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FDA’s position on abortion pill in hands of Texas judge

U.S. District Courthouse in Amarillo, Texas (File photo)

AMARILLO, Texas (BP) — Pro-life advocates and others are awaiting a Texas judge’s ruling on whether an abortion pill approved by the Food and Drug Administration (FDA) in 2000 should be prescribed to women.

Alliance Defending Freedom (ADF) is representing Christian and pro-life medical professionals and advocates urging a federal district judge to issue an injunction suspending or revoking Mifepristone while a court challenge to the pill’s safety proceeds.

In the unprecedented challenge to the FDA approval process, the groups contend the FDA illegally approved Mifepristone in 2000 and charge that the drug is not safe for use.

The awaited ruling could impact the long-held FDA approval process used in vetting all drugs prescribed in the U.S., according to legal experts. It could also halt the method used for 53 percent of all abortions in U.S. facilities in 2020, according to the Guttmacher Institute.

Southern Baptist ethicists support the court challenge that could suspend the use of the abortion pill nationwide, including those where abortion is still legal post-Roe v. Wade.

“The FDA has failed to protect the health, safety and welfare of women by wrongfully approving these harmful chemical abortion drugs and stripping away any safeguards for their use,” Hannah Daniel, manager of public policy for the Southern Baptist Ethics and Religious Liberty Commission.

“The abortion pill not only ends the life of a precious, preborn child, but it poses serious health risks for women, who often take the drugs far away from available medical care.

“We urge the court to rule quickly to stop the widespread use of these harmful drugs for elective abortions to protect both women and their children.”

ADF Senior Counsel Erik Baptist argued against the drug in the Northern District Court of Texas on March 15 before Judge Matthew Kacsmaryk, appointed to the court in 2019 by then President Donald Trump.

“Today, we asked the court to put the health and wellbeing of women and girls first by undoing the harms that FDA has caused by illegally approving dangerous chemical abortion drugs and removing necessary protections,” Baptist said in a press statement.

“The FDA’s approval of chemical abortion drugs over 20 years ago has always stood on shaky legal and moral ground, and after years of evading responsibility, it’s time for the government to do what it’s legally required to do: protect the health and safety of vulnerable women and girls.”

The FDA lifted certain longstanding restrictions in 2021 on the use of the drug combination for allowing telehealth prescriptions and mail delivery, restrictions that were temporarily lifted during the COVID-19 pandemic.

“As we stated in court, the FDA never had the authority to approve these drugs and remove important safeguards, despite the substantial evidence of the harms women and girls who undergo this dangerous drug regimen could suffer.”

Kacsmaryk has said he will issue the ruling “as soon as possible.” But the immediate result of any ruling he issues in the case is not apparent, the Associated Press reported. FDA drugs generally are revoked through a process including public hearings and scientific deliberations than can extend for years.

Given under the brand name Mifeprex as the first dose in a two-drug combination to induce abortion, Mifepristone is also used for other purposes including treatment after miscarriage and, in another form called Korlym, to treat high blood sugar in people with a certain type of Cushing’s syndrome and type 2 diabetes, according to Medlineplus.com.

The abortion pill combination is available in 60 other countries, CNN reported.

In defending its approval of the drug, the FDA said the approval followed four years of deliberation and included extra safety restrictions, the Associated Press reported.

The FDA encourages women to seek medical care in the case of prolonged heaving bleeding and other complications.

“Although cramping and bleeding are an expected part of a pregnancy, rarely, serious and potentially life-threatening bleeding, infections, or other problems can occur following a miscarriage, surgical abortion, medical abortion or childbirth,” according to the FDA’s medication guide for the drug.

“Seeking medical attention as soon as possible is needed in these circumstances. Serious infection has resulted in death in a very small number of cases. There is no information that the use of Mifeprex and misoprostol caused these deaths. If you have any questions, concerns, or problems, or if you are worried about any side effects or symptoms, you should contact your healthcare provider,” the FDA guide says.

Challenging the abortion pill are the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical & Dental Associations, and doctors Shaun Jester, Regina Frost-Clark, Tyler Johnson, and George Delgado. They filed suit in November 2022.

Scott Lassman, a D.C. attorney who specialized in FDA regulatory issues, told the Washington Post, “The FDA is virtually never reversed by a court on scientific decisions because courts invariably recognize that they don’t have the expertise to make scientific decisions.”