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Who's the Real Boss at the FDA?

Since 1992, the FDA answers both to Congress and to the companies they regulate.

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Dr. Robert M. Califf, Commissioner of the Food and Drug Administration, during a Senate Health, Education, Labor, and Pensions Committee hearing on September 14, 2022. (Stefani Reynolds / AFP via Getty Images)

When Patrizia Cavazzoni used to work at Pfizer, she reported to the pharmaceutical behemoth’s chief executive. Since she started working at the FDA, it's hard to see what's changed. As the director of the Center for Drug Evaluation and Research (CDER) at the regulatory agency, Cavazzoni knows that Pfizer and its peer institutions keep the lights on at the FDA.

The Prescription Drug User Fee Act (PDUFA), signed into law during the final months of the George H.W. Bush administration, permits departments within the FDA such as CDER to collect funds known as user fees from drug manufacturers seeking the approval legally required to market their products. For perspective, 65 percent of CDER’s $1 billion annual budget comes from user fees.

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According to a January 2020 article in the National Law Review, “PDUFA was an experiment; therefore, building in a sunset provision seemed wise.” The law expires every five years and requires congressional reauthorization; the last time user fees were reauthorized was through the Food and Drug Administration Reauthorization Act (FDARA) of 2017.

But the political environment surrounding the FDA is not the same as it was in 2017. That’s why pharma hawks have had their eyes on Congress for the past few months. User-fee agreements are set to expire at the end of September unless both chambers of Congress send a bill to the president reauthorizing the program. The commissioner of the FDA, Robert Califf, told his employees in a July memo that the agency has enough funding for five weeks after the next fiscal year starts on October 1.

There are separate pieces of legislation in the upper and lower chambers that would reauthorize user fees ahead of reconciliation. In the House, the Food and Drug Amendments of 2022 passed 392-28 in early June. All of the "no" votes came from Republicans, including Thomas Massie, Chip Roy, and Marjorie Taylor Greene. In the Senate, the Health, Education, Labor, and Pensions Committee passed the Food and Drug Administration Safety and Landmark Advancements Act (FDASLA) in mid-June by a vote of 13-9. The discrepancy between the House and Senate is worth noting: the House managed to pump out an almost unanimous bill, but the Senate just barely got their draft out of committee. And when the HELP Committee last took up FDARA in 2017, it passed 21-2, with only Vermont independent Sen. Bernie Sanders and Kentucky Republican Sen. Rand Paul voting no.

The Republican senators contacted by TAC were largely quiet when asked about this discrepancy between 2017 and today. One aide to a GOP member of the HELP Committee told us that “the version considered by the Senate HELP Committee earlier this summer included a battery of new burdensome federal regulations on the cosmetics and dietary supplements industries.” The staffer went on: “Worst of all, it would bring the oversight of diagnostic tests under the complete control of the FDA.” Politico reported on Tuesday that it’s “likely that major provisions to overhaul the regulation of dietary supplements, cosmetics and diagnostic tests will fall off the user fee package.” The GOP aide about did not respond when asked about this development.

Much of the sparring revolves around the negotiations taking place between Washington Democratic Sen. Patty Murray and North Carolina Republican Sen. Richard Burr, the HELP Committee chair and ranking member, respectively. The day after the HELP Committee passed FDASLA, Burr introduced the Food and Drug Administration Simple Reauthorization Act (FDASRA). The bill, as its name implies, simply reauthorizes user fees for the next five years but does not include the dietary-supplements, cosmetics, and diagnostic-test riders.

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But the user fees themselves are the problem for Michael Abrams, senior health researcher at Public Citizen’s Health Research Group. From his perspective, user fees are like “the fox paying the guard to the henhouse.” Abrams and other critics argue the relationship between the FDA and pharmaceutical companies is an example of regulatory capture, in which regulators work hand-in-glove with the commercial entities they're supposed to regulate.

Every five years, the FDA hosts separate discussions for industry representatives and stakeholder representatives. Executives from Johnson & Johnson, Mayo Clinic Labratories, and other pharmaceuticals companies are present at the former; advocates from Public Citizen, the Muscular Dystrophy Association, and others attend the latter. Abrams was Public Citizen’s representative for this cycle and attended stakeholder consultation meetings from September 2020 to March 2022.

After over a year of meetings, Abrams said that his “distinctive observation” was that stakeholder representatives were treated like “second-tier citizens when it comes to that negotiation process.” Abrams said that “the FDA says that they're going to listen to both of those entities giving input.... But what really happens is the industry and FDA talks—which are pretty closed, pretty secretive—end up being the ones that really drive the FDA’s commitment letter, and it's the commitment letter that forms the FDA’s ask of Congress.”

The researcher lamented that “it [was] evident when the commitment letter came out, there was nothing, no recommendations in there that I made multiple times in public fora, to enhance the drug oversight process. There were many things that industry wanted.”

Harvey Risch, professor emeritus of epidemiology at the Yale School of Public Health told TAC: “FDA needs a complete renovation, starting with its funding and upper-level decision-making personnel.” The professor continued, “The user fee program is bad law, a [completely] paradoxical incentives program that drives the FDA to depend upon and obey pharma money.”

Even after sustained negative media attention for the past few years, it’s likely that both chambers of Congress will agree to send the president a bill in the coming weeks that will extend user-fee authorization for the next five years. The spats between Sens. Murray and Burr will then be inconsequential, and pharmaceutical executives will get back to directing their subordinates at corporate, and at the FDA.

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