The Washington Post

High stakes in a Texas abortion pill lawsuit


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 welldocume­nted. 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.

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.

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