The agency’s stance is a rebuke of a method of prescription, advance provision, that has developed as a means of countering state abortion restrictions since Roe vs. Wade fell this summer. The FDA 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 activists. of the right to abortion.
The FDA spokesperson told POLITICO that if mifepristone, which stops the flow of hormones supporting a fetus in the womb, was prescribed before a patient is pregnant, providers would not be able to properly supervise care to ensure safety and effectiveness. Abortion drugs are more tightly regulated by the FDA than other drugs, which limits how the diet can be prescribed.
Some telemedicine providers, including Choice, as well as in-person providers, began offering the pills before pregnancy to expand access to abortion after the June Supreme Court ruling that gave states the right to prohibit the procedure.
Netherlands-based Aid Access has been doing this since last fall, when Texas’ six-week abortion ban went into effect.
Proponents of early provision say it allows patients who fear losing access to abortion due to the court ruling to be prepared in case they need an abortion at a later date, and that it is safe and effective.
Choice CEO Cindy Adam pushed back against the FDA in a statement to POLITICO, saying restrictions on medical abortion are unnecessary and the diet is safe. Choice offers “continuous and supportive” care throughout the process, she said.
Aid Access did not respond to a request for comment.
Doctors sometimes provide other drugs to patients before the patient has a condition that the drug is supposed to treat, if a patient is at risk. For example, some doctors will give antibiotics to patients who frequently get bronchitis or urinary tract infections, or blood thinners to people who have a history of blood clots.
But the FDA is concerned that if patients were to take mifepristone weeks or months after getting a prescription filled, a healthcare professional might not be able to assess whether a pregnancy is intrauterine or ectopic. or to date pregnancies correctly. The drug is only approved up to 70 days of gestation for abortions.
Adam said Choice screens patients for risk factors for ectopic pregnancy and other contraindications and patients are told they should seek further care if they become pregnant. “Science has consistently shown that when people have accurate information and access to abortion pills, they can safely end a pregnancy at home,” she said. “Providing abortion care through an advance benefit should be no different.”
In December, the FDA allowed doctors to prescribe mifepristone — one of two drugs patients take to induce an abortion — through virtual appointments and to ship the drugs by mail.
The American College of Obstetricians and Gynecologists has asked the FDA to remove all restrictions on mifepristone.
“I’ve talked to providers who have done this for years where the patient was going somewhere where they were going to have difficulty accessing care,” said Daniel Grossman, who leads the Advancing New Standards in Reproductive Health research group. . “It’s also not that different from what we were doing with emergency contraception before it was available over the counter.”
The FDA spokesperson declined to say whether the agency plans to change the restrictions.
The spokesperson also did not say whether the agency took enforcement action for misprescribing mifepristone, but the FDA can enforce its regulations by fining violators, seizing drugs, or imposing a penalty. injunction.