Updated – Changing abortion pill access according to the US FDA and Supreme Court

After the approval of the medical abortion pill, mifepristone, by the US FDA, states across the USA approach the distribution of the pill differently, some ruling against allowing access to the drug. 

13 June 2024 – The US Supreme Court has rejected the proposed ban on abortion pills across some states in America from anti-abortion activists and some doctors. The rejection represents a victory for the Biden administration, who have been advocating for women's right to access to medicine, especially since the overturning of Roe v Wade in 2022, which triggered some states to restrict the use of abortion medication.

Mifepristone was apporved in 2000 and is used in around 60% of abortions in the USA, representing an essential part of women's healthcare, and more broadly, freedom of choice. 

At the end of June the Supreme Court will be voting on the legality of the strict abortion ban in place in Idaho, where even terminating a pregnancy to protect a pregnant woman facing a medical emergency is prohibited. 

8 September –  Following the 5th Circuit Court decision in New Orleans in August to place a ban on the distribution of the abortion pill based on the request of an anti-abortion group, President Joe Biden's administration has opposed the ruling in the Supreme Court review. Danco Laboratories has also submitted an appeal against the curbing of the application of the pill. The proceedings are due to start in October 2023, with a decision reach by June 2024. 

16 August – A USA appeals court, the New Orleans 5th Circuit Court of Appeal, ordered for a ban to come into action on telemedicine prescriptions and shipments of mifepristone by mail. This comes after reviewing the lower courts appeals for restrictions to be placed on the use of the abortion pill earlier in the year. The ban will be reviewed by the Supreme Court later in the year. 

21 April – The US Supreme Court successfully blocks the new restrictions that were laid down in the previous weeks by judges in lower courts. The Supreme Court Justices were able to grant emergency requests to block injunctions on the sale of mifepristone put in place by a Texas judge. The requests to block the injunctions came from the US Justice Department and Danco Laboratories, the maker of the drug. 

"As a result of the Supreme Court's stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts," President Joe Biden said in a statement issued by the White House.

12 April – The US Justice Department is working to block the Texas judge's injunction to halt sales of mifepristone. The medicine is the most commonly prescribed for the procedure and is used in over half of abortion cases in the US, if prohibited, there would be a significant public health risk. 

The FDA, stuck between a rock and a hard place, could act by simply not acting. There is a 1985 precedent set where the FDA has chosen not to act on the use of unapproved drugs, (which they could forcibly remove from the market) due to priortising risk to human health. By not acting under its enforcement discretion, the FDA would effectively allow continued use of mifepristone. 

10 April – An open letter from the pharmaceutical industry, signed by executives from over 300 biotech and pharma companies, objected to the suspension of sales of the abortion pill in Texas. 

The letter was written by Shehnaaz Suliman, CEO of ReCode Therapeutics, Amanda Banks, co-founder of Blackfynn, and Jeremy Levin, CEO of Ovid Therapeutics. It states the ruling undermines the authority of the FDA to approve drugs in a safe way, and threatens the status quo of the whole industry. 

"If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone," the letter stated.

Among the companies supporting the letter are Pfizer and Biogen.

"This is a nightmare scenario for the industry," asserted Levin. "It's the single worst threat to the industry in over 50 years."

On 7 April 2023, A US district judge in Texas moved to suspend the approval of the medical abortion pill, mifepristone, initially granted by the FDA in 2000. 

GenProBio developed a generic of the drug, which was approved by the FDA in 2019, to make the medication more easily accessible to those who need it.  

The judge submitted a 67 page ruling, off the back of a court case in Texas brought by four anti-abortion activist groups, outling an injunction that would cause the cessation of sales of mifepristone, claiming that the FDA approval overlooked safety concerns about the drug. 

Just minutes after this ruling came into effect a federal judge based in Washington state issued an order to the FDA that would prohibit them from overturning the approval of mifepristone. 

In the US, retail pharmacies will be allowed to sell abortion pills for the first time, after latest approval is granted by the FDA.

The abortion pill mifepristone (under the brand name Mifeprex) was first approved by the US FDA in 2000 for medical termination of pregnancy. In combination with the drug misoprostol, Mifeprex has a range of uses such as miscarriage management and inducing abortion up to 10 weeks. Now, pharmacies can apply for certification to distribute the medication with one of the companies that make it, Danco Laboratories and GenBioPro. Once they have received certification they would be able to dispense the pill to patients who have gained a prescription. 

The medication had been used in accordance with strict risk evaluation and mitigation strategies since 2000, but these were temporarily lifted during the COVID-19 pandemic. Since, the FDA has announced that it would be relaxing some of those reinstated strategies, to make the drug more accessible for patients. Some of these changes included the removal of restrictions on mail order shipping of the pills and the gaining of a prescription via telehealth, the use of which has soared since the pandemic. 

FDA approval comes after Danco Laboratories and GenBioPro submitted supplemental applications for the drug to be distributed in pharmacies in the USA.

"Under the mifepristone REMS Program, as modified, Mifeprex and its approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber," the agency posted on its website.

The move is supported by abortion rights activists, who iterate that the abortion pill has been proven to be safe and effective for use, and in many countries, such as India and Mexico, can be bought for use without the need for a prescription. 

"Today's news is a step in the right direction for health equity," Planned Parenthood President Alexis McGill Johnson stated, "Being able to access your prescribed medication abortion through the mail or to pick it up in person from a pharmacy like any other prescription is a game changer for people trying to access basic health care." 

However, in the US, the new regulations don’t necessarily translate to equal access to healthcare with the abortion bans put in place in several states still giving rise to the prohibition of abortion pills, meaning women in need may have to travel across state boundaries to obtain the medication. 

Sources:

[1] Judges issue conflicting abortion-pill injunctions | Reuters

[2] Pfizer, Biogen among hundreds of US drugmakers calling for abortion pill ruling reversal | Reuters

[3] Half of Republicans say politics drove US abortion pill court ruling -Reuters/Ipsos | Reuters

[4] Abortion-pill ruling threatens FDA’s authority, say drug firms (nature.com)

[5] US Supreme Court preserves access to abortion pill mifepristone | Reuters