Texas court invalidates FDA approval for abortion pills

A federal judge in Texas has issued a preliminary ruling invalidating a 23-year Food and Drug Administration (FDA) approval of mifepristone in abortion pills. This is an unprecedented order that could make it harder for patients to perform abortions in states where abortion is legal, not just where they are trying to restrict it. Writes about it The New York Times.

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The drug will continue to be available, at least in the short term, as Judge Matthew Kaczmarik suspended his own order for seven days to allow the FDA to appeal.

Less than an hour after Judge Kachsmarik's decision, a judge in Washington State ruled in another case that contradicted the Texas decision. He directed the FDA not to make any changes to the availability of mifepristone in the 18 states that filed the lawsuit.

Conflicting rulings by two federal judges, both preliminary injunctions issued before all cases are heard, appear to be creating a legal standoff that is likely to reach the Supreme Court.

US President Joe Biden said his administration will fight the Texas ruling.

“This isn’t just about women in Texas,” he said. “If the ruling remains in effect, it will prevent women in every state from accessing the drug, regardless of whether abortion is legal in the state.”

On April 7, the Justice Department filed a notice that it was appealing the Texas decision.

"Today's decision overturns the FDA's expert opinion more than two decades ago that mifepristone is safe and effective," Attorney General Merrick Garland said, adding that the Department of Justice will ask that the decision be suspended while the appeal is pending. . He said the department is reviewing the Washington case.

The lawsuit, filed by a coalition of anti-abortion groups and physicians, seeks to end more than 20 years of legal use of mifepristone, the first pill in a two-drug IBA regimen.

The lawsuit in Washington State was filed by 18 Democratic attorneys general who challenged the agency's restrictions on prescribing and purchasing mifepristone. In a preliminary injunction in the case, Judge Thomas Rice, appointed by President Barack Obama, prohibited the agency from taking "any action to withdraw mifepristone from sale or otherwise make the drug less available."

Medical abortion is the method used by more than half of the ISPs in the United States. The lawsuit alleges that the FDA did not properly consider the scientific evidence and did not follow proper protocols when it approved mifepristone in 2000 and has ignored the drug's safety risks ever since.

On the subject: Idaho woman bled for 19 days after miscarriage, but doctors were afraid to help her because of abortion law

The FDA and the Department of Justice vigorously contested the claims in the lawsuit and said the federal agency's rigorous reviews of mifepristone over the years have repeatedly supported the decision to approve mifepristone, which blocks a pregnancy-promoting hormone.

The FDA said: “The FDA reaffirms its determination that mifepristone is safe and effective under approved conditions of use for medical abortion of early pregnancy, and believes that patients should have access to FDA-approved drugs that the FDA has determined are safe and effective. effective for their intended use."

In a 67-page Texas ruling, Judge Kaczmarik appeared to agree with virtually all of the claims of anti-abortion groups, and repeatedly used anti-abortion language to refer to medical abortion as a "chemical abortion" and refer to the fetus as an "unborn person" or "unborn child." .

“The Court does not question the FDA's reckless decision-making,” the judge wrote. “There is also evidence to indicate that the FDA has faced significant political pressure to abandon proposed precautions in order to better advance the policy goal of expanding access to chemical abortion.”

A lawyer for Danco Laboratories, which makes a branded version of mifepristone called Mifeprex, strongly disagreed with the judge's decision. The company joined the lawsuit on the side of the FDA.

"The court's ruling rewrites the facts and the law to set out a preferred narrative that goes against established legal principles and Mifeprex's well-established safety profile," attorney Jessica Ellsworth said in a statement.

Danco said it is appealing the decision.

Eric Baptiste, an attorney for the anti-abortion groups that filed the lawsuit in Texas, called the decision "a significant victory for the doctors and medical associations we represent, and more importantly, the health and safety of women and girls." Baptiste, senior adviser to the Freedom Defense Alliance, a conservative Christian legal organization, said: “By illegally approving dangerous abortion chemicals, the FDA is putting women and girls at risk. It is time to hold the agency accountable for its reckless actions."

Legal experts said that even if the Texas decision is ultimately upheld, there will be few legal options that would allow mifepristone makers to continue supplying the drug and providers to continue prescribing it to patients.

Shortly after the ruling was made, the chief executive of GenBioPro, one of two U.S. manufacturers of mifepristone, issued a statement saying the company was reviewing both judges' decisions.

"We will take all necessary steps to legally make mifepristone available to as many people in the country as possible," CEO Evan Masingill said in a statement.

And if legal access to mifepristone is blocked, some providers plan to provide only a second abortion drug, misoprostol, which is used safely on its own in many countries where mifepristone is less available. Misoprostol is a drug approved for other medical purposes. It causes miscarriage-like contractions and is considered slightly less effective on its own than when combined with mifepristone, and is more likely to cause side effects such as nausea.

In the Texas lawsuit, the plaintiffs are seeking a ban on the use of misoprostol to terminate a pregnancy, among other things, but their request for a preliminary injunction concerns mifepristone.

Since last year's Supreme Court ruling overturned the national right to NPI, the pills used for medical abortion have increasingly become the subject of political and legal battles. Some conservative states, in addition to banning or restricting abortion in general, have begun considering legislation specifically targeting the PPI. And several recent lawsuits have been filed in an attempt to maintain or expand access to medical abortion.

The lawsuit, filed in Washington state, was intended to be a direct challenge to the Texas case. Democratic attorneys general filed the case in late February, the first day Judge Kaczmarik could issue a ruling. While its primary demands were aimed at eliminating the system of additional restrictions that the FDA has long placed on mifepristone, the suit also asked the judge to declare that "the FDA's approval of mifepristone is lawful and valid" and to order the FDA "not to accept any measures to remove mifepristone from the market or reduce its availability."

Washington Attorney General Bob Ferguson described the lawsuit filed by him and other attorneys general as "the opposite of what's going on in Texas."

He noted: “Therefore, there is the potential for two decisions or judges that, in essence, contradict each other. In other words, one judge in Texas could potentially say, “Hey, I'm banning mifepristone nationwide,” and a judge in Washington state, in the case of 17 other states, could say, “No, no, not only will it be available; expand access to it."

The FDA regulates the use of mifepristone more strictly than other drugs and regularly reviews the evidence for its safety and effectiveness.

Over the course of a decade, the agency introduced additional restrictions and controls on the drug. This scheme, called the Risk Assessment and Mitigation Strategy, or REMS, has only been used for 300 other drugs, of which it currently covers only 60.

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In recent years, the FDA has carefully reviewed new data on mifepristone and lifted several restrictions, including the requirement that patients receive the drug in person from a doctor.

Some of the same anti-abortion organizations that filed the lawsuit in Texas had previously filed civil petitions in 2002 and 2019 against the FDA's handling of mifepristone. Both were rejected as unfounded. And a 2008 audit by the Government Accountability Office found no irregularities in the FDA's approval of mifepristone.

Legal experts said the decision was the first time a court has taken a decision to remove a drug from the market over objections from the FDA, and that if the decision stands, it could have implications for federal authorities to regulate other types of drugs.

In a statement, Biden said, "If this decision remains in place, there will be virtually no FDA-approved drugs that are immune to this kind of political and ideological attack."

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