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Thursday, Mar 16 2023

Full Issue

Judge Sounds Receptive To Challenge Of FDA's Abortion Pill Approval

In a Texas court Wednesday, U.S. District Judge Matthew Kacsmaryk heard arguments from a coalition of anti-abortion medical groups and doctors and the Justice Department in a case that could have broad repercussions for access to a medicated abortion in the U.S. The FDA's approval process for mifepristone and ability to mail the drug were considered during the hearing.

The federal judge who could upend access to a key abortion medication seemed open on Wednesday to the argument that the drug had not been properly vetted and could be unsafe 鈥 claims the Food and Drug Administration and leading health organizations strongly contest. While the antiabortion group challenging the drug acknowledged there is no precedent for a court to order the suspension of a long-approved medication, U.S. District Judge Matthew Kacsmaryk questioned whether mifepristone has met the rigorous federal standard necessary to be prescribed to patients in the United States. He asked a lawyer for the group whether the court could unilaterally withdraw FDA approval for a drug, and engaged with attorneys for both sides about whether mailing the pills should be prohibited because of a 19th-century law that bans sending articles 鈥渇or any indecent or immoral use鈥 through the Postal Service. (Stein, Kitchener and Marimow, 3/15)

During the four-hour hearing, U.S. District Judge Matthew Kacsmaryk appeared sympathetic to arguments from the lawyers for a coalition of anti-abortion groups called the Alliance for Hippocratic Medicine. Their goal in filing the suit was to overturn the Food and Drug Administration鈥檚 approval聽of the pills used to terminate pregnancies, which account for more than half of abortions in the U.S. (Victoria Lozano, Burns, Bendix and Siemaszko, 3/15)

Kacsmaryk has a number of options, from leaving the drug on the market to restoring rules around mifepristone that the FDA and the Biden administration have eased. Recent changes include allowing mifepristone to be mailed or dispensed by retail pharmacies. And in 2016, the agency decided to allow mifepristone to be used during the first 10 weeks of pregnancy, up from seven weeks. During the hearing, Kacsmaryk appeared to be considering whether he should order the drug to be taken off the market right away or order the FDA to take some other action. (Chappell and McCammon, 3/15)

Toward the end of the court hearing, which lasted more than four hours, Judge Kacsmaryk asked a lawyer for the plaintiffs, a coalition of anti-abortion groups and doctors, if they expected that 鈥渢he court itself can order a withdrawal or suspension.鈥 When the lawyer, Erik Baptist, said yes, the judge replied, 鈥淲hat gives the court that authority?鈥 At another point in the session, the judge asked a Justice Department lawyer representing the defendant in the case, the Food and Drug Administration, if the fact that 22 conservative states had written a brief supporting the plaintiffs鈥 case showed that revoking the abortion pill would be beneficial for public policy. The lawyer, Julie Straus Harris, replied, 鈥淎n injunction here would interfere with every state in the country鈥 and could make abortion access difficult even in cases of nonviable pregnancies and rape. That seemed to make an impression on the judge, who noted, 鈥淭his isn鈥檛 a case where we鈥檙e comparing 22 versus 28 states, but rather, all 50 states, especially in some of those other circumstances, right?鈥 (Belluck and McCann, 3/15)

The lawsuit was filed last year by the Alliance Defending Freedom against the FDA on behalf of three physician groups that belong to the Alliance for Hippocratic Medicine 鈥 the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians and the Christian Medical and Dental Associations 鈥 and four individual physicians. ... ADF鈥檚 attorneys argued that since 鈥減regnancy鈥 is not a disease, mifepristone should not have been considered eligible to be evaluated under the FDA鈥檚 accelerated approval program and is unsafe, per an Associated Press report. (Raman, 3/15)

Also 鈥

When the Supreme Court reversed federal abortion rights last June, Justice Samuel Alito鈥檚 majority opinion stressed that 鈥淚t is time to heed the Constitution and return the issue of abortion to the people鈥檚 elected representatives.鈥 Justice Brett Kavanaugh went further, separately emphasizing that the controversy would now be one for state officials and that judges would no longer undertake the 鈥渄ifficult moral and policy questions鈥 related to when a woman is allowed to end a pregnancy. But the drama Wednesday in a Texas courtroom over medication abortions demonstrates that judges remain at the center of access to abortion in America and reinforces the possibility that another battle over reproductive rights could soon land at the high court. (Biskupic, 3/16)

More abortion news from Utah, Tennessee, Wisconsin, and Ohio 鈥

Abortion clinics will be banned in Utah starting next year after Gov. Spencer Cox signed a bill Wednesday. The law will also impose other restrictions on abortion as the state鈥檚 trigger ban is held up in court. Rep. Karianne Lisonbee鈥檚, R-Clearfield, HB467, was among the more controversial bills passed this legislative session. It passed out of both the Utah House and the Senate along party lines. (Anderson Stern, 3/16)

Tennessee Republican lawmakers on Wednesday took another swing at adding a narrow exemption to one of the strictest abortion bans in the United States. Nearly a month ago, a Republican legislative panel defied political threats made by the state鈥檚 influential anti-abortion lobbying group and advanced legislation clarifying situations where abortion could be allowed in Tennessee. (Kruesi, 3/15)

Republicans who control the Wisconsin Legislature unveiled a bill Wednesday that would create rape and incest exceptions to the state鈥檚 1849 abortion ban and clarify when abortions that protect the health of the mother would be allowed. But the bill would not return the same rights that were in place under Roe v. Wade. The measure drew immediate bipartisan opposition, however. (Bauer, 3/15)

As proponents of abortion access start collecting signatures for a possible constitutional amendment, opponents announced a $5 million ad campaign to fight it. The new group, Protect Women Ohio, was formed in February to fight the abortion ballot campaign. Its board members include representatives from the Right to Life Action Coalition of Ohio, the Center for Christian Virtue and Ohio Right to Life. (Balmert, 3/15)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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