A Texas High-Energy Judge Shuts Out the Food and Drug Administration’s Error on Mifepristone

A federal judge in Texas has taken a shocking and irresponsible action: invalidating the Food and Drug Administration’s approval of mifepristone, a medication used safely by hundreds of thousands of women each year to help terminate pregnancies as part of a two-pill regimen. An agency drug approval that was based on a thorough review of scientific evidence was thrown out for the first time in history, but the full backing of major medical organizations was retained.

The intensity of the storm Kacsmaryk whipped up was evident in heated rhetoric between Republicans and Democrats on Sunday. After the administration appealed to stop the suspension from taking effect on Friday, the Health and Human Services Secretary promised that women would have safe and effective medication.

The FDA could be punished by the House if they took such a step, said Texas Republican Rep. Tony Gonzalez. “If the administration wants to … not live up to this ruling, then we’re going to have a problem,” he said. “It may come (to) a point where House Republicans on the appropriation side have to defund FDA programs that don’t make sense.”

Such a move could severely impede a critical arm of the American health care system and deepen acrimony surrounding the regulatory approval process, which was attacked by conservatives amid skepticism of the Covid-19 vaccine.

“It’s important that we have real discussions on women’s health care and … get off the abortion conversation,” Gonzales told Bash. Women have a lot more issues than just abortion. Let’s have those real conversations, and let’s talk about the other things that are happening in this world.”

President Joe Biden decried the decision as an “unprecedented step in taking away basic freedoms from women and putting their health at risk”, noting his administration would continue to fight it in court. He also called on voters to elect lawmakers who would pass explicit protection for abortion access, calling it “the only way” to stop future decisions along the same lines.

A Texas judge ruled on Friday that the Food and Drug Administration has a history of approving drugs that aren’t in line with current science, just as a Washington state judge ruled that the FDA doesn’t follow proper procedure when it approves drugs that have already been approved.

It makes sense to ask if the courts should have a say in the scientific decision-making of the F.D.A. In fact, judges do have an important job: protecting the ability of the agency to use science and expert judgment to support the health of the American people. The Texas decision is a perversion of this role and, by undermining the F.D.A., represents a threat to the safety of millions of Americans.

Monday is the day when the F.D.A. finds itself in court. Also, Tuesday, Wednesday, Thursday and Friday. Sometimes the weekends, too. The agency’s large stable of dedicated attorneys defends its actions on a multitude of issues. These include routine administrative matters such as whether the agency moved too fast or too slow on a generic drug approval or whether the agency has missed regulatory deadlines.

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Drug Abortion is a procedure that accounts for more than half of US abortions and has been disputed by some states. The office of the governor of California said that it would not support the ruling because it stripped away fundamental freedoms. Likewise, New York Attorney General Letitia James issued a statement that “abortion continues to be legal in New York and New York will remain a safe haven for anyone seeking abortion care.”

The case is also notable for relying on the Comstock Act, a 150-year-old obscenity law that, among other things, bans the shipping of materials related to abortion. The opinion approvingly interprets its ban on any “article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use it or apply it for producing abortion” as a ban on mailing mifepristone even for legal abortions. “The statute plainly does not require intent on the part of the seller that the drugs be used ‘unlawfully,’” Kacsmaryk writes. There is a sign that long-dormant obscenity rules are being resurrected following an unsuccessful attempt to ban books in Virginia.

But in the short term, the ruling’s potential effects are muddy and reliant on the Fifth Circuit Court of Appeals, which could reverse the stay. (The Fifth Circuit is notably the one that allowed a ban on internet moderation to stand in 2022.) In February, members of the nonprofit Women’s Law Project argued that the FDA had substantial power to limit the ruling’s effects even if it were allowed to stand. Its response may determine whether manufacturers and sellers of the drug maintain patients’ access to the pill in the face of legal uncertainty.

But in U.S. states where second trimester abortion is allowed, Brandi says, doctors will typically recommend a procedural abortion in a hospital rather than a medication-based abortion to end pregnancies after 12 weeks. That’s because second trimester misoprostol-only abortions can involve more bleeding and prolonged cramping. In states where patients don’t have other legal options, the doctors would most likely only recommend the drug in the second trimester.

For misoprostol-only abortion, it’s less clear cut. There is proof that the regimen can end pregnancies up to 22 weeks. That’s according to one study that looked at patients having self-managed abortions, without the direct involvement of a doctor in countries that have had restrictive abortion laws.

Multiple organizations, like the American College of Obstetricians and Gynecologists and the World Health Organization, say the one-medication protocol is an acceptable choice, particularly when mifepristone isn’t available.

If patients experience heavy or prolonged bleeding – spotting that persists for over 2 weeks, for example, or bleeding so heavy they soak through more than two pads an hour for over two hours – they might need a procedure to complete the abortion.

Infectious if you take misoprostol, but not before 12 weeks after taking it: How to get your prescription before taking it

A prolonged fever above 100.4 degrees Fahrenheit is also a reason to seek medical care. While low-grade fevers and chills are an expected side effect of misoprostol and aren’t life threatening, if a fever persists for more than 24 hours after taking misoprostol, it could be a sign of infection.

The Food and Drug Administration has approved the two-drug regimen to end pregnancies up to 10 weeks gestational age, but the World Health Organization endorses it up to 12 weeks. They’re less likely to be effective after that.

In states where abortion is legal in the first trimester, patients can speak to a health care provider and get a prescription for medication abortion via telehealth abortion companies, in-person at clinics that provide abortion like Planned Parenthood, and at many general OB/GYN and family medicine clinics.