In March 2024, the US Supreme Court heard arguments in Food and Drug Administration (FDA) v Alliance for Hippocratic Medicine (AHM). The case, decided in FDA鈥檚 favor in June, involved a challenge to a series of FDA decisions that loosened restrictions on mifepristone the agency deemed unnecessary to the safety of patients pursuing medication abortion. One of the central issues in the case was whether the antiabortion physicians who sued FDA had legal 鈥渟tanding鈥� to do so. Standing refers to whether a plaintiff has or will imminently suffer a concrete injury to a legal interest caused by the defendant's actions that could be redressed by judicial intervention. Addressing the government鈥檚 assertion that AHM lacked standing because its members had not used or prescribed mifepristone, Justice Clarence Thomas asked the US solicitor general during oral argument: 鈥淸C]ould you give us an example of who would have standing to challenge鈥�these FDA actions?鈥�¹ Justice Samuel Alito pressed harder, asking, 鈥淪o your argument is that it doesn鈥檛 matter if FDA flagrantly violated the law,鈥�endangered the health of women, it鈥檚 just too bad, nobody can sue in court?鈥�The American people have no remedy for that?鈥�¹

The justices鈥� suggestion was that allowing the public to sue FDA over decisions they disagree with may be necessary to rein in an agency that would otherwise be legally unaccountable. Yet, in a prior case, Justice Alito stated, 鈥淸t]he assumption that if [plaintiffs] have no standing to sue, no one would have standing, is not a reason to find standing.鈥�² This was the reasoning that won out in AHM, as it should have. In a unanimous opinion, the Supreme Court held that "a plaintiff鈥檚 desire to make a drug less available for others does not establish standing to sue" and that these plaintiffs鈥� standing theories were insufficient due to both lack of injury and lack of causation.³

Setting aside this case鈥檚 outcome, it is important to recognize that court proceedings are not the only way to hold FDA accountable. As the government鈥檚 lawyer noted in AHM, even if these physicians could not sue, 鈥淸I]t would be wrong to suggest that if FDA had made a mistake and a drug were actually producing safety consequences that there would be nothing to be done.鈥�¹ In fact, a system of overlapping judicial, legislative, and executive remedies exert meaningful constraints on FDA, rendering the agency answerable to all branches of the federal government and to the public itself.

FDA is not immune from judicial oversight, although there are important limits. Private plaintiffs have often demonstrated standing to challenge FDA in court. For example, in Abigail Alliance v von Eschenbach, the Alliance was held to have standing to sue FDA for violating a purported constitutional right to access drugs that cleared phase 1 trials but were not yet approved (though the constitutional claim ultimately failed). Depending on the context, patients, clinicians, companies, states, and organizations may have standing to sue FDA. Generally, regulated entities are in the best position to challenge how they are regulated.⁴ Thus, a sponsor of a new drug application would have standing to challenge FDA鈥檚 denial of that application in court, although these cases are rare. An organization representing companies that market products newly subject to explicit FDA regulation, such as laboratory-developed tests, also would have standing to challenge FDA鈥檚 actions. In contrast, third parties, like patients, tend to be on shakier ground.⁴ Some laws create specific causes of action to allow nonregulated groups to establish standing, but there is no such provision for FDA decisions on marketing applications.⁴ Moreover, although patients may sue companies if injured by an approved drug, various limitations on lawsuits against the government generally prevent patients from suing FDA on those grounds. As a result, in some instances, there may be no one able to sue FDA to challenge a product鈥檚 approval, outside the constraints of the citizen petition process described below.

There are nonetheless other effective checks on FDA鈥檚 authority, both in general and regarding decisions about specific applications. Beyond the courts, the agency is highly accountable to Congress, which holds the 鈥減ower of the purse.鈥� In addition to annual appropriations establishing FDA鈥檚 budget, Congress has enacted 鈥渦ser fee鈥� legislation for most FDA-regulated product categories, requiring industry payments to fund various agency activities in exchange for FDA agreeing to certain performance goals. User fees do not, however, dictate the outcome of product reviews. Most user fee programs expire every 5 years, requiring reauthorization by Congress. In fiscal year 2022, user fees accounted for two-thirds of FDA鈥檚 human drugs program budget,⁵ rendering user fee bills 鈥渕ust pass鈥� legislation and creating a regular opportunity for Congress to shape agency activities and priorities.

