12 states sue FDA seeking to lift specific restrictions on abortion pill

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Attorneys general of a dozen Democratic-controlled states sued the Food and Drug Administration on Friday, asking a judge to lift special restrictions that the federal agency had long imposed on the first two drugs used in medication abortions. Have done

The lawsuit, filed in a federal district court in Washington state, comes at a tense moment in the battle over the legal status of abortion pills, which are used in more than half of abortions in the United States. A federal judge in Texas is expected to issue an order soon in a case filed by anti-abortion groups that seeks to overturn the FDA’s approval of a single abortion pill, mifepristone, and have it removed from the market.

The potential outcome of the Texas case has rattled the reproductive health community out of concern that the judge, a Trump appointee who is politically conservative and wrote an article criticizing Roe v. Wade, one could effectively issue an order blocking access. Mifepristone across the country. Such a ruling would be immediately appealed, but if it ultimately stood, it would have far-reaching effects, affecting states where abortion is legal, not just states where abortion is already banned.

The new lawsuit, filed by 12 states, does not address the possible consequences of the Texas case, but requests that the judge’s ruling in the Washington case include orders that would effectively violate steps the Texas judge could take. Can While the Washington case primarily asks the court to order the FDA to eliminate a framework of additional restrictions applied to mifepristone, the suit also asks the judge to declare that the FDA’s “approval of mifepristone is valid and is legal” and to the FDA “to” take any action to remove mifepristone from the market or reduce its availability.”

Amit Sarpatwari, assistant professor of medicine at Harvard Medical School and attorney, said the timing and content of the lawsuit were strategic.

“It is a legally and politically sensible move to file a complaint now,” he said. “If you have a federal judge in one jurisdiction saying that the approval was valid, and actually preventing the FDA from taking action to restrict access, that stands in exact conflict with the Texas judge’s presumption. That would actually void the approval. The drug.”

Dr. Sarpatwari, an expert on FDA regulations, said if two federal decisions conflict, that gives the federal government a basis to say, ‘Look, I have two courts saying fundamentally different things. have been, and the best we can do now is to do nothing. He added that this could result in both cases coming before the Supreme Court and protected access to mifepristone pending the High Court’s decision.

Kristin Beneski, Washington state’s first assistant attorney general, said the goal of the new lawsuit is to “protect and expand medication abortions.”

“It is not right for a judge in Texas to decide for all Americans whether they can access the gold standard of care for early pregnancy termination,” he said.

The FDA declined to comment on the new case, saying it does not discuss pending litigation.

In the Texas lawsuit, anti-abortion groups claim the FDA improperly approved mifepristone and ignored safety risks. In a filing in that case, the FDA disputed those claims, saying that revoking its drug’s approval “would cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.” “

The filing on Friday was led by the attorneys general of Washington and Oregon, who were joined by their counterparts in Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont. The lawsuit is aimed at a special framework of restrictions and oversight that the FDA currently applies to only about 60 drugs. Called the Risk Evaluation and Mitigation Strategy, or REMS, it has applied to mifepristone for about a dozen years.

Initially, it was much more restrictive than it is now, with regulations requiring that patients obtain mifepristone in person from a health care provider, although they could take the drug at home or anywhere they wished.

In recent years, the FDA has extensively reviewed new data on mifepristone and removed many restrictions, including the individual requirement. It now allows the drug to be shipped to patients by mail and recently authorized retail pharmacies to dispense the drug if they become specially certified.

The agency’s remaining specific requirement for mifepristone is that patients sign an agreement certifying that they have chosen to take the drug to terminate a pregnancy. Providers and pharmacies must become certified, which is not difficult but does involve some administrative and logistical steps.

Ms. Beneski said the certification requirements and agreement that patients must sign are cumbersome, present a false sense that the drug is unsafe and have scared away many providers who would otherwise prescribe mifepristone, limiting access to medication abortion. do. The requirements, which generate lists of certified providers, leave providers concerned about their privacy in a political climate where, he said, “they are really concerned about being targets of violence and harassment.”

“We are not arguing that the FDA should not have approval authority over mifepristone, only that the REMS system is unnecessary for this drug and creates unnecessary risk for providers and patients in the current legal landscape,” Ms. Beneski he said. “Those risks are real, and they need to be addressed.”

Mifepristone is also used to treat miscarriage, and the FDA ban also applies to patients who must certify at the time of signing the agreement that they have “decided” to end their pregnancy, the lawsuit states. Says

While abortion opponents claim there are serious safety risks from medication abortion, mainstream medical organizations and abortion rights groups have long said that specific restrictions on mifepristone are unnecessary, citing years of data on safety and efficacy. But, in an unusual twist, since the Supreme Court overturned the Roe v. Wade decision, some reproductive health legal experts have argued that officially maintaining the REMS framework is beneficial in the fight against state laws that restrict abortion. aim to ban or restrict.

Their argument is that the FDA’s decision to impose specific restrictions on mifepristone and to gradually reduce some of them as evidence of safety and efficacy shows how careful and rigorous the federal government has been with the drug and that Strengthens the case that the FDA has final authority over the states. This argument was recently made in two lawsuits that challenge the constitutionality of state abortion bans and restrictions – one filed in West Virginia by a mifepristone manufacturer and the other in North Carolina by an obstetrician-gynecologist.

On Friday, however, many of those experts said they supported the new lawsuit’s effort to remove additional restrictions. David S. Cohen, a law professor at Drexel University, said lawsuits claiming that the FDA’s rules pre-empt state laws “are ironically helped by these restrictions,” adding that those restrictions are needed for the cases to succeed. Not there.

Dr. Cohen called the new lawsuit a “great strategy,” adding that “removing the unnecessary restrictions the FDA has placed on the drug — restrictions not supported by any science — is one of the top priorities.”

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