Supreme Court Maintains FDA Approval Of Abortion Pill, Preserving Access For Now

The Supreme Court on Friday granted a request from the Justice Department to leave in place the Food and Drug Administration's approval of a widely used abortion pill, preserving access to the drug and reinstating a number of steps by the agency that made it easier to obtain while legal proceedings continue.

The decision from the court, which has a 6-3 conservative majority, came in the most significant case involving abortion since it overturned Roe v. Wade less than one year ago, a ruling that threw the legal landscape into chaos and led to near-total bans on abortion in more than 12 states. In addition to granting the Justice Department's request for emergency relief, the Supreme Court also approved a similar request from Danco Laboratories, the maker of the abortion drug mifepristone.

Justice Clarence Thomas said he would have denied the emergency applications, and Justice Samuel Alito dissented from the decision, writing that neither the Justice Department nor Danco have shown they are likely to suffer irreparable harm while the appeals process plays out. Alito authored the majority opinion reversing Roe.

The Biden administration and Danco turned to the Supreme Court in the legal battle over mifepristone after a federal judge in Texas suspended the FDA's 23-year-old approval of the drug on April 7, which would have disrupted access to the medication nationwide, including in states where abortion is legal. 

"The district court countermanded a scientific judgment FDA has maintained across five administrations; nullified the approval of a drug that has been safely used by millions of Americans over more than two decades; and upset reliance interests in a healthcare system that depends on the availability of mifepristone as an alternative to surgical abortion for women who choose to lawfully terminate their early pregnancies," the Justice Department wrote to the court.

The Biden administration asked the Supreme Court to pause the district court's order and aspects of a federal appeals court decision that limited how late into pregnancy mifepristone could be taken, who could prescribe it, and how it could be dispensed. The U.S. Court of Appeals for the 5th Circuit put on hold the most significant part of the district court's decision — halting the FDA's approval of mifepristone — but blocked the actions by the agency since 2016 that relaxed the rules surrounding the drug.

The appeals court also sped up the Biden administration's appeal of the district court decision, setting arguments for May 17.

"If allowed to take effect, the lower courts' orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA's ability to implement its statutory authority," Solicitor General Elizabeth Prelogar told the court of the decisions from U.S. District Judge Matthew Kacsmaryk and the 5th Circuit.

Hours after the Justice Department asked the Supreme Court to step in, Alito issued an administrative stay, which ensured mifepristone would remain available while the court considered the issue. Alito's order was set to expire at midnight Friday.

President Biden criticized the lower court's decision in a statement, saying it would have "undermined FDA's medical judgment and put women's health at risk." He reiterated that his administration would continue to fight against "politically-driven attacks on women's health," but urged the American people to elect lawmakers to Congress who support enshrining protections for abortion into federal law.

"I continue to stand by FDA's evidence-based approval of mifepristone, and my administration will continue to defend FDA's independent, expert authority to review, approve, and regulate a wide range of prescription drugs," the president said in a statement. "The stakes could not be higher for women across America."

The dispute over the abortion pill, brought by a conservative legal organization, thrust the Supreme Court back into the center of the national debate over reproductive rights. Further complicating the landscape for abortion access was uncertainty over mifepristone's availability after the court in Texas and a federal court judge in Washington issued conflicting orders one after another. The 5th Circuit's ruling days later, which imposed limits on the abortion drug, only added to the confusion.

Since the Supreme Court rolled back the constitutional right to abortion last June, more than a dozen states have banned or imposed stringent limits on abortion. In 15 states, restrictions are in place that make it harder for patients to obtain medication abortions, including by requiring the drugs to be provided by a physician.

Medication abortions have become increasingly common and accounted for more than half of all abortions in the U.S. in 2020, according to the Centers for Disease Control. Mifepristone is taken in combination with a second medicine, misoprostol, to terminate a pregnancy through 10 weeks gestation.

Since the FDA approved mifepristone in 2000, it has made several changes to the rules surrounding the abortion pill. In 2016, the agency increased the gestational age limit from 7 weeks to 10 weeks, reduced the number of required in-person clinic visits, and broadened the set of healthcare providers to prescribe the drug. In 2019, the FDA approved a generic version of mifepristone and in 2021 lifted a requirement that the pills be dispensed in-person, which allowed the drug to be prescribed by a provider during telemedicine appointments and sent by mail. Earlier this year, the Biden administration widened the availability of the abortion drug to more retail and online pharmacies.

The Justice Department has argued in court papers that the risk of serious adverse events from mifepristone is extremely low when it is taken as directed and warned the lower court orders "would scramble the regulatory regime governing a drug that FDA determined was safe and effective under the approved conditions." More than 5 million women have ended their pregnancies using mifepristone. 

But in a filing with the Supreme Court, the anti-abortion rights physicians and medical associations who sued the FDA over its approval of mifepristone said the 5th Circuit's order restores "a modicum of safety" for the pregnant women who use the drug and would not shut off access to mifepristone. Instead, the pill would be subject to the same restrictions in place for the 16 years following its 2000 approval.

"Both the Fifth Circuit and district court orders paint an alarming picture of this lawlessness — all to the detriment of the women and girls FDA is supposed to protect," they said.

The legal battle targeting medication abortion began in November with the lawsuit filed by the Alliance Defending Freedom on behalf of the doctors and medical groups. The challengers argued the FDA failed to adequately consider mifepristone's health and safety risks when it approved the drug in 2000. The case was filed in the federal court in Amarillo, where only Kacsmaryk, appointed by former President Donald Trump, oversees cases. 

Kacsmaryk's decision blocked not only the FDA's approval of mifepristone, but also the agency's subsequent actions expanding access to the drug. 

The 5th Circuit said, "it appears that the statute of limitations bars plaintiffs' challenges to the Food and Drug Administration's approval of mifepristone in 2000." But the appeals court said the agency "relied on zero studies that evaluated the safety-and-effectiveness consequences of the" 2016 changes.

Backing the Biden administration in its push to preserve mifepristone's FDA approval were 23 blue states and the District of Columbia and 235 Democratic lawmakers, who separately filed friend-of-the-court briefs with the Supreme Court warning the lower courts' orders would have far-reaching ramifications if allowed to stand.

"Decades after FDA's initial approval — yet somehow in an emergency posture — the district court intruded into FDA's drug approval process, casting a shadow of uncertainty over its decisions," a group of Democrats in the House and Senate told the court. "The perils of this unwarranted judicial intervention into science-based determinations can hardly be overstated."

On the other side of the aisle, 21 red states and 147 Republican lawmakers had urged the Supreme Court to leave the 5th Circuit's decision in place.

"By approving and then deregulating chemical abortion drugs, the FDA failed to follow Congress' statutorily prescribed drug approval process and subverted Congress' critical public policy interests in upholding patient welfare," the GOP members of the House and Senate wrote.