What Is the FDA’s Role in Public Health?
Backgrounder

What Is the FDA’s Role in Public Health?

The U.S. health agency regulates the country’s foods and drugs, among other products. With the FDA’s role in drug development and nutrition policy and its COVID-19 pandemic response driving controversy, President Donald Trump is set to shake up its leadership.  
The FDA operates laboratories across the country to inspect food, medical, tobacco, and other products.
The FDA operates laboratories across the country to inspect food, medical, tobacco, and other products. FDA
Summary
  • The FDA is tasked with regulating an extensive range of food and medical products, significant portions of which now come from overseas.
  • The COVID-19 pandemic brought the agency’s responsibility for the authorization of vaccines, treatments, and diagnostic tests to the fore.
  • President Trump has elevated a noted FDA critic to lead the agency, signaling a potentially broader shift on drug development, vaccine policy, and nutrition guidelines.

Introduction

The Food and Drug Administration (FDA), the United States’ regulatory agency for food, medical, and an array of other products, is a critical part of U.S. public health infrastructure. Its role has expanded considerably with the proliferation of cross-border trade: today, significant portions of FDA-regulated products, including food and medical supplies, come from abroad.

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Criticisms of the agency center on the extent of its regulatory powers and the risk that FDA officials could be swayed by the powerful pharmaceutical lobby. The agency has in particular taken heat over its part in approving the drugs at the center of the national opioid epidemic. Its role in vaccine development and drug approvals also came into the spotlight in the COVID-19 pandemic. President Donald Trump’s choice of Martin Makary—a surgeon who has been critical of many aspects of the FDA—to lead the agency could signal sweeping changes in public health policy.

What is the FDA’s job?

More on:

Health

United States

Pharmaceuticals and Vaccines

Public Health Threats and Pandemics

COVID-19

The FDA is the U.S. federal regulatory agency for an extensive range of food- and health-related products, including drugs, medical devices, tobacco products, cosmetics, food for pets and livestock, and dietary supplements. Its primary role is to ensure that these products meet certain quality standards before they are introduced to the U.S. market. Altogether, FDA-regulated products make up about 20 percent of consumer purchases in the United States. The agency typically makes decisions on about fifty new drug and biological products every year.

How was it created?

The FDA’s origins can be traced back to the early twentieth century, with the U.S. Department of Agriculture’s Bureau of Chemistry, then led by chemist Harvey Wiley. Food and medicine were largely unregulated at the time, and manufacturers took advantage of the government’s hands-off approach by selling drugs with unsafe or addictive ingredients and using harmful additives to preserve food or mask expired goods. Wiley advocated for better consumer protections, while investigative journalists such as Upton Sinclair publicized hazardous practices in the food and drug industries. 

The passage of the 1906 Pure Food and Drug Act (also known as the Wiley Act), the country’s first major legislation on food and drug safety, banned the sale of adulterated or mislabeled products. In 1927, the Bureau of Chemistry was restructured to focus entirely on regulation, and was soon after renamed the FDA.

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How is it organized?

The FDA is led by the commissioner of food and drugs, a role appointed by the president with Senate approval and typically held by a medical doctor. 

The agency is headquartered in White Oak, Maryland, and has several hundred field offices and more than a dozen laboratories across the U.S. states and territories. The FDA, which has a staff of more than eighteen thousand people, has more than a dozen centers and offices: these include the Center for Biologics Evaluation and Research, the Center for Tobacco Products, and the Office of Women’s Health. Its budget in fiscal year 2024 totaled around $6.9 billion, with just over half provided by the federal government and the remainder from industry user fees. Since 1992, the agency has increasingly depended on collecting user fees from the manufacturers it regulates, raising concerns about its independence.

More on:

Health

United States

Pharmaceuticals and Vaccines

Public Health Threats and Pandemics

COVID-19

How does it fit in with other U.S. food and health agencies?

The FDA has been an operating division of the Department of Health and Human Services (HHS) since 1988. There are several other agencies within HHS doing work that intersects with that of the FDA. These include the Centers for Disease Control and Prevention (CDC), National Institutes of Health, and the Biomedical Advanced Research and Development Authority.

The FDA Is One of Many Health-Focused Agencies
Major HHS operating divisions, sized by FY2022 budget authority in the president’s budget request
An infographic showing major HHS agencies, including the FDA and eight others.

