A Timeline of Policy Changes in the FDA

​By Amrita Acharya

Since the beginning of 2025, rapid change has come to the governmental departments overseeing public health. The Food and Drug Administration (FDA) is responsible for regulating the country’s food supply, drug production, medical devices, and many other such products that could impact public health (FDA, 2026). Although it’s nearly impossible to track the endless small changes that come with the upkeep of a federal institution, there have been some major changes that will have a huge impact on public health. ​

April 2025: Mass firings
What happened? Newly-appointed leaders throughout the government, including Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., vowed to reduce the workforces of their departments in a bid to remove unnecessary positions. This was quickly demonstrated in the FDA when around 3500 employees were laid off last April, with thousands more continuing to lose their jobs in the following months (Stein et al., 2025; “Thousands Laid Off,” 2025).

Why does it matter? Many crucial positions have been eliminated, causing slowdowns and bottlenecks throughout the organization. It takes longer to review new drugs and vaccines, meaning that less approvals can be done. Furthermore, the sudden firing has caused instability within the organization, as leadership resigns due to the changes, leading to a lack of clarity in policy (Libonate, 2025). Also, the FDA has historically had problems with understaffing, especially in foreign food safety inspections, so the firings will only lead to more problems with retaining foreign inspectors (GAO, 2026). 

August 2025: FoodNet surveillance reduced
What happened? FoodNet, or the Foodborne Diseases Active Surveillance Network, is a program that tracks eight foodborne illnesses as a collaboration with the FDA, CDC, USDA, and state health departments. At least, it used to be - as of August, all but two of these illnesses are no longer tracked (CDC, 2025). 

Why does it matter? FoodNet is the only federal program that actively tracks multiple foodborne illnesses - all other programs rely on state efforts. The reduced surveillance, therefore, has experts concerned that foodborne illness outbreaks could go undetected and the country will be ill-prepared to deal with them (Bendix, 2025).

November 2025: Insights into foreign food safety inspections
What happened? Due to staffing cuts, inspectors are less able to conduct planned or unplanned visits to foreign food production facilities. These kinds of inspections are critical to ensuring that the nation’s food supply is safe to consume and take months of planning and coordination (Waldman & Roberts, 2025). 

Why does it matter? In the past, foreign facilities have been found to be pest-ridden, unsanitary, and producing food unfit for consumption. Therefore, surprise inspections are necessary to ensure that conditions meet food safety standards. However, with the reduced workforce, many of these foreign inspectors now have to fulfill the roles of support staff instead of conducting investigations (Waldman & Roberts, 2025).

November 2025: Stricter vaccine approval requirements
What happened? The FDA has been considering tightening standards for vaccine approvals based on dubious claims that vaccines cause autism or that the COVID vaccine was linked to the death of ten children (Basilio, 2025; Lewis, 2025). Specifically, they propose to study new vaccines in all subgroups, increase required testing for the annual flu vaccine, and reconsider whether the flu and COVID vaccines can be given together. 

Why does it matter? The proposal specifically mentions testing vaccines on pregnant people, which ignores the risk to the fetus of including these people in test groups. Stricter requirements for the flu vaccine would make it more difficult for each new vaccine to be made annually for minimal additional benefit since the flu virus and the resulting vaccine rarely change drastically from year to year. Lastly, the flu and COVID vaccines are essential to preventing avoidable deaths or complications from illness. Taken together, these new requirements impose unnecessarily stringent requirements that could limit access to vaccines (Szabo, 2025).

February 2026: Looser drug approval standards
What happened? The FDA is planning to remove the requirement that any new drug needs two pivotal trials - a randomized trial to demonstrate that the new drug performs better than the existing drug on the market - and instead only requires one (Jacobus, 2026; Ledesma, 2024).

Why does it matter? The full impact of this change can only be seen with time. Some believe that it’s simply a formalization of de facto FDA policy, since many drugs were already being approved with one trial (Edwards, 2026; Jacobus, 2026). Others, however, worry that the one-trial requirement could exacerbate the lowering of rigorous standards for drug testing. While drug makers may have conducted many trials, only one of which shows a significant result, this rule may incentivize only reporting that one trial while disregarding all the evidence that the drug is not more effective (Kaplan et al., 2025; Tjandra, 2025).

