spending numbers for other agencies in the Department of Commerce, for the Department of Transportation, and the Department of the Interior. The current continuing budget resolution expires Nov. 21, although members of both the Senate and the House have indicated that Congress will be unable to pass bills for all federal spending until March 2020.