The Food and Drug Administration announced a year ago that it would update prescribing protocols for the abortion pill Mifepristone – the first pill to be used in a two-drug regimen for medical abortion. On Tuesday, the agency completed that update by anchoring a pandemic-era change that expanded access to telehealth for the procedure. The agency also indicated that it would allow some pharmacies to distribute abortion pills directly, rather than requiring patients to pick them up from a healthcare facility, or wait for them to arrive in the mail from a few mail-order pharmacies.
Under the new rules, patients will still need a prescription from an approved healthcare provider, but any pharmacy that agrees to accept those prescriptions and adhere to other standards can dispense the pills in their stores and by mail.
GenBioPro, the company that makes the generic version of the abortion Pill, announced the change in an email and the FDA described the changes in a dossier Update to section of their website.
Medical abortion has become increasingly common since the FDA approved mifepristone more than two decades ago, and it now accounts for more than half of all pregnancy terminations in the United States, according to the Guttmacher Institute, which supports abortion rights. As a result, the pill has become the latest battleground over abortion, as conservative countries take steps to make it more difficult to obtain the drug.
The American College of Obstetricians and Gynecologists — which has long advocated for retail pharmacies to distribute the drug — described it as “an important step forward in securing access to medical abortion.”
“This change will enable patients who choose medical abortion to have the option of going to a pharmacy for immediate care instead of waiting for a mail order, if it is convenient for them,” ACOG President Evath Abbasi-Hoskins said in a statement. The group’s addition will continue to advocate for the removal of more and more rules around access to medication.
Some abortion rights advocates said the impact of the change remains unclear, including how many traditional stores will choose to take advantage of it.
“The real question is, will retail pharmacies pursue certification?” said Rachel Rebusch, dean of Temple University’s Paisley School of Law, referring to major chains like CVS and Walgreens. If they do, she said, “it could change the conversation about abortion, and open avenues for people in rural areas of the state.”
Anti-abortion opponents who sought to limit medical abortion, decried the changes.
“This is a very negligent act on the part of the Food and Drug Administration, which has just increased the number of places you can get pills that can harm a woman, and certainly harm a baby,” said Kristi Hamrick, chief of media and policy. A strategist for Students for Life in America, a national anti-abortion group.
late last month, The group filed a petition Asking the US Food and Drug Administration to increase requirements regarding the abortion pill, such as requiring a doctor to administer the drug on or under his supervision.
The changes introduced by the Food and Drug Administration are likely to intensify the debate about abortion access, which has become increasingly polarized since the court’s decision in Dobbs v. Jackson Women’s Health.
Anti-abortion advocates have sought to stem the flow of grain in states that ban abortion and find ways to crack down on those who break the law. More than a dozen states have restricted abortion in many cases since the Supreme Court struck down Roe v. Wade.
Intense fights may affect the number of pharmacies that choose to participate in the program. In order to become approved to dispense mifepristone, pharmacies will need to prove, among other things, that they can ship the drug using a service that provides tracking information.
“Certification is a hurdle,” said Amit Sarpatwari, MD, assistant professor of medicine at Harvard Medical School. “I am of the opinion that these assurances are not necessary given the drug safety protocol.”
Amy Thibault, a CVS spokeswoman, said Tuesday that the company is “reviewing FDA’s updated risk assessment and mitigation strategy of the Drug Safety Program’s certification requirements for mifepristone to determine dispensing requirements in states that do not restrict prescription drug dispensing for elective termination of pregnancy.”
Fraser Engerman, a Walgreen Co. spokesperson, said the company is also reviewing changes before it makes any decisions.
Mifepristone, also known as RU-486 and sold under the brand name Mifeprex, is used together with another drug, misoprostol, to terminate pregnancy up to 10 weeks gestation. Mifepristone prevents a pregnancy from continuing by blocking the hormone progesterone. The misoprostol then causes the uterus to contract and expel the tissue, much like a miscarriage.
FDA first agreed medication in 2000. Common side effects include cramping and bleeding, with more occasional reports of severe bleeding that needed to be stopped through surgery. However, adverse events are rare. As of June 2021, there have been 26 reported deaths, including two related to ectopic pregnancies, According to data collected by the Food and Drug Administration. an agency determined Those deaths could not be attributed to mifepristone either because of the patients’ concurrent use of other drugs, or other medical or surgical treatments, or because of gaps in information about their health status.
In a statement, GenBioPro referred to the FDA’s move as “a step in the right direction that is particularly needed to increase access to abortion care.”
Last year, GenBioPro dropped a lawsuit challenging a Mississippi law restricting telehealth abortion Services, arguing that the FDA’s authorization should have the effect. This question may be addressed in future litigation.
Some Democrats and advocates have expressed frustration with the White House and party leaders over their response to the Supreme Court ruling, saying over the summer that Democrats Limits must be pushed To protect access to the procedure. In November, Nine Democratic senators The Food and Drug Administration urged that steps be taken to make abortion medicine easier to obtain.
Anti-abortion groups have also sought ways to limit access to the drug, including by means of He sued the Food and Drug Administration in November in an effort to reverse the agency’s approval of mifepristone. The group Alliance Defending Freedom filed the lawsuit on behalf of four medical organizations and anti-abortion physicians, arguing that the agency lacked the authority to approve the drug, did not adequately study it and that the drug was unsafe.
Top medical groups — such as the American Medical Association and the American College of Obstetricians and Gynecologists — look at the drug to Be safe and effective.