Conservative group sues FDA to revoke abortion pill approval

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Abortion haters sued the Food and Drug Administration in Texas federal court on Friday seeking to overturn the decades-old approval of mifepristone, the drug used in medical abortions.

Alliance Defending Freedom, a conservative group that has been embroiled in anti-abortion litigation, filed the lawsuit in Amarillo on behalf of four anti-abortion medical organizations and four doctors who had treated patients with the drug. The lawsuit also named the Department of Health and Human Services as a defendant.

The lawsuit claims that the FDA lacked the authority to approve the drug, did not study the drug adequately, and that the drug is unsafe. More than half of abortions in the United States are performed using mifepristone.

The “FDA failed American women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States,” the lawsuit said. The lawsuit said the agency erred in approving the drug under an expedited process intended to speed up consideration of therapies for life-threatening diseases, not a condition like pregnancy.

“Pregnancy is not a disease and chemical abortion drugs provide no therapeutic benefit – they end the baby’s life and pose serious and life-threatening complications for the mother,” Julie Marie Blake said., Lead counsel for Alliance Defending Freedom, said in a statement.

Alliance Defending Freedom attorneys were part of the legal team that helped defend Mississippi in the case that led the Supreme Court in June to overturn Roe v. Wade, which guaranteed the right to abortion.

The Biden administration and abortion rights advocates have denounced the lawsuit.

“For decades, women in this country have had access to FDA-approved medical abortion as a safe and effective option,” HHS said. “As [HHS Secretary Xavier Becerra] said, denying women access to the essential care they need is downright dangerous and extreme.

The FDA said it does not comment on ongoing litigation.

Mifepristone blocks the hormone progesterone, which is needed to maintain pregnancy. The FDA approved the drug as safe and effective for the first seven weeks of pregnancy about two decades ago, then later extended it to 10 weeks. The drug is sometimes used “off label” after that. Patients follow the use of mifepristone with misoprostol, which causes emptying of the uterus.

Greer Donley, an associate professor of law at the University of Pittsburgh School of Law who has written extensively on the abortion pill, denounced the group’s safety claims as “ridiculous”.

“Mifepristone is one of the safest drugs on the market, safer than Viagra and penicillin,” Donley said. “We have a lot of studies and a lot of data on this.”

Donley said the legal claims in the lawsuit were “really weak”. She said the agency approved the drug under the fast-track because it allowed the FDA to place restrictions on its use — restrictions that she and other rights advocates have been following. abortion think they should be eliminated.

Donley said she doesn’t know of any other lawsuits that tried to overturn the FDA’s approval of the abortifacient drugs.

Loren Colson, an Idaho family physician and member of Physicians for Reproductive Health said mifepristone is “an incredibly safe drug.”

“It’s been well-researched and much safer than a lot of stuff you can find over-the-counter,” Colson said. “If they’re trying to argue safety, they have very little ground to stand on. It’s just a clear and blatant attack on abortion.

The groups behind the Texas lawsuit are the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians and the Christian Medical & Dental Associations.

Medical abortion – the most common method of abortion in the United States – has become an increasingly contentious issue since Roe vs. Wade was reversed in June.

As states have decided to restrict or ban abortion, women have increasingly turned to the use of abortion pills. Abortion rights advocates say abortion opponents view the drugs as a threat to their efforts to ban abortion.

State abortion bans are interpreted as bans on both medication and surgical abortions. Some of the bans are embroiled in legal battles.

The reversal of Roe vs. Wade after almost 50 years should trigger a new set of legal challenges for which there is little precedent, observers say, further disrupting the country’s bitter political landscape and deepening the chaos as Republican-led states move quickly to restrict access to reproductive care.

The Texas lawsuit challenges the FDA’s relaxation of restrictions on the abortion pill over the years, including the agency’s 2016 decision to say the drug could be used for 10 weeks of pregnancy. Last December, the FDA said it would allow abortion pills to be mailed in the mail where permitted by state law. Previously, pills could not be mailed, although this rule was temporarily suspended due to the pandemic.

At the same time the FDA is being sued by abortion opponents, it is also being criticized by abortion rights advocates who say the agency is moving too slowly to lift remaining restrictions on pill access. abortive.

On Friday, nine Democratic senators urged the agency to quickly complete work to permanently allow mail-order delivery and make other changes that would make the drug easier to access.

In a letter to FDA Commissioner Robert M. Califf, lawmakers said, “As states implement new restrictions, it is more important than ever that you take immediate action to expand access to abortion medicated.

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