Here’s a quick thought experiment: What if the FDA operated more like the CIA?
That’s not a suggestion that the agency engage in eater surveillance or conduct covert drug-testing operations. Rather, it’s a question about the state of the agency’s political independence and how it can be protected in the face of partisan pressure.
If you don’t know: the Food and Drug Administration (FDA) is a subsidiary of the Department of Health and Human Services (DHHS), which is an agency nested under the executive branch of the federal government. Because of this arrangement, the head of DHHS, who is appointed by the president, has veto power over FDA rulemaking.
So why not make FDA an independent agency? Earlier this year, seven of America’s most recent FDA commissioners co-wrote a piece of commentary urging such a change in Health Affairs journal. Today, in a new article for Science magazine, a team of researchers considers the ways that doing so would benefit the FDA’s mission and protect consumers.
The FDA plays a crucial role in the lives of Americans. It’s responsible for making sure that the drugs available at our pharmacies, the ingredients in our makeup, and the additives in our food are safe for humans to use or consume. Twenty cents out of every dollar spent by American consumers goes toward food or medicine that’s regulated by the FDA. The per-person, per-year cost to fund the agency is a little over $9. It’s probably a better deal than Netflix.
More recently, in a dust-up over allegedly “forbidden words” that weren’t allowable at the Centers for Disease Control and Prevention (also under DHHS purview), there were questions about whether DHHS, CDC, and FDA were giving mixed messages. “FDA regulates a huge percentage of our economy and makes a huge difference to people’s lives,” says I. Glenn Cohen, professor at Harvard Law School and co-author of the paper. In addition, ongoing changes to FDA leadership make the current moment an apt time to consider the agency’s independence. In March, FDA commissioner Scott Gottlieb resigned from his role, after a brief tenure where he advanced a surprising number of Obama-era food policies. Currently, the agency is overseen by acting commissioner Ned Sharpless. The authors of today’s article suggest a few mechanisms by which FDA independence can be strengthened. For one, they recommend instituting six-year, cross-administration terms, which would shield the agency, to an extent, from the shifts in political alignment as a result of presidential elections. Additionally, they propose that Congress remove FDA from DHHS’s oversight. Lastly, they posited that the agency could become more financially independent outside DHHS, where its funding would no longer be contingent on DHHS approval. “Agencies that have budgetary independence and know that they can kind of survive and do the work […] has protected a certain amount of independence,” Cohen explained. The paper’s authors note that separating FDA from DHHS wouldn’t make the agency apolitical. The goal, rather, is to make political allegiances more explicit to those on the outside. “When science and politics collide, the optimal path is to delineate, as transparently as possible, the contribution of each,” they write. “The hope is, that when values clash, an independent FDA will navigate the conflict with the nation’s best interest in mind.”
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