FDA battling lawsuit trying to withdraw mifepristone from US

Mifepristone (mifeprex) and misoprostol, two drugs used in medical abortion, are seen at a women’s reproductive clinic that provides legal medical abortion services in Santa Teresa, New Mexico, on June 17, 2022.

Robin Beck | AFP | Getty Images

The Food and Drug Administration has faced anti-abortion doctors in an unprecedented legal challenge over the more than two decades-old approval of a pill used to terminate early pregnancy.

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

The case put the FDA in the midst of a bitter national battle over access to abortion following the Supreme Court’s decision to overturn Roe v. Wade last June. If the lawsuit wins, women in the US will lose access, at least temporarily, to the most commonly used abortion method. The FDA’s drug approval powers will also be weakened.

The court may decide as early as February. 10 when he is fully informed.

The Hippocratic Medicine Alliance is represented by the Freedom Defense Alliance, a Christian organization that played a central role in the Dobbs v. Hippocrates case. The Jackson Women’s Health Organization case that eventually led to the Supreme Court’s overturning of federal abortion rights.

Judge Matthew Kachmari hears a complaint about FDA approval of an abortion pill. Kachmarik was appointed former President Donald Trump to the United States District Court for the Northern District of Texas in 2019.

If the alliance wins in federal district court, the Biden administration will appeal to New Orleans’ 5th district, a conservative court whose 12 of its 16 sitting judges are nominated by Republicans. From there, the case can go to the Supreme Court.

The FDA approved mifepristone in 2000 for use in combination with misoprostol as a safe and effective way to terminate an early pregnancy. The treatment regimen is currently approved for use up to the 10th week of pregnancy. Half of the abortions in the US, they are administered with mifepristone and misoprostol.

“Extraordinary and Unprecedented”

In their complaint, anti-abortion doctors allege that the Food and Drug Administration abused its power by approving mifepristone in a fast track designed for new drugs that could help patients with serious or life-threatening illnesses more than those currently available.

They argue that pregnancy is not a disease, that mifepristone is no safer or more effective than surgical abortion, and that the FDA’s actions have endangered the health of patients.

The FDA, in its response filed earlier this month, called the lawsuit “extraordinary and unprecedented.” Government lawyers said they were unable to find any previous example of a court questioning FDA approval and removing a widely available drug from the market.

The agency’s lawyers wrote that the FDA determined mifepristone was a safe and effective way to terminate an early pregnancy more than two decades ago based on extensive scientific evidence. According to them, the experience of thousands of women and their doctors over the years has confirmed that mifepristone is safer than surgical abortion or childbirth.

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Government lawyers argued that removing mifepristone from the market would “significantly damage” the public interest. This will endanger women’s health and cause overcrowding and delays at clinics that perform surgical abortions, they wrote in their response.

Government lawyers said the court’s decision to revoke the FDA’s approval could also be detrimental to future drug development.

“If long-standing FDA drug approvals could be so easily obtained, even decades after they were issued, pharmaceutical companies would not be able to confidently rely on FDA approval decisions to develop the pharmaceutical infrastructure that Americans depend on to treat a variety of diseases.” the study says. Biden administration lawyers wrote about this.

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

“It cannot be that individual states, let alone a single judge, overrule all scientific evidence assessed by the federal Food and Drug Administration and usurp that power for themselves,” said Gostin, who has consulted in the past. Biden administration on health issues. policy.

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

Reputation and statute of limitations

The federal government argued that the medical associations and individual physicians who filed the lawsuit lacked legal standing because their claims of harm were 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 petitioning the FDA over its regulatory action on mifepristone.

In addition, the federal government also argued that the statute of limitations prohibited plaintiffs from challenging the 2000 FDA approval of mifepristone. According to federal law, claims against the US government must be filed within six years of the agency’s action.

However, the Hippocratic Medicine Alliance has also petitioned the court to overturn a number of recent FDA actions regarding mifepristone. These include the agency’s approval in 2019 of a generic version of the pill and its decision in 2021 to allow mail-order delivery of the drug.

The Alliance contends that the delivery of abortion pills violates an 1873 federal law known as the Comstock Act, which makes it illegal for anything intended or designed to produce an abortion.

But the Justice Department in an opinion published at the end of Decembersaid the law does not prohibit the delivery of mifepristone and misoprostol when the sender does not intend to break the law.

“It gives the Post Office, USPS, the legal footing they need to stand on to do what they are doing, which is to continue to ship these drugs,” Jennifer Piatt, Arizona State University Center for Research expert. Law and policy in the field of public health, according to the opinion of the Ministry of Justice.

Perhaps a judge could block these FDA actions in 2019 and 2021 rather than withdraw mifepristone entirely from the US market. The federal government said that even a more limited injunction would “unreasonably burden the public and health care systems.”

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

FDA credibility in post-Roe America

Regardless of the results in the Northern District of Texas, the repeal of federal abortion rights has called into question how far FDA approval of new drugs extends in post-Row America.

The FDA earlier this month allowed retail pharmacies to dispense mifepristone for the first time if they were certified by the federal government and the patient had a prescription from a certified healthcare provider.

CVS and walgreens, the nation’s two largest pharmacy chains, said they are applying for certification and will supply abortion pills in states where it is legal. But a dozen states have banned abortion under almost all circumstances, and a number of others have restrictions on the issuance and administration of mifepristone that go against FDA rules.

The Attorney General of Alabama recently suggested that women can be held accountable for self-abortions with mifepristone. And Florida warned pharmacies in a letter last week that issuing abortion pills directly to patients is illegal under state law.

But the FDA’s authority stems from Congress’s constitutional authority to regulate interstate commerce. Legislators have given the agency the power to decide which drugs are imported into the US based on whether they are safe and effective. This raises the question of whether the FDA’s approval of mifepristone preempts state laws banning its use for abortion.

Pharmacies, however, are licensed by state boards. In practice, this means that states that have banned abortion have the right to revoke the licenses of pharmacies that dispense mifepristone in violation of local laws.

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

In the past, courts have ruled that the FDA’s drug approval authority takes precedence over state law. In 2014, Massachusetts attempted to ban the hydrocodone-containing pain reliever Zohydro after declaring a public health emergency in response to the opioid crisis. But a federal district court judge blocked the banarguing that Massachusetts obstructed the FDA’s mandate from Congress.

“If the Commonwealth were able to reverse the FDA’s decisions and replace them with its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect public health,” wrote Judge Ryan Zobel of the U.S. District Court in Massachusetts.

How far the FDA’s power extends to states with abortion bans that conflict with the agency’s decisions on mifepristone is a matter that will be decided in federal courts in the coming months, Piatt said.