- The U.S. Senate on Tuesday confirmed President Donald Trump's pick to lead the Food and Drug Administration, Dr. Scott Gottlieb, by a largely partisan vote of 57-42 in favor.
- Five Democrats and Angus King, an independent senator from Maine, joined Republicans in support of Gottlieb, a former FDA deputy commissioner who has pushed for the regulator to be more responsive and flexible in reviewing drugs, particularly complex generics.
- Amid concern Trump's deregulatory agenda could imperil patient safety, Gottlieb has vocally committed to upholding the FDA's "gold standard" for establishing the safety and effectiveness of new drugs.
Since being nominated by Trump in March, Gottlieb appears to have earned the support of much of the biopharma industry, which was initially concerned with several of the unconventional candidates floated as potential picks.
And despite "no" votes from most Senate Democrats, opposition to Gottlieb from was much more muted than some of the strident objections to other high level nominees, such as Betsy Devos for Department of Education or Tom Price for Health and Human Services.
Gottlieb had allayed some worries by committing to defend the FDA's mission in his confirmation hearings and vocally expressing support in agency staff. He is also likely to enjoy support from many corners for his desire to speed FDA review of generics, particularly complex ones.
But he'll also face scrutiny and questions about his plan of action to address the ongoing opioid crisis, which was a point of contention for a number of lawmakers.
During a confirmation hearing in April, Gottlieb indicated tackling the crisis will be a top priority for him, but Markey and Hassan are concerned he will weaken risk plans used by the FDA to control misuse.
A finer balance may be needed to stay above the ongoing fracas over drug prices in the U.S., an area which the FDA tries to keep at arms length.
President Trump infamously called out the drug industry for "getting away with murder" on drug prices and has intermittently appeared interested in potential legislation aimed at bringing costs down.
Trump has also pushed to streamline the FDA, and early on issued an executive order for all executive agencies to repeal two regulations for every new one they institute. For an FDA charged with implementing parts of the recently passed 21st Century Cures Act, such a deregulatory order could be challenging to manage.
Proposed cuts to federal spending on basic research at that National Institutes of Health could also broadly impact the biomedical industry under the Trump administration.
The drug industry breathed a sigh of relief when Trump decided against nominating two previously considered libertarian candidates who spoke the language of Silicon Valley more than that of Cambridge or the Bay Area. It remains to be seen, however, if Gottlieb will find an equilibrium between managing deregulatory demands and budget cutbacks from Washington and ensuring speedy and science-based oversight.