In addition to financial control, Congress determines the scope of FDA鈥檚 jurisdiction, with authority to add, remove, or limit regulation of product classes. Congress also dictates the parameters FDA must apply when deciding whether to grant marketing approval to specific products, at times passing laws to tighten safety standards, as it did in response to concerns about Vioxx in the early 2000s, and at other times loosening efficacy standards, as it did when codifying the accelerated approval pathway. More broadly, the Congressional Review Act allows Congress to use 鈥渏oint resolutions of disapproval鈥� to consider legislation to prevent agency rules from taking effect or being reissued, although this approach is inapplicable to decisions on product applications, which are not rules. Congress also uses hearings to hold FDA accountable and sometimes to exert pressure, calling FDA officials to testify 17 times since 2022 on issues including vaccine safety, pandemic preparedness, infant formula shortages, and general oversight of medical product regulation.⁶

The long-running battle over mifepristone illustrates Congress鈥� reach. Over several decades, lawmakers sponsored dozens of bills and introduced several appropriations amendments intended to prevent mifepristone鈥檚 approval, although none was enacted.⁷ Congress also held multiple hearings on mifepristone, commissioned a report from the Government Accountability Office, and delayed confirmation of FDA commissioners,⁷ citing concerns about how they would approach the drug.

Beyond Congress, FDA is accountable within its own branch, the executive. The secretary of the Department of Health and Human Services (HHS), a presidential appointee, reviews all significant FDA regulatory proposals and may override FDA鈥檚 rulemaking and even decisions regarding particular drugs, as when President Obama鈥檚 HHS secretary overruled FDA鈥檚 decision to make the 鈥渕orning after pill鈥� available over the counter without age restriction.⁷ In addition, the White House Office of Management and Budget (OMB) reviews 鈥渟ignificant regulatory actions鈥� from executive agencies, with authority to clear new rules or encourage reconsideration or withdrawal; this excludes decisions on marketing applications, however. In April 2024, after a final FDA rule banning menthol cigarettes languished at OMB for months, President Biden鈥檚 HHS secretary announced the administration was not yet ready to proceed. The White House also holds FDA accountable by nominating the commissioner and retaining removal power. For example, President Trump鈥檚 White House reportedly threatened the commissioner鈥檚 job in an effort to speed authorization of Pfizer鈥檚 COVID-19 vaccine. Given these many opportunities for influence, several former commissioners have argued that, as a scientific agency, FDA needs greater insulation from the political process.⁸

Finally, FDA is accountable to the American people. The public can influence FDA through both presidential and congressional elections. In addition, FDA advisory committee meetings, called to discuss product applications and broader policies, include open sessions during which the public can comment. The public also may submit written comments on proposed regulations and draft guidances. More directly, individuals and organizations can request FDA action through citizen petitions. Such petitions may ask FDA to issue, change, or revoke a regulation; they can also seek relabeling of approved drugs to add newly recognized adverse effects or removal of products from the market. For example, several antiabortion groups petitioned FDA to revoke mifepristone鈥檚 approval and, later, to restore restrictions.⁹ However, the agency sometimes takes years to issue final decisions on citizen petitions, as it did for mifepristone.⁹ The agency鈥檚 failure to respond to a petition in a reasonable period of time can support a lawsuit compelling a response and FDA鈥檚 substantive response also can be challenged in court. Petitioners may prevail, however, only if FDA鈥檚 response is deemed 鈥渁rbitrary and capricious,鈥� a formidable standard.

FDA is not infallible, but it is also never unaccountable. Litigation is one mechanism to achieve that accountability, although it is not always ideal, especially given the resources it would take to defend FDA鈥檚 decisions against all who might disagree鈥攁nd the resources needed for litigants to challenge the agency. As the Supreme Court ultimately recognized in AHM, 鈥淸c]itizens and doctors who object to what the law allows others to do may always take their concerns to the Executive and Legislative Branches and seek greater regulatory or legislative restrictions.鈥�³ FDA answers in a plethora of ways across the federal government and directly to the public, leaving the American people with a wide array of remedies.

Corresponding Author: I. Glenn Cohen, JD, Harvard Law School, Griswold Hall Room 503, 1525 Massachusetts Ave, Cambridge, MA 02138 (igcohen@law.harvard.edu).

Published Online: June 18, 2024. doi:10.1001/jama.2024.11987

Conflict of Interest Disclosures: Ms Fernandez Lynch reported joining amicus briefs submitted on behalf of food and drug law scholars in support of FDA in the Alliance for Hippocratic Medicine cases; she receives funding from Arnold Ventures outside the scope of this work. Dr Lurie reported that the Center for Science in the Public Interest signed onto an amicus brief in the Alliance for Hippcratic Medicine cases and receives support from Harvey Motulsky and Arnold Ventures for work to promote scientific integrity and government transparency. Mr Cohen reported being a member of the ethics advisory board for Illumina and the Bayer Bioethics Council; he was compensated for speaking at events organized by Philips with the Washington Post, attending the Transformational Therapeutics Leadership Forum organized by Galen Atlantica, and retained as an expert in health privacy, reproductive technology, and gender-affirming care lawsuits; serving as an advisor to World Class Health; and joining amicus briefs submitted on behalf of food and drug law scholars in support of FDA in the Alliance for Hippocratic Medicine cases. Mr Cohen, as an appellate attorney for the US Department of Justice, represented FDA in the rehearing petition in Abigail Alliance v von Eschenbach, a case mentioned in this article.