The Supreme Court on Friday ruled that the abortion drug mifepristone can remain on the market with no new restrictions while a  case  against  FDA's approval of the drug plays out.

Background

Earlier this month, Judge Matthew Kacsmaryk issued a ruling invalidating FDA's approval of mifepristone, arguing the agency didn't adequately review scientific evidence or follow the proper protocols when it approved the drug in 2000.

In  response  to Kacsmaryk's ruling, more than 200 pharmaceutical companies signed a  statement  calling for the reversal of the decision. More than 400 leaders from some of the most prominent companies in the drug and biotech industry criticized Kacsmaryk for issuing the ruling, noting that he has "no scientific training" and warning that the decision has "undermined the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American."

In addition, "[t]he decision ignores decades of scientific evidence and legal precedent," the drugmakers wrote. "Judge Kacsmaryk's act of judicial interference has set a precedent for diminishing FDA's authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry," they wrote.  

Meanwhile, in a lawsuit filed in Washington state by 18 Democratic attorneys general challenging FDA's restrictions on prescribing and dispensing mifepristone, Judge Thomas Rice blocked FDA from taking "any action to remove mifepristone from the market or otherwise cause the drug to become less available."

The suit aimed to eliminate restrictions FDA has applied to mifepristone, but also requested the judge declare FDA's "approval of mifepristone is lawful and valid" and to enjoin FDA "from taking any action to remove mifepristone from the market or reduce its availability."

Supreme Court allows mifepristone to remain on the market for now

In its ruling issued Friday, the Supreme Court said mifepristone could remain on the market with no new restrictions while the case against it plays out — a process that is likely to take months or longer, Reuters  reports.

The Court did not provide a full vote breakdown; however, Justices Clarence Thomas and Samuel Alito voted to allow the restrictions to mifepristone to remain in place, with Alito issuing a four-page dissent.

The case will now return to the 5th U.S. Circuit Court of Appeals, which will hear arguments on May 17. The Supreme Court's stay will remain in place even after the 5th Circuit's ruling.

According to Adam Unikowsky, a partner at  Jenner & Block, Friday's order means it's likely FDA will win its case, as the legal standard for issuing a stay requires the Supreme Court to assess the likelihood of FDA's success on the merits of the case.

Reaction

President Joe Biden praised the Supreme Court's decision, saying the "stakes could not be higher for women across America."

"I will continue to fight politically-driven attacks on women's health," Biden said. "But let's be clear — the American people must continue to use their vote as their voice, and elect a Congress who will pass a law restoring the protections of Roe v. Wade."

In a statement, Vice President Kamala Harris noted the potential risk of FDA's approval of mifepristone being overturned.

"Americans need to look no further than their medicine cabinet to see how many FDA-approved medications are at risk if lower court decisions disregarding the FDA's scientific judgment are allowed to stand," she said.

Joshua Sharfstein, a public health professor at Johns Hopkins University and former FDA official, said the Supreme Court's stay is "the right decision and a huge relief."

"The alternative would have not only undermined access to reproductive health care, it would have thrown into disarray drug regulation in the United States," Sharfstein said.

"As is common practice, the Supreme Court has decided to maintain the status quo that existed prior to our lawsuit while our challenge … moves forward," said Erik Baptist, senior counsel for Alliance Defending Freedom, which represents the anti-abortion groups in the lawsuit. "We look forward to a final outcome in this case that will hold the FDA accountable." (Bernstein, Reuters, 4/24; Axios, 4/24; Sherman, Associated Press, 4/21; Sink/Rozen, Bloomberg, 4/21; Owermohle, STAT, 4/21)

3 consequences of restricting access to medication abortions

Gabriela Marmolejos and Kaci Plattenburg 

While this decision temporarily allows mifepristone to remain on the market, it is still unclear whether this will change in the coming months. Considering the Supreme Court's decision to overturn the 1973  Roe v. Wade decision in the Dobbs v. Jackson Women's Health case last summer, it is possible that the court will eventually decide to revoke FDA's approval of mifepristone or prohibit the delivery of the medication by mail.

Following the  Dobbs v. Jackson decision, we have seen a wave of new abortion restrictions enacted by states across the country. Restrictions include gestational age bans, restricting use of telehealth for abortions, and criminalizing self-managed abortions.

If enacted, additional medication abortion restrictions could negatively impact women's health in three ways:

1.  Women could experience longer, more intense side effects

Since misoprostol alone is safe and effective for terminating a pregnancy in the first trimester, most U.S. abortion providers will likely switch to this protocol if mifepristone becomes unavailable. However, many providers currently prefer the two-medication protocol, largely because misoprostol alone is associated with increased nausea, vomiting and diarrhea, as well as a longer duration of cramping and bleeding.

2.  Women traveling for abortions could delay care

More women may be required to travel for abortions if the courts restrict the mailing of medication abortion. Women who are required to travel for abortions are more likely to delay care and receive abortions at later gestations, which increases various health risks. According to a  study  published in Obstetrics & Gynecology, women who travel farther for abortions are 2.3 times more likely to need an ED visit compared to those with care available locally.

3. More women may be forced to carry unwanted pregnancies to term

There are known risks associated with carrying unwanted pregnancies to term — for both mothers and their families. Typically, women with unwanted pregnancies are less likely to adhere to recommended perinatal practices, such as taking folic acid, attending prenatal care visits, and breastfeeding. This increases risks of pregnancy complications and negative health outcomes among newborns.

Notably, these risks are heightened among women of color who are already  facing high maternal mortality rates  in the United States. Overall, individuals denied abortions are  more likely  to earn low incomes, lack health insurance, and represent Black and Hispanic populations. This evidence suggests new restrictions are likely to worsen health disparities by increasing risks of maternal mortality and deepening financial hardships among people of color.

As the appeals process unfolds in the coming months, health industry leaders should continue to meet long-standing calls to advance women's health equity by revisiting  care delivery protocols and addressing the  root causes  of health inequities to help mitigate these health risks.  

(Phillips, Washington Post, 4/19; Center for Reproductive Rights report, accessed 4/24; American College of Obstetricians and Gynecologists statement, 7/6/2022; Gordon, "Shots," NPR, 4/10; Cartwright et al., Journal of Medical Internet Research, 12/22/2017; Upadhyay et al., Obstetrics & Gynecology, 9/2017; Robbins et al., Journal of Women's Health, 6/29/2021; Office on Women's Health prenatal guidelines, accessed 4/24; Kost/Lindberg, Duke University Press, 1/9/2015)