From Science to Politics: How Staffing Cuts, Deregulation, and the Rise of Political Influence Weakened the Structural Integrity of the FDA

by Devin Scarborough, Associate Member, University of Cincinnati Law Review Vol. 94

I. Introduction

The Food and Drug Administration (“FDA”), a scientific regulatory agency situated within the Department of Health and Human Services (“HHS”), has long served as the central guardian of public health by ensuring the safety of food, drugs, biologics, medical devices, cosmetics, radiation-producing electronics, veterinary products, and tobacco.¹ The FDA exercises broad statutory authority rooted in the Federal Food, Drug, and Cosmetic Act (“FDCA”) of 1938 and its subsequent amendments.² Historically, the agency has been recognized for its commitment to evidence-based decision-making. Yet, in recent years, that institutional foundation has been destabilized.³ The second Trump administration has implemented sweeping staff cuts and pursued an aggressive deregulatory agenda aimed at scaling back oversight of drug, biologic, and food-safety initiatives that directly undermine the FDA’s mission to protect consumers and public health.⁴ These efforts have coincided with increasing political pressure within the agency, intensified by the leadership approach of HHS Secretary Robert F. Kennedy Jr., heightening concerns about the erosion of scientific independence.⁵

This article examines the scope and implications of these shifts within the Agency. Part II evaluates the Trump administration’s recent executive actions and the growing political influence exerted over the FDA’s scientific and regulatory processes, arguing that these developments have materially weakened the agency’s capacity to conduct rigorous research and enforce essential public health protections for American consumers. Part III analyzes the tangible consequences of these changes, including documented increases in foodborne illnesses and the foreseeable risks of medical-product deregulation, while critiquing the Administration’s categorical rejection of evidence-based safeguards. Finally, Part IV contends that, absent deliberate corrective measures, the FDA’s institutional integrity and its ability to protect the public will continue to erode, leaving Americans increasingly vulnerable to preventable health and safety risks and diminishing trust in the efficacy of the FDA.

II. Background

A. Major Staffing Cuts

In an effort spearheaded by HHS Secretary Robert F. Kennedy Jr. to restructure and consolidate what he has characterized as a dysfunctional administrative apparatus, the Trump administration laid off approximately 10,000 employees across HHS, including 3,500 FDA workers, amounting to an estimated twenty percent reduction in the Agency’s workforce during the first months of 2025.⁶ These layoffs swept broadly across essential operational functions, eliminating staff in policy development, human resources, information technology, procurement, communications, and administrative support.⁷ In response, several senior officials resigned in protest, including Jim Jones, the FDA Deputy Commissioner for Human Foods. Others were dismissed or forced out, among them Dr. Peter Marks, head of the FDA’s vaccine division, and Brian King, director of the Center for Tobacco Products.⁸ Although HHS publicly asserted that FDA inspectors were not targeted, other reports indicate that toxicologists and microbiologists with critical roles in food-safety oversight were terminated, nearly the entire unit of Food Processing Science and Technology unit was dissolved, and, according to anonymous federal health officials, numerous employees within the Office of Inspections and Investigations were also removed.⁹

These staffing reductions have further exacerbated long-standing deficiencies in drug-manufacturing oversight. The Government Accountability Office (“GAO”) has repeatedly warned that FDA inspection capacity was inadequate even before the layoffs, and the 2025 cuts have further constrained the Agency’s ability to perform routine inspections of drug manufacturing facilities.¹⁰ The lack of proper staffing diminishes the frequency of inspections and the volume of product testing, increasing the likelihood that unsafe or substandard medical products will reach the market.¹¹ The downstream regulatory effects were immediate.¹² In the third quarter of 2025, the FDA’s drug approval rate dropped to 73%, a notable decline from the average approval rate of 87% observed over the previous six quarters.¹³ This slowdown has significant implications for the development and availability of biosimilars, lower-cost therapeutics that play a critical role in promoting market competition and reducing consumer drug expenditures.¹⁴ As approvals stall, consumers will be forced to pay elevated prices for brand-name medications.¹⁵