Administration for Community Living

$3.0B

Food and Drug Administration

Substance Abuse and Mental Health Services Administration

Centers for Disease Control and Prevention

$3.6B

$9.6B

Health Resources and Services Administration

$12B

Indian Health Service

$13B

$8.6B

Administration for Children and Families

National Institutes of Health

$83B

$51B

Centers for Medicare and Medicaid Services

$1.4T

Note: Budget authority is the congressionally authorized limit for spending that fiscal year.

During the COVID-19 pandemic, the agency worked alongside the CDC and others in the U.S. response, with the FDA’s core effort being the review and authorization of vaccine candidates and potential treatments for the disease.

Although the FDA is no longer part of the Department of Agriculture (USDA), its role is still tethered to that of the USDA, which houses the Food Safety and Inspection Service and the National Institute of Food and Agriculture. The USDA oversees animal health and meat, poultry, raw fruits and vegetables, and eggs, whereas the FDA protects public health by ensuring the safety of most other food, including milk, dairy products, and animal feed supply. The two agencies’ collaboration has increasingly entered into the spotlight as avian flu outbreaks in poultry and dairy cattle in 2024 have sparked nationwide concern. The FDA also closely coordinates with the Environmental Protection Agency on issues including food waste and pesticides in foods.

What does the FDA’s review process look like?

The FDA’s review process differs depending on the type of product. Drugs typically go through a twelve-step review process by the agency’s Center for Drug Evaluation and Research, with phases including animal testing, clinical trials, and facility inspections. Under the 1962 Kefauver-Harris Amendments, drawn up in response to severe side effects of the drug thalidomide, drugmakers (or sponsors) must prove that their products are not only safe, but effective. Though the agency provides input for clinical trials and reviews their findings, trials are conducted by the drug sponsors in a variety of settings, such as hospitals and universities. A 2018 Massachusetts Institute of Technology (MIT) study found that about 14 percent of all drugs in clinical trials eventually receive FDA approval.

The Path to FDA Approval
Major steps in the FDA’s drug review process
An infographic showing the path to FDA approval, including animal testing, clinical trials, and other steps.

Animal testing

Sponsor tests drug on multiple animal species to gather information about safety and efficacy

IND application

Sponsor submits an Investigational New Drug (IND) application, which includes initial findings and plans for human trials, for FDA review

Clinical trials

Sponsor undertakes three phases of clinical trials, progressively increasing the number of volunteers, to determine side effects, safety, and effectiveness of the drug

NDA application

Sponsor submits a New Drug Application (NDA), which includes clinical trial findings, for FDA review

Label review

FDA ensures appropriate information for both health-care professionals and consumers is included on the drug label

Approval

FDA either approves or rejects the drug for the U.S. market

Post-marketing monitoring

Sponsor submits periodic safety updates to the FDA

Food products, meanwhile, are the responsibility of the FDA’s Center for Food Safety and Applied Nutrition, which reviews many new ingredients and additives. FDA personnel also collect samples from food products and their environments, as well as conduct inspections of production facilities across the United States and abroad, with the authority to issue fines and recalls or even seek criminal charges. Notably, however, the agency does not have the authority to approve or reject food products before they go to market, nor does it approve most food labeling. (The USDA oversees use of terms such as “organic” and “non-GMO” or “non–genetically modified” on food labels.) FDA regulations do require that food packaging include nutritional information.

How has globalization changed the FDA’s role?

The FDA’s mandate has greatly expanded in recent decades, as the rise in global trade means it is now regulating products from hundreds of thousands of facilities across more than 150 countries. As of 2022, about 15 percent of the U.S. food supply is imported, including more than half of all fresh fruits, roughly one-third of vegetables, and more than 90 percent of seafood consumed. Similarly, the vast majority of biologic drugs and more than a third of medical devices used in the United States are imported. Today, nearly every branch of the agency is involved in some aspect of international cooperation, such as the review of imported products for entry into the country, or coordination and information sharing with global bodies including the World Health Organization (WHO).

Under frameworks set by the World Trade Organization and the United Nations’ Food and Agriculture Organization, the FDA coordinates with its counterparts in other countries to align standards [PDF] on food safety. As for drugs, it is a founding member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, a global, public-private, standard-setting body.

