(The Center Square) – Twenty-two attorneys general are pushing back against the Food and Drug Administration changing requirements for access to the abortion-inducing drug Mifeprex and its generic version, mifepristone.
The attorneys general sent a letter last month expressing their opposition to a new policy being implemented by the FDA ahead of a federal court in Dallas now expected to rule any day on doctors’ request that the court require the FDA to remove the drug from the market.
Led by Alabama Attorney General Steve Marshall, the coalition of Republican AGs sent a letter to FDA Commissioner Robert Califf arguing the FDA’s policy change is a “direct contravention of longstanding FDA practice and congressional mandate. The FDA’s rollback of important safety restrictions ignores both women’s health and straightforward federal statutes.”
The previous restrictions stipulated that mifepristone “could only be prescribed by a qualified physician and administered in a hospital, clinic, or medical office and only by or under the supervision of such a physician” due to health dangers it poses, the AGs argue.
The FDA first approved Mifeprex in 2000 and approved its generic version, Mifepristone Tablets, 200 mg, in 2019 to end an intrauterine pregnancy through ten weeks gestation. According to the CDC, 51% of abortions performed in 2020 were made possible using mifepristone around the ninth week of pregnancy.
Six months after the Supreme Court overturned Roe v. Wade, the FDA amended its risk evaluation and mitigation strategy, known as the Mifepristone REMS Program, stating, “REMS must be modified to reduce burden on the health care delivery system and to ensure the benefits of the product outweigh the risks.”
The Office of Legal Counsel of the Department of Justice also issued an opinion claiming the plain text of federal statute 18 U.S.C. § 1461 “does not prohibit the mailing, or the delivery or receipt by mail, of” abortion-inducing drugs, the AGs point out in their letter.
According to an FDA guidance published on its website, as of Jan. 24, 2023, “Mifepristone must be prescribed by a health care provider that meets certain qualifications and is certified under the Mifepristone REMS Program. … Mifepristone may only be dispensed by or under the supervision of a certified prescriber, or by a certified pharmacy on a prescription issued by a certified prescriber.”
It also states, the “FDA does not recommend buying Mifespristone online” or outside of its REMS program, “e.g. buying it online or personally transporting it from a foreign country.”
The AGs argue the policy change endangers the lives of women.
When the FDA first approved mifepristone, they argue, “the drug carried serious risks for women, including infection and bleeding. To mitigate the risk of harm to women, the FDA imposed several restrictions, which it began issuing as part” of REMS in 2007.
By expanding access to it, they argue, the “FDA has ignored its responsibility to protect health and safety by prioritizing a reckless pro-abortion policy over women’s health. Though there are risks to a woman of using these drugs at any point in pregnancy, abortion-inducing drugs are riskiest when used later in pregnancy. This means that accurately determining the date of pregnancy is critical for women’s safety. And that determination will be accurate only if made in-person via ultrasound.”
They wrote Califf, “To be crystal clear, you have not negated any of our laws that forbid the remote prescription, administration, and use of abortion-inducing drugs. The health and safety of our citizens – women and children included – is of paramount concern. Nothing in the FDA’s recent changes affects how we will protect our people.”
They sent the letter as a case in Dallas is expected to be ruled on any day seeking to ban the drug from the market.
The Alliance for Hippocratic Medicine sued the FDA last year asking a federal district judge in Dallas to rule that the FDA’s approval of mifepristone was illegal to begin with and to order the FDA to remove it from the U.S. market.
The case is before Judge Matthew Kacsmaryk with the U.S. District Court for the Northern District of Texas, a judge who’s ruled in favor of lawsuits filed by Texas Attorney General Ken Paxton and others over several unrelated issues.
A ruling on the case could be “as soon as Feb. 10 when it will be fully briefed,” according to CNBC.
“No matter how many backdoors Joe Biden attempts to go through to illegally force abortions in Texas, I will fight back to defend our pro-life laws and Texas mothers and children,” Texas AG Ken Paxton, who is part of the coalition, has argued.
Other attorneys general in the coalition opposing the FDA’s action represent the states of Alaska, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, Ohio, South Carolina, South Dakota, Tennessee, Utah, West Virginia and Wyoming.