The workforce reductions have similarly impaired both domestic and international food safety operations. Virtually all personnel in the FDA’s Office of Policy and International Engagement were dismissed, undermining the Agency’s capacity to maintain routine communication with foreign regulators and to monitor outbreaks of food-borne illness abroad before contaminated products enter the United States.¹⁶ Foreign food-facility inspections have fallen to their lowest levels since 2011, excluding the COVID-19 pandemic.¹⁷ Domestically, state regulators perform approximately 90 percent of produce facility inspections.¹⁸ Yet in 2025, state budgets dedicated to managing active foodborne-illness outbreaks were reduced by 60%, and funding for routine produce inspections was cut by 40%.¹⁹ These changes leave the Agency structurally weakened and strained, while the public is increasingly exposed to the consequences of diminished FDA staffing and state budget restrictions.

B. Drug & Biologic Acceleration & Food Safety Deregulation

Under Secretary Kennedy’s leadership, the FDA has sought to (1) increase the rate of drug approvals; (2) abandon expert review of new drugs; and (3) take steps to consolidate food safety regulations. These actions reflect an effort to expedite and streamline FDA processes while de-prioritizing drug and food safety protocols to accomplish this goal.

1. The National Priority Voucher Pilot Program

The FDA has long relied on its Accelerated Approval Program to streamline the approval process of drugs and biologics intended to treat serious or life-threatening conditions for which no adequate therapies exist.²⁰ The Program permits the Agency to approve products based on surrogate endpoints, which are intermediate measures that may correlate with clinical outcomes, but do not themselves demonstrate a direct therapeutic benefit.²¹ This structure allows manufacturers to avoid the traditional and often lengthy clinical endpoint approval process. In recent months, however, the FDA Commissioner has significantly expanded on this practice through the creation of the Commissioner’s National Priority Voucher (“CNPV”) Pilot Program.²² Under this initiative, invited manufacturers may obtain review periods as short as one to two months for qualifying drugs and biologics.²³ To date, 15 companies have received CNPV vouchers by agreeing “to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need.”²⁴ Interestingly, a company may be awarded a drug voucher based on the drug’s pricing or manufacturing location, without considering the disease or condition it treats or currently available therapies.²⁵ Under the Program, certain drugs will be further expedited based on criteria not previously considered for accelerated approval.

2. Proposed Removal of Drug Advisory Committees

The FDA under the Trump Administration has also moved to eliminate the longstanding practice of convening FDA advisory committees composed of outside experts to review new drug applications.²⁶ These committees have historically played a central role in assisting the Agency with complex approval decisions. Committee members review scientific evidence, offer expert advice, and vote on whether the FDA should authorize a drug, vaccine, or medical device.²⁷ Despite this well-established function, George Tidmarsh, the head of the FDA’s Center for Drug Evaluation and Research, has asserted that these committees are simply unnecessary.²⁸ Robert Califf, a former FDA Commissioner, disagrees with Tidmarsh, maintaining that the advisory committees provide essential information that is accessible to the public and valuable to FDA scientists who must weigh diverse experts’ perspectives before approving complex drugs and medical products.²⁹ Holly Fernandez Lynch, an associate professor of bioethics and law at the University of Pennsylvania, likewise explains that outside experts frequently identify safety questions that FDA staff have not yet considered.³⁰ In response, Tidmarsh contends that the FDA’s recent decision to publish “complete response letters,” the Agency’s detailed explanations for declining to approve a product, offers transparency akin to that of an advisory meeting.³¹ Despite Tidmarsh’s assurances, the letters are unlikely to provide the transparency and insight offered during open discussions among field experts on complex drug approvals.