Foreign analogues such as the European Medicines Agency, Health Canada, and China’s National Medical Products Administration broadly share the FDA’s objectives of monitoring food and drug safety, and the FDA has information-sharing and other agreements with more than a dozen countries and the European Union (EU). However, there are notable differences across these regulatory bodies, and they do not always defer to FDA standards. For example, a decades-old EU ban on hormone-treated meat has been a sticking point in trade negotiations with the United States. Still, companies from around the world often first seek approval for their products by the FDA, and foreign regulators closely watch FDA decisions.

What was its role during the COVID-19 pandemic?

The FDA played a central role in the pandemic response, given its responsibility to authorize drugs, treatments, and vaccines to combat the disease. The agency issued emergency use authorizations (EUAs), which allow the use of an unapproved medical product during a health crisis if regulators determine its benefits are likely to outweigh its risks. The FDA has additionally offered vaccine developers guidance on conducting rigorous, randomized clinical trials prior to authorizing vaccines for broad use. However, it did not escape controversy, including over delays in authorizing COVID-19 tests in the earliest days of the pandemic and over concerns about pressure from the White House.

As part of the federal government’s Operation Warp Speed, which aimed to accelerate the vaccine-production process, the agency granted EUAs in late 2020 for a COVID-19 vaccine developed by pharmaceutical firm Pfizer and its German partner, BioNTech, and another by U.S.-based Moderna. The following February, Johnson & Johnson (J&J) received an EUA for its own vaccine. However, following rare cases of blood clotting, the FDA and CDC recommended pausing use of the J&J vaccine. Several weeks later, they lifted the pause, affirming their confidence in the J&J shot while attaching a warning of an increased risk of Guillain-Barré syndrome.

Additionally, the agency has authorized emergency use of certain therapeutics to treat COVID-19, including convalescent plasma (blood plasma of previously infected people who have created COVID-19 antibodies), certain monoclonal antibodies (laboratory-made proteins that mimic antibodies made by the body), and the antiviral drug remdesivir (which is now approved). At the same time, the agency has urged consumers against the use of unauthorized treatments for COVID-19, such as the antiparasitic drug ivermectin.

It is also up to the FDA to move from EUAs to full approval to vaccines and treatments if it determines that the scientific data exhibits the product’s safety and efficacy and that the product can be manufactured safely and reliably. In August 2021, Pfizer’s COVID-19 vaccine was the first to receive FDA approval. Pfizer’s application was granted priority review, which does not affect the length of clinical trials but how quickly the FDA assesses the application, which is one of several FDA strategies to speed up the availability of drugs.

What have been major criticisms of the agency?

The FDA has faced criticism in many areas, particularly over the extent of its regulatory powers, concerns about manipulation of health data and other misconduct, and the influence of industry on its reviews.

Some critics argue that the FDA wields too much regulatory power. At the start of the pandemic, critics in part blamed delays in the availability of COVID-19 tests on the agency’s strict regulations. Owners of small farms have similarly complained that FDA safety guidelines are costly and unnecessarily onerous, favoring large and factory farms that have the resources to comply.

Others say the agency should have more power and independence to prevent undue influence from politicians and powerful lobbies by the pharmaceutical, tobacco, and agricultural industries. In his last days as FDA commissioner in 2021, Stephen Hahn described being pressured by President Trump and top White House officials to move faster on COVID-19 vaccine reviews. That same year, the FDA experienced internal upheaval, including several high-level resignations, over pressure from the Biden administration to approve a vaccine booster schedule that some agency experts considered premature.

Many critics also point out that the FDA depends on the companies it regulates, including the biopharmaceutical industry, to fund its drug reviews: While the agency was once entirely taxpayer-funded, today almost half of its budget comes from the user fees paid by companies seeking drug approvals. Investigative reports by 60 Minutes and other news shows have detailed how FDA officials bowed to the makers of OxyContin as the company sought approval of the painkiller.

Additionally, the FDA has faced accusations that it can be unnecessarily cautious, costing lives and stifling innovation. Though the Kefauver-Harris laws are widely hailed as a major achievement, some argue that the burden of proving efficacy is costly and-time consuming. In the early days of the HIV/AIDS epidemic, activists called on the agency to speed up its research and approval process for drugs to fight the virus. In 2019, then Acting Commissioner Ned Sharpless acknowledged that the agency moved too slowly to regulate the use of e-cigarettes. Experts have put forth a variety of reform proposals to hasten the FDA’s approval process or, in some cases, bypass the agency.

