The FDA’s power to approve drugs faces sweeping challenge in lawsuit seeking to pull abortion pill from U.S. market

The Food and Drug Administration is squaring off with anti-abortion physicians in an unprecedented legal challenge to its more than two-decade-old approval of a pill used to terminate early pregnancies.

The Alliance for Hippocratic Medicine asked a federal district court in Dallas late last year to declare the FDA approval unlawful and completely remove the abortion pill from the U.S. market.

The case has thrust the FDA in the middle of the fierce national battle over abortion access in the wake of the Supreme Court’s decision to overturn Roe v. Wade last June. If the lawsuit prevails, women across the U.S. would lose access, at least temporarily, to the most commonly used abortion method. The FDA’s powers to approve drugs would also be weakened.

The court could issue a ruling as soon as Feb. 10 when it will be fully briefed.

The Alliance for Hippocratic Medicine is represented by the Alliance Defending Freedom, a Christian organization that played a central role in the Dobbs vs. Jackson Women’s Health Organization case that ultimately resulted in the Supreme Court abolishing federal abortion rights.

Judge Matthew Kacsmaryk is hearing the challenge to the FDA’s approval of the abortion pill. Kacsmaryk was appointed by former President Donald Trump to the U.S. District Court for the Northern District of Texas in 2019.

If the alliance wins in federal district court, the Biden administration would appeal to the 5th Circuit in New Orleans, a conservative court with 12 of its 16 active judges appointed by Republicans. From there, the case could end up at the Supreme Court.

The FDA approved mifepristone in 2000 for use in combination with misoprostol as a safe and effective way to end early pregnancies. The drug regimen is currently approved for use up to the 10th week of pregnancy. Half of abortions in the U.S. are performed with mifepristone and misoprostol.

In their complaint, the anti-abortion physicians argue the FDA abused its power by approving mifepristone through an accelerated process which is reserved for new drugs that would benefit patients with serious or life-threatening illnesses more than what’s currently available.

They contend pregnancy is not an illness, mifepristone is not more safe and effective than surgical abortion, and claim the FDA’s actions have put patients’ health at risk.

The FDA, in its response filed earlier this month, described the lawsuit as “extraordinary and unprecedented.” The government’s lawyers said they could not find any previous example of a court second-guessing an FDA approval and removing a widely available drug from the market.

The FDA determined that mifepristone is a safe and effective way to end an early pregnancy more than two decades ago based on extensive scientific evidence, the agency’s lawyers wrote. Decades of experience from thousands of women and their physicians has confirmed mifepristone is safer than surgical abortion or childbirth, they said.

The public interest would be “dramatically harmed” by pulling mifepristone from the market, the government lawyers argued. It would put more women’s health at risk and cause overcrowding and delays at clinics that provide surgical abortion, they wrote in their response.

A decision by the court to overturn the FDA’s approval could also harm future drug development, the government’s lawyers said.

“If longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions,” the Biden administration lawyers wrote.

Lawrence Gostin, an expert on public health law at Georgetown Law, said it would be “highly irresponsible” and “reckless” for a judge to overturn the FDA approval of mifepristone. It would have “disastrous” consequences and set a “cataclysmic” precedent, he said.

“You can’t have individual states let alone a single judge overturning all of the scientific evidence that’s assessed by the federal Food and Drug Administration and usurping that power for itself,” said Gostin, who has advised the Biden administration in the past on health policy.

“It would mean that any FDA regulatory or approval decision could be subject to the whims of a single federal court or state,” Gostin said.

The federal government has argued that the medical associations and individual physicians who filed the lawsuit do not have standing because their claims of harm are speculative.

Two obstetricians, an emergency department doctor and a family physician claim in the lawsuit that they’ve treated patients who have had complications from “chemical abortions.” The medical associations claim they spent resources petitioning the FDA over its regulatory actions on mifepristone.

Standing aside, the federal government has also contended that the statute of limitations bars the plaintiffs from challenging the FDA’s 2000 approval of mifepristone. Under federal law, lawsuits against the U.S. government must be filed within six years of an agency action.

The Alliance for Hippocratic Medicine, however, has also asked the court to overturn a number of more recent FDA actions on mifepristone. These include the agency’s 2019 approval of a generic version of the pill and its 2021 decision to allow delivery of the medication by mail.

The alliance argues that the delivery of abortion pills violates a federal statute from 1873 known as the Comstock Act, which declares anything designed or intended to produce an abortion as nonmailable.

But the Justice Department, in an opinion issued in late December, said the law does not prohibit the delivery of mifepristone and misoprostol when the sender does not intend to break the law.

“It’s giving the Post Office, the USPS, the legal ground that they feel they need to stand on to do what they’re doing — which is to continue to ship these medications,” Jennifer Piatt, an expert at Arizona State University’s Center for Public Health Law and Policy, said of the DOJ opinion.

It’s possible the judge could block these 2019 and 2021 actions by the FDA rather than completely withdraw mifepristone from the U.S. market. The federal government has argued that even an injunction which is more limited in scope “would unduly burden the public and healthcare systems.”

“Never say never,” Gostin said. “Some of these judges have proven to be real culture warriors. They do have the power to issue nationwide injunctions.”

Regardless of the outcome in the Northern District of Texas, abolishing federal abortion rights has called into question just how far the FDA’s approval of new drugs extends in a post-Roe America.

The FDA earlier this month allowed retail pharmacies to dispense mifepristone for the first time if they get certified with the federal government and the patient has a prescription from a certified health-care provider.

CVS and Walgreens, the nation’s two largest drugstore chains, have said they are applying for certification and will provide the abortion pill in states where the law allows. But a dozen states have banned abortion in nearly all circumstances, and a number of others have restrictions on dispensing and administering mifepristone that conflict with FDA regulations.

The attorney general of Alabama recently suggested that women could be prosecuted for self-managing abortions with mifepristone. And Florida warned pharmacies in a letter last week that dispensing the abortion pill directly to patients is illegal under state law.

But the FDA’s powers stem from Congress’ constitutional authority to regulate interstate commerce. Lawmakers gave the agency the power to decide which drugs are introduced into the U.S. based on whether they are safe and effective. This raises the question of whether or not the FDA’s approval of mifepristone preempts state laws that ban it for abortions.

Pharmacies, however, are licensed by state boards. As a practical matter, this means states that have banned abortion have the power to revoke the licenses of pharmacies that dispense mifepristone in contravention of local law.

“For retail pharmacies that want to get into this space, they’re going to be looking at risk and the risk that they’re looking at is that they’re in a state with a full abortion ban,” Piatt said. “They’re not going to want to start immediately selling those items for fear of violating the state law.”

The courts have in the past ruled that FDA’s drug approval powers supersede state law. In 2014, Massachusetts tried to ban the painkiller Zohydro, which contains hydrocodone, after declaring a public health emergency in response to the opioid crisis. But a federal district court judge blocked the ban from taking effect, arguing Massachusetts was obstructing the FDA’s mandate from Congress.

“If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health,” Judge Ryan Zobel of the U.S. District Court for Massachusetts wrote.

Just how far the FDA’s authority extends into states with abortion bans that conflict with the agency’s decisions on mifepristone is a question which will be decided in federal courts in the months ahead, Piatt said.