3. Food Safety Deregulation

In addition to the rollback of food-safety protocols resulting from FDA staffing cuts, the Centers for Disease Control and Prevention (“CDC”), which operates under HHS, has significantly scaled back the scope of the Foodborne Diseases Active Surveillance Network (“FoodNet”).³² FoodNet is a program that has long worked in partnership with the FDA to track infections transmitted through contaminated food.³³ FoodNet previously tracked and monitored Campylobacter, Cyclospora, Listeria, Salmonella, Shiga toxin-producing E. coli (STEC), Shigella, Vibrio, Yersinia, and Cryptosporidium (since 2017) infections.³⁴ As of July 1, 2025, FoodNet is now required to report only on Salmonella and STEC.³⁵ Monitoring for all other pathogens is now optional.³⁶ Although Salmonella and STEC remain leading causes of foodborne illness in the United States, other pathogens, such as Listeria, continue to pose substantial public health risks.³⁷ The effects of reduced surveillance were quickly felt. In October 2025, following the reductions in monitoring, a Listeria outbreak linked to prepackaged pasta meals resulted in six deaths and the hospitalization of at least twenty-five individuals.³⁸ This outbreak underscores the importance of FoodNet’s comprehensive monitoring system prior to intentionally weakening its food-safety protocols.

C. Politically Handcuffing The FDA

Although the FDA is a governmental agency, its work has traditionally been grounded in scientific evidence rather than political affiliation.³⁹ Under the leadership of HHS Secretary Robert F. Kennedy Jr., however, the lines between politics and science have become entangled as ideological priorities exert increasing pressure on FDA staffers and regulatory decision-making.⁴⁰ In 2025, the FDA approved a second generic version of the abortion pill mifepristone, a drug that has been safely and effectively administered to women since its initial approval in 2000.⁴¹ Shortly thereafter, Secretary Kennedy ordered an updated review of the drug despite the long history of safe usage, citing concerns about patient safety when the medication is taken “without proper medical supervision.”⁴² This unprecedented action followed the publication of a non-peer-reviewed report from the Ethics and Public Policy Center (“EPPC”), a conservative policy organization, titled The Abortion Pill Harms Women.⁴³

Kennedy’s directive has generated substantial backlash from the medical community and reproductive freedom allies. Stella Dantas, MD, president of the American College of Gynecology, has emphasized that “decades of reputable, peer-reviewed, scientific evidence and use data prove that medication abortion is safe and effective” and that the EPPC report “drives a myth that medication abortion isn’t safe.”⁴⁴ Medical studies have confirmed this, finding that over 99% of women who took medication abortion pills did not have serious complications.⁴⁵ In August, the American Civil Liberties Union (“ACLU”) filed suit seeking to compel the FDA to disclose records related to the renewed review of mifepristone, including any correspondence between the FDA and anti-abortion organizations, state and federal officials, and politicians aligned with greater restrictions on medicated abortion access.⁴⁶ The FDA has not yet responded to the lawsuit.⁴⁷ When political priorities are embedded within science-based governmental institutions, the integrity of evidence-based practices and regulations is compromised, increasing the risk of political bias and disregard for public health needs.

III. Discussion

Throughout the second term of the Trump administration, the FDA has experienced extensive structural and operational disruptions driven by substantial staffing cuts, drug-approval acceleration initiatives, food-safety deregulation, and overt political interference in an agency that is designed to function as a science-based regulator. These actions carry far-reaching consequences. The loss of both technical and scientific personnel threatens to undermine drug and biologics investigations, diminish effective food-safety enforcement, and impair the overall efficiency and credibility of the FDA.⁴⁸ In tandem, the administration’s efforts to accelerate drug approvals and scale back food quality controls further compound the strain created by these staffing reductions. Finally, the escalating politicization of the FDA heightens the risk of public distrust in the governmental agency charged with safeguarding the health of the American people.