However, critics argue that in other cases, the FDA’s review process is too fast, allowing products to move forward without sufficient rigor and putting Americans’ health at risk. An HHS watchdog is now investigating the fast-track approval process increasingly used by the FDA, including for an Alzheimer’s drug by the biotech firm Biogen after the drugmaker reportedly launched a behind-the-scenes effort to convince FDA officials to approve the drug. Others note that accelerated approvals could ultimately cost taxpayers due to insurance-coverage requirements for FDA-approved drugs.

Some detractors accuse the agency of overlooking research misconduct by drug developers, including failing to obtain informed consent from participants and submitting falsified or corrupted data, and lacking transparency in its clinical trials. Outcry has at times even come from within the agency: In 2009, unnamed FDA scientists and physicians spoke out about pressure from superiors to manipulate data in the review process. In a 2020 op-ed, former Principal Deputy Commissioner Joshua Sharfstein wrote that, to protect its integrity, the agency should reject outside pressure and increase its transparency with the public. Some scientists have called on the FDA to reconsider its reliance on industry fees; others, including former FDA commissioners, have proposed elevating it to an independent federal agency to increase its autonomy and streamline its powers.

What will an FDA under Trump look like?

Donald Trump’s second term is likely to fundamentally reshape numerous aspects of public health policy. Researchers found that FDA regulation safeguards plummeted under Trump’s first administration, which pulled the United States away from its role as a major global health player—principally by initiating Washington’s withdrawal from the WHO. In line with this, Trump has promised in his second term fundamental reform to “Make America Healthy Again” by deregulating health agencies, opposing “big pharma,” reducing processed foods, and rooting out harmful additives. In a slew of executive orders, Trump again pulled out of WHO on his first day in the Oval Office in January 2025. 

Trump’s FDA pick is Marty Makary, a Johns Hopkins University surgeon who has been among the FDA’s most vocal critics, especially on its pandemic response. During the pandemic, Makary called for the FDA to more quickly approve the mRNA vaccines and for the CDC to conduct more research on boosters. However, he was also highly critical of the vaccine mandates, arguing that they drove distrust in public health, and opposed face masks, especially for children, which he said were ineffective. 

Makary will be joined by a team of public health mavericks. Trump has selected Robert F. Kennedy Jr. (commonly known as RFK Jr.), an environmental lawyer, to run HHS, which oversees the FDA. His other health picks include Stanford University Professor of Health Policy Jay Bhattacharya to lead the National Institutes of Health (NIH); television personality Mehmet Oz to run the Centers for Medicare and Medicaid Services; and Janette Nesheiwat, a family and emergency medicine physician and television commentator, for surgeon general. The CDC candidate is Dave Weldon, a medical doctor and former Florida congressman critical of conflicts of interest at public health agencies.

On pandemic response, RFK Jr. and Bhattacharya both have strong views against lockdowns and vaccine mandates. On vaccines themselves, there are a range of opinions: RFK Jr. is a noted vaccine skeptic, Makary strongly backed the mRNA vaccine deployments but opposed mandates, and in Congress, Weldon fought to remove vaccine safety oversight from the CDC and transfer it to an independent entity under the HHS’s umbrella. 

Many of Trump’s health picks focus on nutrition and the food supply, with RFK Jr. pledging to crack down on common pesticides, herbicides, and food additives, while deregulating alternative products such as raw milk, stem cell therapies, and various other nontraditional medical treatments. (Makary says that excess processing has “poisoned our food supply.”)  

Some health sector experts have warned that the incoming administration’s pledges to hone in on chronic illnesses and heart disease are overlooking the prospect of another infectious disease outbreak, such as the rising fears over avian flu. “The new administration had better have a strong infectious disease response plan- and had better ensure public health and vaccine confidence stays high,” Jerome Adams, Trump’s first-term surgeon general, wrote on X. Waning vaccine trust will undermine the federal response to the potential next emergency, and if that’s the case, “they’ll be distracted with outbreaks for four years this time instead of one,” he said. 

Recommended Resources

The Congressional Research Service breaks down how the FDA approves and regulates drugs [PDF].

This CFR Backgrounder takes a deep dive into the role of the WHO

KFF’s Jennifer Kates and Josh Michaud write about how HHS, the FDA, and the CDC can influence U.S. vaccine policy.

For Think Global Health, Howard Sklamberg gets into why improving the FDA’s food safety program is vital.

For the New York Times, Michael T. Osterholm and Ezekiel J. Emanuel unpack how Trump’s administration could make it harder to get vaccinated.

 

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