The FDA is meant to be a cornerstone of public health, overseeing and regulating any and all related matters to ensure the country. However, in recent years, public trust in the FDA has eroded - 67% of Americans have confidence in career scientists compared to 43% in agency leaders at the CDC, FDA, and NIH (Adams, 2026; Soucheray, 2026).

It’s not difficult to see why this has happened. The new vaccine regulations, for example, allow false claims about vaccines to gain traction. The link between vaccines and autism has been debunked - the original study cherry-picked data and rigged results to show a connection when there was not one (Deer, 2011; MacDonald, 2011; Roos, 2011). However, these beliefs still persist in the public, as evidenced by anti-vaccination movements. 

This review of recent policy changes doesn’t include comments that high-profile FDA leaders have made, but these don’t help matters, either. RFK Jr., for one, has endorsed unsubstantiated conspiracy theories, including (but not limited to): the falsified link between vaccines and autism, false claims that unpasteurized milk is safe, denying that HIV causes AIDS, and misleading theories that fluoride treatment of drinking water is unsafe (BBC Verify team, 2024; Dorn, n.d.; Huynh & Rosenbluth, 2024). 

Scientific literacy these days is at an all-time low, leading to a distrust of scientific results. Many Americans don’t have the required scientific knowledge to parse these claims, instead choosing to blindly believe these leaders despite their claims not being rooted in science. The country is already seeing the effects of this, however, with recent measles outbreaks concentrated in anti-vaccine communities causing unvaccinated children to die (Halpert, 2025). 

Governmental agencies like the FDA have a certain level of responsibility towards the American public. And yet, instead of admitting to any wrongdoing or attempting to steer their policies back towards science, the agency has instead chosen to double down - the measles outbreaks were not met with encouraging parents to vaccinate their children, but rather policies that will make vaccine access more difficult. 

Overall, there’s been a clear shift towards deregulation, with the notable exception of vaccine approvals. Food and drug inspections have become easier to pass, promoting innovation, but innovation should not come at the cost of safety. In the places where more regulation is required, such as inspections and foodborne illnesses, the FDA is cutting back, and in places where scientific standards are already being met, the FDA is raising the bar. It is certain that these changes will bring negative effects to public health, but only time will tell the magnitude. 

