FDA Authority Under Scrutiny in Abortion Pill Case

The U.S. Supreme Court heard arguments challenging the Food and Drug Administration’s (FDA) regulation of mifepristone, the first pill pregnant women take in inducing chemical abortions.

The case, Food and Drug Administration v. Alliance for Hippocratic Medicine questions the legality of the FDA’s removal of basic patient safeguards for mifepristone since it was first approved for market use in 2000.

The Biden administration is appealing a decision by the Fifth Circuit on August 16, 2023, agreeing the FDA must restore safety protections. However, the three-judge panel disagreed with the lower court’s decision that the FDA was incorrect when it approved mifepristone in 2000. Also being considered are conscience protections for doctors.

Oral arguments before the Supreme Court took place on March 26.

High-Risk Drug

Since June 2022, when the Supreme Court affirmed the authority of individual states to regulate abortion in Dobbs. v. Jackson Women’s Health Organization, the abortion pill has taken on a new significance.

Just before opening arguments, the Guttmacher Institute released new data showing 63 percent of all abortions are now done chemically, a 10 percent increase since 2020.

Initially, the FDA required patients prescribed the drugs to have three in-person doctor visits and be screened for conditions and potential complications. Doctors were also required to advise on the time and place of use. Time is critical because there is a narrow window for pregnant women to use the pills safely.

In 2016, the Obama administration began stripping away those safeguards. The Biden administration doubled down during the COVID-19 pandemic. Physicians have argued chemical abortions are more dangerous than surgical ones.

Questioning Authority

The case calls into question several key points, including whether the FDA’s decision subverts conscience rights in health care and whether the FDA failed in its regulatory duties.

“The lower court’s decision merely restored longstanding and crucial protections under which millions of women used abortion drugs,” Alliance lawyers before the Supreme Court Justices. On April 7, 2023, U.S. District Court Judge Matthew Kacsmaryk of the Northern District of Texas stayed the FDA’s initial approval of mifepristone in 2000.

Arguing alongside Alliance has been Americans United for Life (AUL), a group representing 145 pro-life members in Congress from 36 states. AUL, which filed an amicus brief in the Supreme Court case AUL has called the FDA’s decision a subversion of statutory authority and said its promotion of access to chemical abortion drugs with barely existent regulations creates a significant danger to the health and safety of women and girls.

“The case before the Supreme Court exposes the impact of bad politics, money, and ideology,” AUL CEO John Mize told Health Care News. “The Biden administration has pushed the FDA way beyond the limits of its authority. The FDA has been weaponized to make abortion a norm, as easy as a telehealth visit, and a prescription for death.

“Over the last 20 years, the FDA has shredded its authority and reputation,” Mize said. “Commonsense protections from mifepristone must be restored, and Americans [must be] protected from a drug with a single, deadly purpose.”

Standing Debate

The issue of standing came up, over whether the plaintiffs can legally hold the FDA accountable.

Mize noted Chief Justice John Roberts’ questioning of the lawyers from the Biden administration and abortion drug manufacturer Danco.  Roberts asked what percentage of hurt and hospitalized women would be considered significant enough to warrant a lawsuit against the drug.  Defense counsel said there was no ceiling to the amount of harm that should be allowed.

Mize says he was also struck by the response from the Biden administration lawyer when questioned by Justice Clarence Thomas. If the Court found the Alliance ineligible to sue the FDA, Thomas asked, who would then have legal standing to challenge the agency?

Justice Alito followed a similar line of questioning, asking, “It doesn’t matter if FDA flagrantly violated the law, it didn’t do what it should have done, endangered the health of women, it’s just too bad, nobody can sue in court?”

In response to both Justices’ questions, the Biden administration counsel argued the FDA is untouchable.

“It is clear that the FDA’s removal of basic safety standards was reckless, leaving [emergency room] doctors to handle the fallout,” Alliance Defending Freedom (ADF) senior counsel Julie Marie Blake told Health Care News. “It is appalling that the FDA now says no one has the right to question that decision in court.”

Conscience Protections

Justice Brett M. Kavanaugh asked the FDA to confirm whether federal law protects the conscience right of a doctor to refuse to perform or assist in an abortion.

Biden administration counsel said “federal conscience protections provide broad coverage here,” adding, “The Church Amendments have the most comprehensive protection here, and we think that those amendments guard against the kind of injury that Respondents are asserting.” Mize says this could be the lynchpin in the decision. The Church Amendments were enacted about 50 years ago to protect the conscience rights of anyone asked to perform an abortion or sterilization.

“At the very least, even if the Alliance is unable to convince the Court to set aside the FDA’s chemical abortion rules at this time, it may still issue for the first time a resounding affirmation of their right not to participate in abortions.”

Justice Ketanji Brown Jackson asked Alliance where in the declarations “a declarant states that they attempted to object but were unable to.” Jackson said the remedy sought by Alliance has a “plainly overbroad scope” if exemptions to using and prescribing the drugs are already in place.

Decision Expected in June

AUL released a breakdown of the arguments made before the Court.

“The Supreme Court will spend the next few months deciding important issues about standing, administrative law, conscience rights, and health and safety safeguards for chemical abortion drugs,” states the analysis.