The tug of war on abortion pills

The past two weeks have been a tumultuous time for the abortion pill. Here’s a timeline of recent events:

Friday, April 7: A U.S. District judge in Texas rules to place a national ban on access to the FDA-approved mifepristone abortion pill on the basis of it being unsafe
Friday, April 7: A Washington state judge bans U.S. authorities from changing abortion pill access in 17 states
Wednesday, April 12: A federal appeals court allows partial access to mifepristone, but limits access to seven weeks of pregnancy instead of the previous ten and prohibits mail delivery
Thursday, April 13: Biden files an emergency request for the Supreme Court to overturn the federal ruling
Wednesday, April 19: The maker of the generic abortion pill sues the FDA over damages from restricted access to this medication
Friday, April 21: The Supreme Court temporarily preserves access to the pill, preventing states from acting under the federal judge's ruling

On Friday evening, Matthew Kacsmaryk, a U.S. District judge in Texas, ruled to suspend the FDA’s approval of one of the two drugs used to induce abortions — mifepristone. The ruling would not take effect for a week, giving the FDA time to appeal the decision. Kacsmaryk’s ruling challenged the initial approval of the pill from the early 2000s and the more recent decision that allows the pill to be prescribed via telehealth and available in pharmacies. His ruling was based on concerns about the possible negative reactions; however, there is no evidence to question the pill’s safety. The judge, who worked for a conservative Christian legal advocacy group and has no scientific expertise, is also a known supporter of the anti-abortion movement.

This is the first time a judge has questioned the FDA’s approval and removed access to a drug available on the market. Not only would this ruling affect thousands of women who rely on medical abortions, but it would set a precedent to allow the removal of any drug and completely disband the system that is the FDA.

That same evening, a Washington state federal judge, together with over a dozen democratic states, issued an order to block the FDA from changing access to the pill. Not only did the judge’s ruling maintain access to the pill in Democratic states, but the contrasting ruling increased the likelihood of the case going to the Supreme Court.

That Friday night, Biden promised to “fight [the Texas] ruling” and the Justice Department stated that it “strongly disagrees” with the Texas ruling and “is committed to protecting American’s access to legal reproductive care." Despite these promises, anti-abortion groups took the Texas ruling as a victory.

The following Monday, the Biden administration filed an emergency request for the appeals court to block the ruling, saying that the Texas judge made a series of errors, including filing the lawsuit.

On Wednesday, the federal appeals court ruled on partial access to the mifepristone pill while the case is being appealed. They imposed two limitations: changing the approved time from 10 weeks to seven weeks of pregnancy and ruling that the pill could no longer be sent by mail. The Biden administration then appealed this decision to the Supreme Court in an effort to maintain existing access. At the same time, Massachusetts, California, and Washington announced they were stockpiling abortion pills to ensure a supply even if mifepristone would be pulled from the market. Even if the Texas ruling suspended mifepristone, it would not affect the use of pills already in states’ possessions.

A week later, GenBioPro, the producer of the generic version of mifepristone, sued the FDA in an effort to maintain federal access to the pill. The lawsuit is based on the idea that revoking the approval of generic mifepristone would cause “catastrophic harm” to the company and doctors and patients who rely on it. The generic version, which was approved in 2019, accounts for two-thirds of mifepristone sold nationally and is being targeted in the Texas ruling. The company also opposed the Texas decision, saying it would disincentive companies from developing new mediation if they would lose protections provided by the FDA.

Last Saturday, two weeks after the initial Texas ruling, the Supreme Court ordered to maintain access to mifepristone. This was a temporary decision, but it sent a strong message: ruling against the FDA and removing an approved drug from access is too far. After this ruling, the case returns to the court that made the Wednesday decision to allow partial access to the pill. The court will hear the argument on May 17. Regardless of how that court rules, the losing side will likely appeal to the Supreme Court, which will have the choice to make a ruling.

While the future of mifepristone remains unclear, some scholars believe the Friday ruling is a sign the Supreme Court is sticking to its promise of staying out of abortion laws. Also, mifepristone is the first of two pills used to administer abortions, and doctors are preparing for a future where only the second, misoprostol, is used. To learn more about how abortion pills work, read Anna Capella’s article in SciTech.