The Biden administration says it’s taking steps to increase access to medication abortion in response to the Supreme Court decision to reverse Roe v. Wade, but some of the administration’s own policies stand in the way of people trying to get the drug.
Mifepristone, the drug known as the abortion pill, has been approved in the US for more than 20 years and has been shown to be safer than commonly used drugs like Tylenol. But federal regulations strictly limit the circumstances under which patients can get it. While the administration last year loosened some rules on prescribers, it added new hurdles for pharmacies to dispense abortion pills. Several states have regulations on top of that, limiting who can prescribe it or requiring people to attend in-person doctor’s appointments to get the pill.
The White House quickly pointed to the abortion pill as an answer to the post-Roe world in which
Health and Human Services Secretary
“Medication abortion -- those treatments that FDA has signed off on as safe and effective -- are available to be prescribed,” Becerra said at a news conference this week. “Under what conditions? Stay tuned.”
The FDA has been under pressure for years from medical and advocacy groups to loosen restrictions on the abortion pill. Leading medical bodies have called the rules unnecessary. In response to a lawsuit, the agency amended its policies and in December permanently allowed the abortion pill to be
It also added a new restriction: any pharmacy that wanted to dispense the abortion pill had to be certified. That created another bureaucratic hurdle that continues to limit the pill’s reach.
“These pills have been around for decades now but they’ve been overregulated,” said Elisa Wells, cofounder of Plan C, an organization that helps women access abortion pills online. She said the FDA’s restrictions should have been lifted “decades ago, so these safe and effective pills could be made available through pharmacies, just like any other pills.”
Despite its safety record, mifepristone is only available to patients under a risk evaluation and mitigation strategy, or REMS, that requires education and monitoring for doctors and patients. Such policies are normally reserved for drugs with exceptionally rare and dangerous side effects.
The American College of Obstetricians and Gynecologists opposes the restrictions on mifepristone, saying that “decades of evidence and the consensus of the medical community underscore” the drug’s safety, according to the professional group’s website. The American Medical Association has also repeatedly
Late last year, the FDA said that patients need only a virtual doctor visit to get the drug, permanently lifting a requirement for in-person consults that had been relaxed during the pandemic. But with that, the agency added a new requirement for the manufacturers --
Danco said in an email Tuesday that it has submitted a tentative pharmacy certification plan to the FDA, which must approve the plan before it takes effect. The company added the FDA’s timeline is “uncertain,” and that it expects “there will be several discussions between us and the FDA before finalization.”
GenBioPro didn’t respond to requests for comment.
The FDA didn’t address questions this week about when pharmacies would be certified to dispense abortion pills. The FDA said the certification rules for pharmacies “will ensure that pharmacies are aware of and agree to follow applicable REMS requirements, and ensure that mifepristone is only dispensed with a written prescription from certified prescribers,” in an email response to questions from Bloomberg News in May.
It’s unclear how state abortion bans now taking effect following the Supreme Court’s reversal of federal abortion rights will affect the availability of these pills. The three liberal justices noted the uncertainty in their dissenting opinion:
“Can a State interfere with the mailing of drugs used for medication abortions? The Constitution protects travel and speech and interstate commerce, so today’s ruling will give rise to a host of new constitutional questions,” they wrote.
Mississippi has put restrictions on prescribing mifepristone that are stricter than the federal rules, including requiring that a licensed physician prescribe it in person. GenBioPro has challenged the state’s policy in a lawsuit. The company argues that the FDA’s regulations for dispensing and prescribing the abortion pill preempt state rules. Mississippi has moved to dismiss the lawsuit.
Becerra didn’t respond to questions Tuesday on whether the Biden administration plans to support GenBioPro’s challenge. Constitutional and FDA policy attorneys have said that the company’s argument could serve as a basis for future lawsuits against state mifepristone restrictions.
Some of the largest US pharmacy chains said it’s too early to say whether they plan to dispense the medication. A spokesperson for
Representatives for large US pharmacy operators -- including
No major mail-order pharmacies or pharmacy benefit plans surveyed by
(Updates with Mercer comments in the last paragraph)
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