Due to federal rules applicable to “acting” agency heads, the current FDA Acting Commissioner, Ned Sharpless, or another person, should be nominated to be FDA Commissioner by month’s end. In order to be named FDA Commissioner, Senate confirmation is required.

This is a critical time for FDA as they face the ongoing fiscal year-end Appropriation negotiations, legislative activity such as Drug Pricing legislation and their work in drug development, and product-regulated outbreaks and challenges to the general public health, such as drug purity, food product outbreaks and vaping tobacco products.

While there have been many candidates rumored to be in contention for the position, media reports are more frequently citing Administration sources that President Trump is going to name oncologist Dr. Stephen Hahn, of MD Anderson Cancer Center in Houston, to the full-time Commissioner position.  Sources on the Hill are not in disagreement, but add the process for vetting is still ongoing and changes could occur.  The deadline for action by November 1st, however, does not change.

While not the largest federal agency, the FDA is vitally important for consumer protection regulating commercial goods and services totaling $0.20 cents of every $1.00 in consumer goods sold in the U.S.   The Commissioner of Food and Drugs at FDA has tremendous power and responsibility to set regulatory priorities for the agency.