- The FDA is tasked with regulating an extensive range of food and medical products, significant portions of which now come from overseas.
- Amid the COVID-19 pandemic, the agency has been responsible for the authorization of vaccines, treatments, and diagnostic tests for the disease.
- Throughout its history, the agency has often faced criticism over its regulatory processes and decisions, including its approval of prescription opioids in the 1990s and, more recently, a controversial Alzheimer’s drug.
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.
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 work has also come into the spotlight amid the COVID-19 pandemic, as the FDA is tasked with reviewing all potential vaccines and treatments for the new coronavirus disease.
What is the FDA’s job?
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.
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.
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. Janet Woodcock is currently the acting commissioner, though several members of Congress oppose Woodcock’s candidacy for permanent chief because of her role in the approval of controversial drugs.
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. In 2020, it had a staff of more than eighteen thousand people. The FDA 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 2021 totaled around $6 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.
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.
Throughout the COVID-19 pandemic, the agency has 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 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.
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 tens of thousands of facilities across more than 150 countries. Between 10 and 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.
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 has been its role during the COVID-19 pandemic?
The FDA has played a central role, given its responsibility to authorize drugs, treatments, and vaccines to combat the disease. The agency has in many cases 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, which have involved thousands of individuals in the United States and abroad, prior to authorizing vaccines for broad use. However, it has not escaped 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 announcing that a warning about an increased risk of Guillain-Barré syndrome would be attached to the vaccine.
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 then up to the FDA to grant 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, a step that health experts say they hope will help convince vaccine-hesitant Americans to get vaccinated and make it easier for employers to mandate COVID-19 vaccinations. In this case, Pfizer’s application was granted priority review, which does not affect the length of clinical trials but how quickly the FDA assesses the application; it is one of several FDA strategies to speed up the availability of drugs.
Amid the country’s battle with the Delta and other variants of the virus that causes COVID-19, in August, the FDA authorized an additional COVID-19 vaccine dose for certain immunocompromised people, noting that it did not yet recommend a booster shot for others who are fully vaccinated. However, the Biden administration soon after announced that it will start offering booster shots to most adults by late September, a move that has reportedly caused discord within the agency and among public health experts. Meanwhile, the decision is looming over whether to grant an EUA for a vaccine for children under twelve years old or wait to grant approval.
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 chief, Stephen Hahn described being pressured by President Donald Trump and top White House officials to move faster on COVID-19 vaccine reviews. A 2018 ProPublica report documented how the FDA depends on the biopharmaceutical industry to fund its drug reviews. Investigative reports by 60 Minutes and others 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.
The Congressional Research Service breaks down how the FDA approves and regulates drugs [PDF].
The FDA offers virtual exhibits about its work and how the agency has changed over time.
The New York Times’ Farhad Manjoo argues that Americans desperately need a better FDA.
The Commonwealth Fund weighs the costs and benefits of relaxing some FDA regulations amid the COVID-19 pandemic.
Will Merrow created the graphics for this Backgrounder.