Abortion pill fight may have broader implications for FDA drug approval

Legal experts said that such a ruling, if upheld, could lead to a highly politicized regulatory environment, with approvals for controversial treatments facing court challenges and being thrust into the middle of culture wars. Coronavirus vaccines or hormone treatments for transgender people, they said, could be endangered by judges with no scientific background.

A ruling against the FDA "could be catastrophic for public health," said Aaron S. Kesselheim, a professor of medicine at Harvard Medical School who is affiliated with Brigham and Women's Hospital in Boston.

"An adverse ruling would be concerning for the FDA's authority and for the ability of people to receive consistent care for their conditions, in different states," Kesselheim said.

It remains unclear when a ruling will be delivered by U.S. District Judge Matthew Kacsmaryk, who was appointed by former President Donald Trump and is known for his conservative views on abortion and same-sex marriage. Lawyers are scheduled to present oral arguments Wednesday in Amarillo, Tex., a hearing that is being closely watched by political leaders, advocates on both sides of the abortion debate, regulators, pharmaceutical companies and public health advocates.

The suit was filed by Alliance Defending Freedom, a conservative legal group, on behalf of four antiabortion medical organizations and four doctors. Their challenge, if successful, would be another blow to abortion rights advocates after the majority-conservative Supreme Court last year struck down Roe v. Wade, ending the nation's constitutional right to abortion.

In the Texas case, the stakes are high and the issues complex, rooted in FDA regulations that rarely make for passionate public debates.

Mifepristone was approved in France in 1988 after two major clinical trials showed it was safe and effective for terminating early-stage pregnancies.

By 2000, the FDA approved the drug for medication abortion. It is used in conjunction with another drug, misoprostol, to essentially induce a miscarriage. Mifepristone was greenlighted under a set of FDA regulatory rules known as "Subpart H," created in 1992 as advocates pushed for ways to fast-track drugs to treat HIV/AIDS. Known generally as "accelerated approval," the process applies to drugs that are "intended to treat serious or life-threatening illnesses" and that provide a "meaningful therapeutic benefit" over existing treatments.

Over the years, the process has been used to approve drugs that treat Alzheimer's disease and cancer.

For mifepristone, the process wasn't exactly quick - it took more than four years for the abortion pill to get approval from the FDA, which implemented tough restrictions. Mifepristone could be dispensed only in hospitals, clinics and medical offices under the supervision of a doctor who had verified the dates of the pregnancy and could diagnose whether a patient had an ectopic pregnancy, which happens when a fertilized egg grows outside of the uterus.

By 2011, under authority from Congress, the agency imposed a safety protocol called REMS - for risk evaluation and mitigation strategies - to ensure that mifepristone's benefits outweighed the risks.

Over the years, the FDA has eased some of those restrictions and other conditions. The agency said in 2016 that mifepristone could be used during the first 10 weeks of pregnancy. More recently, it eliminated an in-person dispensing requirement, allowing retail pharmacies to be certified to give out the drug.

Medication abortion accounted for more than half of abortions in the United States even before the Supreme Court overturned Roe v. Wade in June.

In attacking the FDA's approval of mifepristone, the Alliance Defending Freedom's legal arguments are not necessarily new - in 2000, abortion foes publicly ripped the use of Subpart H. Citizen petitions were filed in 2002 and 2019. They were rejected, paving the way for the lawsuit filed last fall.

Among the claims from Alliance Defending Freedom:

· That pregnancy is not an illness and the "dangerous drugs" don't provide a more meaningful benefit over surgical abortion. The Department of Justice, which is defending the FDA's approval process in court, has said the process was appropriate, pointing out that its own rules say Subpart H is available for a serious or life-threatening "condition," regardless of whether they "were understood colloquially to be 'illnesses.'"

· That the FDA failed to study the safety of the drug and ignored harmful side effects. The government counters that clinical trials, which included more than 2,500 pregnant patients, "provided substantial evidence of effectiveness and showed a low rate of serious adverse events," including no deaths. Even before the U.S. clinical trial data was available, an FDA advisory committee voted unanimously that mifepristone's benefits outweigh its risks, the brief said.

· That the doctors who are suing have legal standing because, in part, they treated patients who claimed complications from the FDA's "unlawful approval" of the drug. The doctors also assert that because of an "increase" in women and girls suffering complications, other patients in emergency rooms suffered a "decrease in time, attention, and resources" from doctors - a claim the Justice Department called "layer upon layer" of speculation.

The suit also argues that because of the pill, doctors "lose the opportunity" to provide medical care throughout the pregnancy. The government scoffed at the claim, saying such an approach would allow a lawsuit over any FDA action - say, cardiologists suing over a new heart medication because patients would no longer need their services.

Critics say the legal theories in the lawsuit are specious, but they acknowledge that Kacsmaryk's ruling could sow confusion over FDA regulations, weakening an agency at a time when scientific and medical expertise are under attack, possibly inviting lawsuits over any number of previously approved medications.

"The FDA is virtually never reversed by a court on scientific decisions because courts invariably recognize that they don't have the expertise to make scientific decisions," said Scott Lassman, a D.C. attorney who specializes in FDA regulatory issues. "And it is even more rare - I'd say unheard of - for this type of scientific challenge to be made in court 20 years after FDA's decision."

Roger Severino, who led the civil rights office in the Department of Health and Human Services during the Trump administration, pushed back against the notion that a single court decision would have such broad implications for the FDA.

"FDA's mission is to guarantee the safety and efficacy of our drugs and prescriptions," said Severino, now a vice president at the Heritage Foundation, a conservative think tank. "They've clearly, rightfully, said that the abortion pill is effective, but effective at what? It's effective at ending a human life, and that goes contrary to its mission to guarantee the safety of drugs."

The judge could rule in a variety of ways, some of which could open the door to lawsuits from doctors and others challenging the FDA's approval of other drugs, according to the Kaiser Family Foundation, a nonprofit organization focusing on national health issues and the U.S. role in global health policy.

Kacsmaryk could determine that the agency did not apply a lawful review process for its initial approval of mifepristone, which "would be unprecedented for a Court to rule that the FDA did not properly approve a drug," Kaiser Family Foundation researchers wrote. Another option: a more limited ruling that would get rid of prior rules that eliminated the in-person dispensing requirement and allowed for telehealth abortions. Or he could toss the lawsuit, embracing the Justice Department argument that the groups don't have standing to sue.

The Biden administration has indicated it plans to appeal any ruling that restricts the medication. Such an appeal would go to the right-leaning U.S. Court of Appeals for the 5th Circuit before landing at the Supreme Court. Erik Baptist, senior counsel for Alliance Defending Freedom, earlier told The Washington Post that the group does not believe the case should go all the way to the nation's highest court because "the facts and the law very much support our side."

Drugmakers are also eyeing a decision closely.

The FDA has an onerous process for taking a drug off the market. Some legal experts also say an adverse ruling against the FDA could spook pharmaceutical companies that invest millions in researching and developing drugs with the assurance there's a high bar to remove a drug from the market once it has been approved.

"The FDA is the gold standard for determining whether a medicine is safe and effective for people to use," Priscilla VanderVeer, a vice president at Pharmaceutical Research and Manufacturers of America, the major drug lobby, said in a statement. "While PhRMA and our members are not a party to this litigation, our focus is on ensuring a policy environment that supports the agency's ability to regulate and provides access to FDA-approved medicines."