Regulatory Capture of the FDA and CDC

by Vins

When COVID-19 arrived, a frightened nation turned to two federal health agencies—the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) for guidance. Now, more than two years later, there are questions about the “regulatory capture” of these agencies—the term used for a form of corruption in which an independent regulatory agency ends up promoting the interests of an industry, profession, or group—and how regulatory capture may have impacted public health policies that have guided the national response to the pandemic. In a June 2021 article for the American Conservative, Maxim Jacobs asserted that the FDA has been captured “for quite a while.” Jacobs cites a 2016 BMJ report and a 2018 article published by Science as evidence for this claim.

The 2016 BMJ study assessed the “revolving door” between FDA regulators and the pharmaceutical companies the agency is charged with regulating. The study found that the “majority” of the FDA’s hematology-oncology reviewers who left the agency (15 of 26) “ended up working or consulting for the biopharmaceutical industry,” Jacobs reported.  The 2018 Science article  found that 11 of 16 FDA reviewers who worked on 28 drug approvals and subsequently left the agency subsequently took positions working at or consulting for the companies they had recently regulated.

In another case, Jacobs reported, the FDA overruled the concerns raised by its own scientific advisory committee when it approved a new Alzheimer’s drug marketed as Aduhelm, in 2021. An advisory committee of eleven members voted unanimously (with one abstention) not to approve the drug. The FDA ignored the committee’s vote and “approved it anyway,” Jacobs reported. The drug is now priced at $56,000 a year per patient. Perhaps this pro-pharma outcome is related to the fact that approximately half of the FDA’s budget for regulating the drug industry comes from fees the industry pays to expedite drug approval processes.

In a December 2021 article for Common Dreams, Brett Wilkins wrote that nine of the ten most recent FDA commissioners —representing nearly four decades of agency leadership—have gone on to work for pharmaceutical companies after leaving the FDA. Wilkins reported that Senator Bernie Sanders (I-VT) voted against President Biden’s nomination of Dr. Robert Califf to lead the FDA for a second time, citing Califf’s ongoing ties to major drug companies. “We need leadership at the FDA,” Sanders stated, “willing to stand up to the greed and power of the pharmaceutical industry.”

And what of the CDC?  In a February 2022 article for Tablet, Vinay Prasad wrote that, “when it comes to vaccination, the CDC has a single policy: All Americans should get three doses, regardless of age or medical conditions. This is not science as such, but science as political propaganda.” Prasad noted that the CDC is both a scientific agency and a political one, with a director appointed by the nation’s president. But, instead of balancing public welfare with executive branch priorities, “the CDC has been a poor steward of that balance, pushing a series of scientific results that are severely deficient,” Prasad wrote. The CDC, he continued has been “captured by the country’s national political system,” a “precarious” situation that “undermines trust in federal agencies and naturally leads to a trust vacuum.” that leaves the public to “a confused search for alternative sources of information.”

Sources:

Maxim Jacobs, “The Regulatory Capture of the FDA,” The American Conservative, June 12, 2021.

Brett Wilkins, “Citing Multimillion-Dollar Big Pharma Ties, Sanders to Vote ‘No’ on Biden’s Pick for FDA Chief”, Common Dreams, December 14, 2021.

Vinay Prasad, “How the CDC Abandoned Science,” Tablet, February 14, 2022.

Student Researcher: Cia Davis (San Francisco State University)

Faculty Evaluator: Kenn Burrows and Amber Yang (San Francisco State University)

Review Article with Credder

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