The cuts to both foreign and domestic food inspections illustrate the immediate public health implications of these policy decisions. While foreign-produced food products have become an increasingly common source of foodborne illness outbreaks, American inspections of overseas facilities have fallen to historic lows in 2025.⁴⁹ This decline is particularly troubling given that most of the seafood and more than half of the fruit consumed in the United States originate from foreign countries. With diminished oversight, the FDA is failing to adequately monitor the safety of products entering the country and reaching American grocery shelves.⁵⁰ Domestically, parallel reductions in state budgets have left American facilities vulnerable to deadly outbreaks.⁵¹ Rather than remedying these inefficiencies, the HHS has intensified the risk by reducing the number of pathogens monitored through the FoodNet.⁵²

The blatant disregard for the American public’s food safety is astounding. It is no surprise that the United States has already seen a rise in foodborne illnesses throughout 2025, demonstrating how the erosion of surveillance and inspection capacities directly endangers public health.⁵³ In the interest of public health, HHS must reinstate comprehensive FoodNet monitoring and restore both FDA staffing and state funding necessary to maintain an effective food safety infrastructure. The American people deserve to feel safe when buying food for their families and should not be forced to bear the cost of a policy agenda that deprioritizes food safety.

The staffing cuts also threaten the integrity, efficiency, and reliability of the new drug approval process.⁵⁴ Reductions in scientific staff increase the likelihood that unsafe or ineffective drugs and biologics will enter the market, placing Americans at risk when they seek medical treatment.⁵⁵ With fewer FDA employees available to conduct inspections and review applications, new drug approvals will slow, thereby impeding the development of biosimilar drugs that provide lower-cost alternatives to brand-name medications. Ironically, the Trump administration has enacted an executive order aimed at lowering drug prices for American citizens, yet its actions at the FDA undermine that stated goal.⁵⁶ The Administration must reevaluate the implications of reduced staffing levels and lower inspection rates for drug quality and patient safety. These concerns are amplified by the implementation of the CNPV Pilot Program, which promises drug approvals in as little as one to two months.⁵⁷

Accelerating drug approval times at such a rapid pace without the FDA personnel needed to conduct sufficient product testing is reckless. If the FDA intends to pursue the CNPV Pilot Program, it must ensure adequate staffing to properly support operations. The proposed elimination of FDA advisory committees only exacerbates these risks. Without the independent expertise these committees provide, the FDA will have fewer opportunities to consult outside scientific experts on complex drug approval decisions and may become less accountable to the general public.⁵⁸

Finally, the growing political pressure within the FDA under Secretary Kennedy threatens the scientific integrity at the core of the Agency’s mission and risks further deterioration of public trust in federal public health agencies.⁵⁹ Kennedy’s lack of medical and scientific qualifications has drawn heightened scrutiny, particularly regarding his directive to re-review mifepristone, a medication proven safe and effective over decades of clinical use.⁶⁰ Scientists and medical professionals have expressed serious concern that the review may rely on “junk science” and unreliable or ideologically motivated sources rather than peer-reviewed scientific research.⁶¹ Because the FDA’s authority depends on its reputation as a credible scientific regulatory agency, the intrusion of political influence weakens the agency’s legitimacy in the public eye. As the former FDA commissioner, Robert Califf notes, “one reason that we have such great medical technology in the U.S. is that the FDA’s decisions about individual products have not been political.”⁶² It is imperative that the FDA remain rooted in its mission to promote and protect public health through rigorous scientific research that is free of partisan pressure and political bias.

IV. Conclusion

The FDA’s ability to safeguard public health depends on adequate staffing, rigorous drug testing and food safety protocols, and a regulatory framework that is grounded in scientific evidence rather than political ideology. Throughout the Trump administration’s second term, the Agency’s efficiency and efficacy have been significantly impaired by extensive staffing cuts, accelerated drug approval initiatives, and the erosion of established food safety controls. The Administration’s growing emphasis on political objectives rather than empirical evidence has further eroded the FDA’s credibility as a science-based institution.

Absent deliberate corrective action, the FDA will be further structurally weakened, and the risks to American consumers will continue to rise. Policymakers must restore prior staffing levels, reinstate comprehensive food safety protocols, reverse state budget cuts that undermine domestic inspection systems, ensure that drug developers have ample time to conduct rigorous scientific research, and preserve meaningful access to independent advisory committees. The FDA must also recommit to evidence-based decision-making free from political influence. Implementing these measures is essential not only to protect the public health of the American people but also to maintain public confidence and trust in the governmental agencies tasked with protecting them.

Cover Photo by Arno Senoner on Unsplash

Devin Scarborough

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