Reforming the FDA: Three Additional Changes

How might the Food and Drug Administration (FDA) be reformed?[1] In the February 2025 issue of Worst Pills, Best Pills News, I discussed eliminating the industry user fees that fund nearly half of the FDA’s approximately $7 billion annual budget and fully replacing them with taxpayer funding.[2] Among possible reforms, three additional changes are urgently needed.

Restricting the revolving door between working at the FDA and working in industry. FDA employees are frequently hired from companies that the FDA regulates or leave the agency to work in industry. Among recent examples, after holding oversight roles at the FDA about COVID-19 vaccines, two regulators went to work for Moderna, a leading vaccine manufacturer.[3] An October 2024 investigation found that over the last 15 years, “nearly two dozen FDA lawyers have left the agency and its Center for Tobacco Products to advise, litigate for or work with the tobacco and vaping industry.”[4] Although there are post-employment ethics restrictions for FDA officials,[5] they require strengthening.[6]

More rigorous marketing standards for medical devices. In general, the FDA’s approval and clearance process for medical devices is less rigorous than its drug approval process, as discussed in the January 2025 issue of Worst Pills, Best Pills News.[7] Most devices are considered low or moderate risk and are typically cleared for marketing through a “premarket notification” or 510(k) pathway, without any clinical data about their safety and effectiveness. A 2024 study in the Annals of Internal Medicine demonstrated the serious flaws of this approach.[8] The study examined cardiovascular devices subject to Class 1 recalls, the agency’s most severe designation. Of 137 Class 1 recalls involving 157 cardiovascular devices, about three-quarters (112) of the devices were moderate-risk 510(k) devices and only about one-quarter (45) were high-risk devices with clinical trials before they were approved. The FDA’s 510(k) pathway for device clearance has needed reform for years, with requirements for robust clinical testing of devices before and after they are marketed.

More information and increased transparency about the FDA’s regulatory processes. For a half-century, the FDA has had an outdated and overly restrictive approach to information sharing, as discussed in the December 2024 issue of Worst Pills, Best Pills News.[9] The FDA releases much less information than other global regulators, such as the European Medicines Agency, about drugs under review and approval decisions. The path forward for both clinicians and patients is more information about investigational treatments and drugs and other products in wide clinical use.[10]

The FDA must rely less on the voluntary release of information by companies and prioritize its own timely communications about the safety and effectiveness of medical products.
 

References

[1] Smith, DG. Kennedy wants to overhaul the F.D.A. Here’s how experts would change it. New York Times. December 22, 2024. https://www.nytimes.com/2024/12/22/well/fda-rfk-jr-scientists-reform.html. Accessed December 30, 2024.

[2] Steinbrook R. The FDA, user fees and Trump 2.0. Worst Pills, Best Pills News. February 2025.

[3] Doshi P. The FDA and Moderna’s cosy relationship: how lax rules enable a revolving door culture. BMJ 2023;383:p2486 (doi: 10.1136/bmj.p2486).

[4] Kranhold K. Former FDA lawyers join tobacco industry in ‘epic’ fight against the agency. STAT News. October 21, 2024. https://www.statnews.com/2024/10/21/fda-lawyers-work-tobacco-vaping-revolving-door/. Accessed December 30, 2024.

[5] Food and Drug Administration. Ethics restrictions after leaving federal service. February 18, 2020. https://www.fda.gov/about-fda/ethics/post-employment-restrictions. Accessed December 30, 2024.

[6] Smith, DG. Kennedy wants to overhaul the F.D.A. Here’s how experts would change it. New York Times. December 22, 2024. https://www.nytimes.com/2024/12/22/well/fda-rfk-jr-scientists-reform.html. Accessed December 28, 2024.

[7] FDA review of drugs and medical devices: what you need to know. Worst Pills, Best Pills News. January 2025. https://www.worstpills.org/newsletters/view/1639.

[8] See C, Mooghali M, Dhruva SS, Ross, et al. Class I recalls of cardiovascular devices between 2013 and 2022: a cross-sectional analysis. Ann Intern Med 2024; 177(11): 1499-1508. https://www.acpjournals.org/doi/10.7326/ANNALS-24-00724. Accessed December 28, 2024.

[9] Steinbrook R. The FDA and ‘confidential commercial information. Worst Pills, Best Pills News. December 2024. https://www.worstpills.org/newsletters/view/1632.

[10] Kesselheim AS, Sharfstein JM. Will the new administration’s FDA be a threat or an opportunity for the public’s health? Health Affairs Forefront. December 13, 2024. https://www.healthaffairs.org/content/forefront/new-administration-s-fda-threat-opportunity-public-s-health. Accessed December 30, 2024.