FDA challenged in lawsuit to withdraw mifepristone from US

Mifepristone (Mifeprex) and misoprostol, the two drugs used in a medical abortion, are seen June 17, 2022 at the Women’s Reproductive Clinic in Santa Teresa, New Mexico, which provides legal medical abortion services.

Robyn Beck | AFP | Getty Images

The Food and Drug Administration is at odds with anti-abortion doctors in an unprecedented legal challenge to their more than two-decade-old approval of a pill to terminate early pregnancies.

The Alliance for Hippocratic Medicine petitioned a federal district court in Dallas late last year to invalidate FDA approval and remove the abortion pill entirely from the US market.

The case has pushed the FDA into the midst of a bitter national battle over abortion access after the Supreme Court ruled last June that Roe v. pick up calf. If the lawsuit prevails, women in the US would lose access, at least temporarily, to the most commonly used method of abortion. The FDA’s powers to approve drugs would also be weakened.

The court could make a decision as early as February 10 if 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 v. Jackson Women’s Health Organization case, which ultimately led to the Supreme Court overturning state abortion rights.

Judge Matthew Kacsmaryk hears FDA challenge to abortion pill approval Kacsmaryk was appointed to the US District Court for the Northern District of Texas by former President Donald Trump in 2019.

If the alliance wins in a federal district court, the Biden administration would appeal to the 5th Circuit Court in New Orleans, a conservative court where 12 of its 16 serving judges are Republican-appointed. From there, the case could end up in the Supreme Court.

The FDA approved mifepristone in 2000 for use in combination with misoprostol as a safe and effective method of terminating early pregnancies. The drug regimen is currently approved for use up to 10 weeks gestation. Half of abortions in the US are performed with mifepristone and misoprostol.

“Extraordinary and unprecedented”

In their complaint, anti-abortion advocates argue that the FDA abused its powers by approving mifepristone under an accelerated process reserved for new drugs that would benefit patients with serious or life-threatening illnesses more than currently available.

They claim pregnancy is not a disease, mifepristone is no safer or more effective than surgical abortion, and claim the FDA’s actions have put patient health at risk.

The FDA described the lawsuit as “extraordinary and unprecedented” in its response filed earlier this month. Government lawyers said they could not find a previous example of a court challenging an FDA approval and pulling a widely used drug off the market.

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

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The public interest would be “dramatically damaged” if mifepristone were withdrawn from the market, government attorneys argued. It would endanger the health of more women and cause overcrowding and delays at clinics offering surgical abortions, they wrote in their response.

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

“If long-standing FDA drug approvals were so easily waived decades after they were granted, pharmaceutical companies could not confidently rely on FDA approval decisions to develop the pharmaceutical drug infrastructure Americans depend on to treat a variety of health conditions,” he said the attorneys for the Biden administration wrote.

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

“You can’t have individual states, let alone a single judge, who overturns all the scientific evidence that has been evaluated by the Federal Food and Drug Administration and usurps that power,” said Gostin, who led the Biden administration has advised policy on health issues in the past.

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

status and statute of limitations

The federal government has argued that the plaintiff medical associations and individual physicians have no legal standing because their claims for damages are speculative.

Two obstetricians, an emergency room doctor and a family doctor allege in the lawsuit that they treated patients who had complications from “chemical abortions.” The medical associations claim they have spent resources asking the FDA about its regulatory actions on mifepristone.

Aside from that, the federal government has also claimed that the statute of limitations prevents plaintiffs from challenging the FDA’s approval of mifepristone in 2000. According to federal law, Lawsuits against the US government must be filed within six years of an agency lawsuit.

However, the Alliance for Hippocratic Medicine has also asked the court to overturn a number of recent FDA actions against mifepristone. These include the agency’s approval of a generic version of the pill in 2019 and its decision in 2021 to allow the drug to be delivered by mail.

The Alliance argues that the delivery of abortion pills violates an 1873 federal law known as the Comstock Act, which declares anything designed or intended to induce an abortion unshippable.

But the Justice Department in a statement published at the end of Decembersaid the law does not prohibit the shipment of mifepristone and misoprostol if the sender does not intend to break the law.

“It gives the Post Office, the USPS, the legal basis where they feel they need to do what they do — which is keep shipping these drugs,” said Jennifer Piatt, an expert at the Center for Arizona State University Public Health Law and Policy said the DOJ statement.

It’s possible that the judge could block these FDA actions for 2019 and 2021, rather than withdrawing mifepristone from the US market entirely. The federal government has argued that even a more limited injunction “would place an undue burden on the public and health systems.”

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

FDA agency in post-Roe America

Regardless of the outcome in the Northern District of Texas, the abolition of state abortion rights has called into question how far FDA approval of new drugs will go in a post-Roe America.

The FDA earlier this month allowed retail pharmacies to begin dispensing mifepristone if they are certified by the federal government and the patient has a prescription from a certified healthcare provider.

CV and Walgreens, the country’s two largest drugstore chains, have said they will seek certification and offer the abortion pill in states where the law allows it. But a dozen states have banned abortion in almost all circumstances, and a number of others have restrictions on the sale and administration of mifepristone that run counter to FDA regulations.

The Attorney General of Alabama recently suggested that Women could be prosecuted for self-performed abortions with mifepristone. And Florida Pharmacies warned in a letter last week that dispensing the abortion pill directly to patients is illegal under state law.

However, the FDA’s powers derive from Congress’s constitutional authority to regulate interstate commerce. Legislators gave the agency the power to decide which drugs to bring into the United States based on whether they are safe and effective. This raises the question of whether the FDA’s approval of mifepristone pre-empts state laws banning it for abortions.

However, pharmacies are licensed by state agencies. In practice, this means states that have banned abortion have the power to revoke the licenses of pharmacies that dispense mifepristone in violation of local laws.

“For retail pharmacies that want to get into this space, they’re going to take a risk, and the risk they’re looking at is that they’re in a state with a total abortion ban,” Piatt said. “You will not want to start selling these items right away for fear of violating state law.”

Courts have in the past ruled that the FDA’s drug approval powers supersede state law. In 2014, Massachusetts sought to ban the pain reliever Zohydro, which contains hydrocodone, after declaring a public health emergency in response to the opioid crisis. But a judge in the federal district court blocked the effectiveness of the banarguing that Massachusetts obstructed the FDA’s mandate from Congress.

“If the Commonwealth were able to reverse the FDA’s findings and supersede its own requirements, it would undermine the FDA’s ability to provide medicines to promote and protect public health,” wrote US District Court Judge Ryan Zobel for Massachusetts.

How far the FDA’s authority extends in states with abortion bans that conflict with the agency’s decisions on mifepristone is a question that will be decided in federal courts in the coming months, Piatt said. FDA challenged in lawsuit to withdraw mifepristone from US

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