Multiple States Sue FDA for Allowing Abortion Pills to Be Sent by Mail

Mifepristone tablets are displayed in Rockville, Md., on April 13, 2023. Anna Moneymaker/Getty Images

Republican attorneys general in three states—Idaho, Kansas, and Missouri—have sued several Biden administration agencies, alleging that they unlawfully approved shipment of dangerous abortion drugs by mail while rolling back key safety precautions, exposing women and girls who get chemical abortions to potential harm.

Missouri Attorney General Andrew Bailey said Monday that his office has filed a lawsuit against the Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) over the agencies’ illegal approval of shipments of chemical abortion drugs (mifepristone and misoprostol) by mail across the United States.

“Unelected federal bureaucrats do not have the statutory authority to approve the shipment of these dangerous chemical abortion drugs in the mail,” Mr. Bailey said in a statement.

According to health officials, mifepristone blocks the hormone progesterone that is needed for a pregnancy to continue. When used with misoprostol, the pill is used to end a pregnancy through 10 weeks.

The lawsuit alleges that the FDA violated multiple federal laws by approving the “untested” abortion drugs, risking potential harm to women and girls who undergo chemical abortions. It seeks to restore safeguards around the use of the drugs, including requiring that they be dispensed in-person by a physician.

The FDA told The Epoch Times in an emailed statement that it would not comment on ongoing or pending litigation.

Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a chemical abortion, are seen at the Women's Reproductive Clinic, in Santa Teresa, N.M., on June 17, 2022. Robyn Beck/AFP/Getty Images

More Details

The lawsuit asks the court to block the 2016 rollback of most of the safety precautions the FDA had put in place when it first approved mifepristone in 2000. It also calls on the judge to halt the FDA’s approval in 2019 of generic mifepristone, and to put a freeze on the 2021 and 2023 policies that allowed abortion drugs to be sent by mail, which would effectively restore an in-person dispensing requirement.

“The FDA’s guidance is not only unlawful, but would cost the lives of both women and their unborn children. I am proud to be leading a coalition of states to halt the FDA’s illegal federal overreach in its tracks,” Mr. Bailey said.

While the lawsuit names the FDA and HHS (along with their respective staff members) as defendants, the complaint refers to all the defendants collectively as the “FDA.”

Joining the lawsuit are Idaho Attorney General Raul Labrador and Kansas Attorney General Kris Kobach, who along with Mr. Bailey have asked to join the existing lawsuit against the FDA brought by the Alliance for Defending Freedom (ADF) on behalf of the Alliance for Hippocratic Medicine, and others.

“The FDA’s illegal actions have inflicted harm on these states, in addition to the harms suffered by ADF’s doctor and association clients, and recent actions have compelled them to seek to join our effort in holding the FDA accountable,” ADF senior counsel Erin Hawley said in a statement.

“The FDA failed to do its job, and every court so far has agreed that the FDA acted unlawfully in removing crucial safeguards for women and authorizing dangerous mail-order abortions,” she added.

The Louisiana-based U.S. Court of Appeals for the 5th Circuit has ruled that the FDA must restore its safeguards for the abortion drugs and not let them be shipped by mail across the country.

However, the Department of Justice and the drug maker, Danco, have both filed petitions with the Supreme Court and asked the justices to hear their case.

“The Guardian” or “Authority of Law" statue by James Earle Frasier in front of the U.S. Supreme Court in Washington on Sept. 28, 2020. Al Drago/Getty Images

Court Battles

In 2000, FDA approved the abortion pill for ending pregnancies at up to seven weeks gestation or less. In 2016, the FDA extended the use in pregnancies at up to 10 weeks gestation. Later, policies adopted by the FDA in 2021 and 2023 allowed mifepristone to be sent by mail or courier.

Since the U.S. Supreme Court overturned its 1973 Roe v. Wade decision, the two-drug combination has been increasingly prescribed and has become the most common method of abortion in the United States.

The FDA’s decisions regarding the drugs have been challenged in court, with ADF attorneys filing the original lawsuit (pdf) against the FDA in a Texas court in 2022.

In April 2023, the Texas judge who was hearing the case issued a ruling (pdf) that found that the FDA was wrong to approve the abortion pill and that the agency had improperly lifted restrictions on access to the drug.

Judge Matthew Kacsmaryk, an appointee of President Donald Trump, said in his ruling that the FDA “acquiesced on its legitimate safety concerns—in violation of its statutory duty—based on plainly unsound reasoning and studies that did not support its conclusions.”

“There is also evidence indicating [the] FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion.”

The FDA’s failure to impose restrictions on the use of the drug “resulted in many deaths and many more severe or life-threatening adverse reactions,” he wrote.

Appeals

The Department of Justice (DOJ) appealed Judge Kacsmaryk’s decision, sending the case to the 5th Circuit Court of Appeals, which upheld most of the Texas judge’s order.

The DOJ appealed that decision to the Supreme Court, which granted an emergency request to allow the abortion pill to remain accessible amid the legal battle.

A number of doctors’ groups subsequently filed briefs with the Supreme Court asking the justices to strike down the FDA’s approval of mifepristone.

The Alliance for Hippocratic Medicine and other physician groups stated in a recent Supreme Court petition that the health agency approved the drug under a process that was designed for drugs meant to treat illnesses. They said pregnancy is a “natural process that many women experience,” and not an illness.

“The FDA’s recent actions on chemical abortion drugs have harmed the health of countless women and girls and undermined the rule of law by illegally removing every meaningful safeguard from the chemical abortion drug regimen,” the Alliance said in a statement.

“The FDA’s unprecedented actions did not reflect scientific judgment but rather revealed politically driven decisions to push a dangerous drug regimen without regard to women’s health. We are urging the Supreme Court to deny the Biden administration’s request to overrule the decision of the Louisiana-based U.S. Fifth Circuit Court of Appeals,” it stated.

Recently, multiple medical groups submitted amicus briefs to the Supreme Court and argued the need for the court to review the 5th Circuit’s order.

“The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting the industry’s reasonable investment-backed expectations. Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards,” the Pharmaceutical Research and Manufacturers of America wrote in a brief.

In six of the 15 states where access to abortion pills is restricted, an in-person physician visit is required.

In states with abortion pill restrictions, health providers could face penalties, such as fines or license suspension, for attempting to send pills through the mail.

Jack Phillips contributed to this report.