References
1. Adams, S. (2026, March 5). Stark Divide: Americans More Confident in Career Scientists at U.S. Health Agencies Than Leaders. The Annenberg Public Policy Center of the University of Pennsylvania. https://www.annenbergpublicpolicycenter.org/stark-divide-americans-more-confident-in-career-scientists-at-u-s-health-agencies-than-leaders/ 
2. Basilio, H. (2025, November 20). CDC Vaccine Website Promotes Antiscience Claims of Autism Ties. Scientific American. https://www.scientificamerican.com/article/cdc-vaccine-website-promotes-anti-science-claims-of-autism-ties/ 
3. BBC Verify team. (2024, November 15). RFK Jr: Fact-checking his views on health policy. https://www.bbc.com/news/articles/c0mzk2y41zvo 
4. Bendix, A. (2025, August 26). The CDC quietly scaled back a surveillance program for foodborne illnesses. NBC News. https://www.nbcnews.com/health/health-news/cdc-quietly-scaled-back-surveillance-program-foodborne-illnesses-rcna227089 
5. CDC. (2025, December 17). About FoodNet. Foodborne Diseases Active Surveillance Network. https://www.cdc.gov/foodnet/about/index.html 
6. Deer, B. (2011). How the case against the MMR vaccine was fixed. BMJ, 342, c5347. https://doi.org/10.1136/bmj.c5347 
7. Dorn, S. (n.d.). Here Are All The Conspiracies RFK Jr. Promotes. Forbes. Retrieved April 23, 2026, from https://www.forbes.com/sites/saradorn/2024/11/15/rfk-jrs-conspiracy-theories-heres-what-trumps-pick-for-health-secretary-has-promoted/ 
8. Edwards, R. G. (2026, March 5). FDA Announces a Single Pivotal Trial as the New Default Standard for Drug Approval. ArentFox Schiff. https://www.afslaw.com/perspectives/alerts/fda-announces-single-pivotal-trial-the-new-default-standard-drug-approval 
9. FDA. (2026, April 20). U.S. Food and Drug Administration. FDA. FDA. https://www.fda.gov/ 
10. GAO. (2026, February 3). Overseeing Food and Drug Safety is Getting Harder at FDA | U.S. GAO. https://www.gao.gov/blog/overseeing-food-and-drug-safety-getting-harder-fda 
11. Halpert, M. (2025, April 12). Measles outbreak in west Texas worsens due to vaccine scepticism. https://www.bbc.com/news/articles/cwy7eyde3xeo 
12. Huynh, A., & Rosenbluth, T. (2024, November 22). 7 Noteworthy Falsehoods Robert F. Kennedy Jr. Has Promoted. The New York Times. https://www.nytimes.com/article/rfk-conspiracy-theories-fact-check.html 
13. Jacobus, N. (2026, February 19). FDA Removes Two Study Requirement for New Drug Approval Process: Report | PharmExec. https://www.pharmexec.com/view/fda-removes-two-study-requirement-new-drug-approval-process-report 
14. Kaplan, R. M., Koong, A. J., & Irvin, V. L. (2025, December 12). Opinion | Lowering FDA’s Drug-Approval Standards Is a Lose-Lose. https://www.medpagetoday.com/opinion/second-opinions/118993 
15. Ledesma, P. (2024, January 24). Pivotal Clinical Trials: Frequently Asked Questions. Sofpromed. https://www.sofpromed.com/pivotal-clinical-trials-frequently-asked-questions 
16. Lewis, T. (2025, December 1). Changing the FDA’s Vaccine Approval Process Could Threaten COVID, Flu Protection for Children. Scientific American. https://www.scientificamerican.com/article/changing-the-fdas-vaccine-approval-process-could-threaten-covid-flu/ 
17. Libonate, T. (2025, June 11). Measuring the Impact of FDA Personnel Cuts in 2025. Osprey Life Sciences. https://ospreylifesciences.com/measuring-the-impact-of-fda-personnel-cuts/ 
18. MacDonald, A. (2011, January 6). Good investigative reporting may finally debunk the myth that vaccines cause autism. Harvard Health. https://www.health.harvard.edu/blog/good-investigative-reporting-may-finally-debunk-the-myth-that-vaccines-cause-autism-201101061067 
19. Roos, R. (2011, January 6). Report says 1998 vaccine-autism study was fraud | CIDRAP. https://www.cidrap.umn.edu/public-health/report-says-1998-vaccine-autism-study-was-fraud 
20. Soucheray, S. (2026, March 5). Poll: Americans increasingly trust career scientists, not leaders, at CDC, NIH, and FDA | CIDRAP. https://www.cidrap.umn.edu/public-health/poll-americans-increasingly-trust-career-scientists-not-leaders-cdc-nih-and-fda 
21. Stein, R., Lupkin, S., Simmons-Duffin, S., Shapiro, J., Wroth, C., & Noguchi, Y. (2025, April 1). Widespread firings start at federal health agencies including many in leadership. NPR. https://www.npr.org/sections/shots-health-news/2025/04/01/g-s1-57485/hhs-fda-layoffs-doge-cdc-nih 
22. Szabo, L. (2025, December 1). FDA official proposes ‘impossible’ standards for vaccine testing that could curtail access to immunizations | CIDRAP. https://www.cidrap.umn.edu/childhood-vaccines/fda-official-proposes-impossible-standards-vaccine-testing-could-curtail-access 
23. Thousands Laid off From NIH, FDA and CDC After Supreme Court Decision. (2025, July 18). Pulmonology Advisor. https://www.pulmonologyadvisor.com/news/thousands-laid-off-from-nih-fda-and-cdc-after-supreme-court-decision/ 
24. Tjandra, K. (2025, December 17). Inside the FDA’s Quiet Move to Weaken Drug Approval Standards. MedShadow Foundation. https://medshadow.org/drug-updates-recalls/drug-safety/fda-reducing-clinical-trial-requirements/ 
25. Waldman, A., & Roberts, B. (2025, November 6). Foreign Food Safety Inspections Hit Historic Low After Trump Cuts. ProPublica. https://www.propublica.org/article/foreign-food-safety-inspections-historic-low-fda