The agency’s position is a rebuke to the prescription-advance method that has grown as a way to counter abortion restrictions in states since Roe v. Wade dropped this summer. The FDA’s position also puts the Biden administration — the president has publicly pledged to do everything in his power to preserve access to abortion — at odds with some abortion providers and abortion rights activists.
An FDA official told POLITICO that if mifepristone, which stops the flow of hormones that support the fetus in the uterus, is given to a patient before she becomes pregnant, providers will not be able to properly monitor the treatment to ensure safety and effectiveness. Abortion drugs are regulated by the FDA more tightly than other drugs, which limits how the regimen can be prescribed.
Some telemedicine providers, including Choixas well as private providers, began offering the birth control pill as a way to expand access to abortion after a Supreme Court ruling in June that gave states the right to ban the procedure.
The Netherlands Aid Access does since last autumnwhen the six-week abortion ban went into effect in Texas.
Proponents of preemption say it allows patients who fear losing access to an abortion because of a court order to be prepared in case they need an abortion at a later date, and that it is safe and effective.
Choix CEO Cindy Adam spoke out against the FDA in a statement to POLITICO, saying restrictions on medical abortion are unnecessary and that the regimen is safe. Choix offers “ongoing, supportive” care throughout the process, she said.
Aid Access did not respond to a request for comment.
Doctors sometimes give patients other drugs before the patient develops the disease the drug is intended to treat if the patient is at risk. For example, some doctors will give antibiotics to patients with frequent bronchitis or urinary tract infections, or blood thinners to people with a history of blood clots.
But the FDA is concerned that if patients take mifepristone weeks or months after getting a prescription, a healthcare professional won’t be able to assess whether the pregnancy is intrauterine or ectopic, or correctly date the pregnancy. The drug is approved for abortions only after 70 days of pregnancy.
Adam said Choix screens patients for risk factors for ectopic pregnancy and other contraindications and that patients are told to seek more help if they become pregnant. “Science consistently shows that when people have accurate information and access to the contraceptive pill, they can safely terminate pregnancies in their own homes,” she said. “Providing abortion care through advance provision should be no different.”
In December, the FDA allowed doctors to prescribe mifepristone — one of two drugs that patients take to induce an abortion — through a virtual appointment and send the medication by mail.
The American College of Obstetricians and Gynecologists urged the FDA to remove all restrictions on mifepristone.
“I’ve talked to providers who have done this for years when a patient is going somewhere where it’s going to be difficult for them to access care,” said Daniel Grossman, who leads the research group Advancing New Standards in Reproductive Health. “It’s also no different than what we did with emergency contraception before it became available over the counter.”
An FDA spokesman declined to comment on whether the agency is considering changing the restrictions.
The spokesman also did not say whether the agency had taken any enforcement action for misprescribing mifepristone, but the FDA can enforce its rules by fining violators, confiscating drugs or imposing a ban.