The United States Supreme Court heard oral arguments Tuesday in a case that could further impact a woman’s right to choose on the heels of the overturn of Roe v. Wade.
A ruling in the case, called FDA v. Alliance for Hippocratic Medicine, is set for June. The case centers on the use of mifepristone, sometimes called the abortion pill. However, it may also impact the Food and Drug Administration’s regulatory authority.
The FDA is seeking to overturn a lower court ruling that limited its regulatory review of medications and severely restricted the use of mifepristone.
The Issue of Standing
Though it is hard to predict what the court may determine, there did seem to be significant concern by justices about the standing of the groups challenging the use of mifepristone and FDA oversight.
Standing in the legal system refers to the right of a person or group to file a suit. One of the principles for determining standing is whether a party has or will sustain injury from the action they are challenging.
Justice Amy Coney Barrett, one of the five who voted to overturn Roe, grilled Alliance lawyer Erin Hawley. Barrett noted that Alliance members included retired doctors and dentists. As a result, most members of the group would not be involved abortion treatment.
When pressed, Hawley, a law professor and wife of Missouri Senator Josh Hawley, identified seven members of the Alliance who were OB-GYNs. Brett noted that none of them had been asked to assist in abortion care.
Barrett further asked if a doctor could refuse to provide abortion treatment. U. S. Solicitor General Elizabeth Prelogar answered that, “The federal government has never taken the position that EMTALA (Medical Treatment and Active Labor Act) would override an individual doctor’s conscience objections,”
Medication Abortions
Abortions were performed in the U. S. healthcare system solely by surgical procedure until 23 years ago when the FDA approved the use of mifepristone. At the time, the FDA allowed the use of the abortion pill within the first seven weeks of pregnancy. However, the agency later pushed that limit to 10 weeks.
The FDA also approved delivery of the pill by mail and allowed its use through telemedicine. The court’s decision may restrict how the medication is delivered or used. In fact, it could ban mifepristone altogether.
Coincidentally, two of the largest drugstore chains in America were approved this month to carry mifepristone. Walgreens already offers the medication in states where abortion is legal. Also, CVS announced it is following suit. Neither of the pharmacies plan to offer the pill by mail.
How Abortion Pills Work
Abortions can be done in the first trimester with medications.
Mifepristone is only used is for abortions. Another medication that is used for abortions is misoprostol. However, it is not involved in the current supreme court case.
Mifepristone blocks the function of progesterone in the uterus. As a result, the uterus sheds its lining, as does during a period, stopping the pregnancy.
Misoprostol, referred to as Cytotec, makes the uterus contract. That results in bleeding and cramping and expels pregnancy tissue through the vagina
Medication Abortions Increasing
Over five million women have used mifepristone for abortions since its FDA approval in September 2000. In 2023, 63 percent of abortions in the U. S. healthcare system were performed via mifepristone, according to a report from Guttmacher Institute. That is a seven percent increase from 2020. The Guttmacher research does not include self-managed medication abortions.
However, a new study published Monday in the JAMA Network shows that the distribution of abortion medication increased after the Dobbs ruling.
Specifically, 27,828 more abortion pills were distributed in the six months after Roe was overturned versus the six months prior.
Price of Abortions
Most people pay for abortions out of pocket.
In 2021, the median cost of an abortion in the first trimester was $568 for a medication abortion versus $625 for a surgical procedure, according to KFF. Costs were higher in the second trimester, rising a median of $775.
Second trimester abortions cost more because a surgical procedure is required. In addition, there may be a need for transportation, ledging, childcare and lost wages.
The KFF study reports that lower income people are less able to afford the cost of an abortion. However, there are regional and local abortion funds that may help with costs. The National Network of Abortion Funds maintains information on 100 of these funds across the country.
Safety and Obscenity
While accessibility to mifepristone hangs in the balance, the court case is also a challenge to the authority of the FDA.
Plaintiffs in the case maintain that mifepristone presents health risks. However, the FDA refers to data showing the abortion pill is 99.6% effective in terminating pregnancies. Further the agency maintains that complications from mifepristone are lower than Tylenol.
Further, the suit alleges that the FDA fast tracked approval of mifepristone. However, the FDA denies that claim. In addition, the plaintiffs argue that allowing the medication to be shipped by U. S. mail violates the Comstock Act of 1873.
That law governs how the postal service ships contraception and obscene items.
Impact on FDA
A ruling against the FDA could open the door to challenges regarding other approved medications. That could include everything from contraception to vaccines and hormone therapies used in gender affirmation.
In a brief to the court, pharmaceutical companies and investors warmed the case could lead
to an avalanche of baseless legal challenges. Further, it could hamper future drug development.
A ruling that shackles the FDA “will invite a flood of meritless challenges to the FDA’s drug safety and efficacy decisions, including those brought by parties with no concrete interest at stake,” argues the brief.
The brief also contends that a decision against the FDA will “create chaos in the processes for drug development, approval, and modification. That decision casts a shadow of lasting uncertainty over every FDA approval and invites spurious lawsuits challenging FDA’s settled safety and effectiveness determinations after the fact.”
Roe to Now
The road to the Alliance case began with the overturn of Roe v. Wade.
Anti-abortion groups began challenging the Roe decision almost as soon as it was issued.
Roe was a landmark 1973 case that decriminalized abortion nationwide. The current Supreme Court reversed Roe in the June 2022 case of Dobbs v. Jackson Women’s Health Organization.
Dobbs did not ban abortion nationwide. It left states to set their own laws on the procedure.
Currently, 16 states have a total ban on abortion. Another 26 states banned abortion after a specific time in pregnancy. In addition, Dobbs does not restrict travel from one state to another to obtain an abortion.
Regardless of the court’s decision in FDA v. Alliance for Hippocratic Medicine, legal battles over abortion are far from settled.
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