Now We Know Who'll Be in Charge

Leaving the more immediate drama on Capitol Hill aside, the Georgia Senate elections this week finally answered the most compelling question of the 2020 election cycle: who’s in charge? That turns out to be a Democratic President, a Democratic House, and a Democratic Senate so evenly divided that the Vice President may have to spend a lot of time in her Capitol offices.That resolution allows me to answer the question I am most frequently asked: is the outcome good for FDA? More specifically, will it be easier or harder to get increased appropriations for FDA in 2021 (for FY 22)?The change of Administrations is obviously important in answering the question. There will be a new Commissioner serving a different Secretary. In turn, they will be working for a President who has been a strong advocate for cancer research and who has emphasized a more aggressive approach to combating the COVID-19 pandemic. That combination should result in an environment in which many of FDA’s needs (e.g. more cell and gene therapy reviewers, stronger partnerships to assure food safety, increased attention to emerging infectious diseases) should be given strong consideration.However, it should not be forgotten that FDA received large increases in the first two years of the Trump Administration. Ultimately, it was the appropriators who provided the funding, but it was to support initiatives that had come from FDA and passed through OMB review on their way to becoming part of the President’s Request.The Senate situation is a bit different. Having spent 6 years working in the Senate -- including a change in the majority party -- I can attest to the profound differences between being a committee chair and a ranking member. Likewise, it matters a great deal as to who sets the floor agenda.That said, the new Democratic majority in the Senate will not, by itself, change FDA’s funding prospects in 2021. Generally, Senate Appropriations Committee staffers work together and this has certainly been the case on the Ag/FDA subcommittee.That is not to say that Senator Merkley (or whoever chairs the subcommittee) won’t have different areas of interest and emphasis. However, those will be developed within the context in which Senator Hoeven (or whoever is the ranking minority member of the subcommittee) will have his views reflected, as well.What matters in the Senate (as well as the House) is our ability to articulate the agency’s challenges and opportunities. We need to be able to show that with more resources, the FDA can produce significantly more value for the American people.Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.