Make FDA an Independent Agency: Politico Column

University of California San Francisco resident surgeon Nisarg Patel says FDA should be restructured as an independent agency to help protect it from the political pressures that have affected it for several decades and have been particularly obvious during the Covid-19 pandemic. Writing in a Politico opinion column, Patel points to the recent FDA reversal of an emergency use authorization for hydroxychloroquine and chloroquine and its withdrawal of approval for over 150 unreliable coronavirus antibody tests as examples of an agency beset by political pressure to take action and then having to reverse its action.

“To maintain the integrity of the scientific process and patient safety,” he writes, “it’s time to restructure FDA and make it an independent agency insulated from political interference. Historical precedent and the structure of other federal institutions, including the Environmental Protection Agency and Federal Trade Commission, offer Congress a legislative roadmap to do this.”

Patel says that for 50 years following its 1906 establishment FDA “largely operated as an independent agency defending consumer protections. Since the late 1960s, however, the agency has seen its authority progressively eroded in the face of heightened politicization…. Congressional lawmakers and the White House have turned typical FDA decision-making into a political football.”

Patel notes that in 1994 the Social Security Administration was made independent from HHS to skirt political pressure. “Today, amidst a national health crisis that relies on both patience and scientific rigor to fight back, FDA should be granted the same autonomy,” he says.

The article suggests some ways such a step could be taken, including sending FDA budget requests directly to Congress rather than to HHS and the Office of Information and Regulatory Affairs/Office of Management and Budget, and appointing FDA commissioners to a six-year cross-administration term as recommended by the Institute of Medicine.

“With the national economy, hospitals, and personal health of Americans under duress,” Patel concludes, “the pressure is on FDA to approve an effective Covid-19 treatment. The medical community is discovering new insights from the novel coronavirus at a breakneck pace, opening up a slew of possible therapeutics and interventions. But ultimately, products must be safe as well as effective. Although FDA is unlikely to ever be completely insulated from political pressure, making it an independent agency would help it navigate this and future pandemics, allowing it to keep its focus where it should be, on the protection and promotion of public health.”