In an unprecedented decision, a federal judge in Texas ruled April 7 to suspend the FDA's decadeslong approval of one of the two abortion pills, effective April 14.
The judge partly ruled in favor of four organizations and four physicians who filed suit in November against the agency for approving mifepristone, which is part of a two-drug regimen intended to terminate a pregnancy in the first 10 weeks. Medication abortion has been approved since 2000.
This is the first time a U.S. court has called for a drug approval to be revoked despite the FDA and the drugmaker opposing its removal. The preliminary injunction could, at least temporarily, hinder access to mifepristone across the country.
"The Court does not second-guess FDA's decision-making lightly," U.S. District Judge Matthew Kacsmaryk said in his decision. "But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.
"There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased 'access' to chemical abortion — which was the 'whole idea of mifepristone.'"
The case is ongoing. Danco Laboratories, a manufacturer of mifepristone, and the FDA appealed the ruling April 7.
"Today's regressive ruling on mifepristone jeopardizes the health of women across the country and undermines our entire system of drug approval," HHS Secretary Xavier Becerra tweeted April 7. "It opens the door for courts to overturn @US_FDA's evidence-based decisions for purely political or ideological reasons."
In a move to broaden access to mifepristone, 12 attorneys general filed a separate lawsuit in Washington on Feb. 23 against the FDA and HHS concerning mifepristone; but in this case, they argue the FDA added "burdensome restrictions" when it gave the drug Risk Evaluation and Mitigation Strategies restrictions.
The federal judge in this case ordered the FDA to keep mifepristone available in 17 states. This decision, also a preliminary injunction, was filed hours after Mr. Kacsmaryk's ruling. The contradictory rulings will likely head to the Supreme Court, according to The New York Times.
In January, the FDA said "public interest would be dramatically harmed" if mifepristone's approval was revoked. On April 8, the agency said mifepristone's "approval was based on the best available science and done in accordance with the laws that govern our work," added it "stands behind its decision" and thinks there should be continued access to FDA-approved medications.
After the Supreme Court overturned Roe v. Wade in June, anti-abortion organizations turned to block abortion pills. Medication abortion is the most popular way in the U.S. to end a pregnancy, and it has been used by 5 million people, according to Danco Laboratories.
The argument against the drug
Research has confirmed the drug safely works, but the Texas lawsuit does not exclusively target its safety and efficacy. Rather, it targeted the federal government's ability to approve it.
"The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an 'illness' and argue that these dangerous drugs provide a 'meaningful therapeutic benefit' over existing treatments," the plaintiffs said in a 113-page court document.
"But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion," the document said. "In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs."
The plaintiffs argued the FDA should not have approved an "unsafe drug regimen," nor should it have allowed patients to access mifepristone through telehealth during the pandemic.
Another argument against mifepristone is that it causes "cramping, heavy bleeding and severe pain." But, uterine bleeding is common in almost all patients during a medical abortion, and fatal infections and bleeding very rarely happens, according to the FDA's medication guide.
In the U.S., medication abortion is safe and 97.4 percent effective, the FDA says, and there are benefits to both surgical abortion and medication abortion, according to San Francisco-based UCSF Health and Los Angeles-based UCLA Health.
The argument against abortion pills also called on the Comstock Act, an 1873 rule that outlawed "immoral" and "indecent" publications to be mailed. The plaintiffs say this means abortion pills should not be cleared for mail orders. In December, however, the Justice Department said this law bans the mailing of abortion pills only if the sender knows they are for an illegal abortion, not if the patient lives in a state that legalizes abortion.
U.S. braced for this ruling
In January, the FDA cleared a path for some retail pharmacies to dispense mifepristone, and CVS, Walgreens and Rite Aid said they applied for the option. Before this allowance, the pill was primarily dispensed directly to patients in a clinic, medical office or hospital.
Danco Laboratories filed a motion against the Texas case, and a spokesperson said April 7 "is a dark day for public health, especially for reproductive rights and the reliance on science and medical expertise to guide decisions about what drugs are safe and effective and should be available to patients."
The pills' distributor, AmerisourceBergen, did not immediately respond to Becker's requests for comment.
In January, President Joe Biden directed HHS to offer more protections to abortion pill access, and Vice President Kamala Harris said the suit is an attack on healthcare's "fundamental rights."
"This is not just an attack on women's fundamental freedoms; it is an attack on the very foundation of our public health system," Ms. Harris said during a Feb. 24 press briefing. "Those who would attack this process and the ability of the FDA to make these decisions ought to look in their own medicine cabinets to figure out [whether] they're prepared to say that those medications that they need to alleviate suffering and to prolong the quality of life should no longer be available to them. Because that is what we are talking about."
She echoed these comments in more press calls on March 13 and March 16.
In a January post on its website, the FDA said it was "coordinating with the Department of Justice and others across the government" on what happens if a state refuses to allow mifepristone to be prescribed as an abortion pill.
What's next
Before now, there has never been a legal case against the FDA that asked the agency to retract a drug's approval. When the FDA looks to withdraw a drug from the market — which is not uncommon — the process takes weeks to months.
But a court requiring the FDA to do so is unprecedented, according to the Justice Department. Because not all manufacturers of mifepristone are part of the cases, it is unclear how the Texas and Washington rulings will affect them.
Mifepristone is approved to medically terminate a pregnancy in about 80 other countries, according to the FDA. Some providers in the U.S. told The Washington Post they will still perform surgical abortions or prescribe only the second abortion pill, misoprostol.
President Biden said his administration will fight this decision, adding, "If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks."
Misoprostol, the drug taken 24 hours after mifepristone in medication abortion, can be used on its own to terminate a pregnancy — but that option is less effective and slower, research shows.
"I'll fall out of my chair if the FDA is forced to rescind approval for this product based on this case," Caleb Alexander, MD, professor of medicine and epidemiology at Baltimore-based Johns Hopkins University, told the Fort Worth Star-Telegram in February. "It would mark a striking departure from the regulatory system that we have built over more than a century."