Greer Donley, an Associate Professor of Law at the University of Pittsburgh School of Law, was a drafter and signatory of an amicus brief filed in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. Rachel Sachs is the Treiman Professor of Law at Washington University in St. Louis School of Law.
The lawsuit in Texas filed with the goal of removing a common abortion medication, mifepristone, from the market nationwide has the potential to disrupt the drug approval and development system more broadly. This could affect patients’ access to a variety of medications and weaken pharmaceutical companies’ incentives to develop new drugs.
The plaintiffs are asking for something unprecedented. They’re demanding that a generalist federal judge overrule the Food and Drug Administration’s expert scientific conclusions about the safety and efficacy of a drug that has been approved for more than two decades and remove it from the market.
If successful, this case could invite copycat lawsuits to limit other forms of politicized health care. Potentially at risk would be medications for a much larger range of indications, including contraception, HIV prevention and treatment, vaccines in general (as well as those specifically for covid-19), substance use disorder, gender-affirming care and others. The sudden loss of needed medications could be particularly harmful on short notice.
Already, bills at the state and local level seek to ban the administration of coronavirus vaccines. Employers offering health insurance have prevailed in an ongoing lawsuit in which they have requested not to provide coverage for HIV prevention medications on religious grounds. State legislators and conservative activists have begun to attack birth control. Seven states have already passed legislation limiting gender-affirming care for minors. This lawsuit in Texas provides a blueprint to expand these efforts by eliminating access to certain medications across the country, not just in limited jurisdictions.
If a judge can override the FDA and remove a drug from the market nationwide, particularly at such an early stage of litigation, it will undermine the interests of pharmaceutical companies as well as patients. Obtaining approval for a new drug is expensive, time-consuming and risky. It typically involves years or decades of research and can cost hundreds of millions, or even billions, of dollars. Most drugs that enter the research and development process fail, never making it to market. The prize at the end of this ordeal is the FDA’s approval to sell the product.
Recognizing this, Congress has established an administrative process involving many steps that the FDA must comply with before it can remove products from the market. This reassures the pharmaceutical industry that its approved products cannot be removed without serious, well-documented concerns about safety or efficacy. When the FDA does attempt to remove a fully approved product from the market, the manufacturer typically complies voluntarily.
It could chill innovation nationwide if political actors could circumvent the agency’s data-driven process by engaging the courts. Manufacturers might become wary of investing time and money into products for a wide range of conditions which may — decades down the line — be the subject of nuisance litigation. The pharmaceutical industry has grown increasingly risk averse in recent years.
Companies that have learned to navigate FDA requirements could no longer rely on one, predictable regulator but would be subject to conflicting judgments from around the country. Indeed, the industry has argued in favor of regulatory harmonization globally to ensure that the trials they conduct to demonstrate safety and efficacy are accepted by a broad range of national regulators, not just one. Lawsuits such as this reduce the predictability of the regulatory process within the United States.
These concerns could exacerbate existing health disparities. The products most likely to be at risk are disproportionately used by women, LGBTQ people, those with substance use disorders, and other marginalized groups. These populations are already underrepresented in drug discovery.
The potential impact of this case on reproductive rights has been well-documented. If Judge Matthew Kacsmaryk rules for the plaintiffs in Texas, his decision could threaten access to the gold standard of medication abortion throughout the United States. Providers, scholars and advocates are preparing alternative regimens — just in case — and pushing the FDA to consider how it can comply with an adverse order while permitting mifepristone to remain on the market. The government would be expected to appeal a ruling for the plaintiffs, a process that could be lengthy.
But the stakes in this lawsuit are broader than just one pill and one medical indication. Mifepristone’s safety and efficacy record is outstanding. The FDA followed sound procedures in approving it. If a judge can remove mifepristone from the market with such little notice, all drugs are vulnerable — those on the shelf, and those yet to be.