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FDA to permit some retail pharmacies to dispense abortion pills

The Food and Drug Administration took steps on Tuesday to ease access to medication abortion in states where it is legal, allowing retail pharmacies to dispense the pills, which were previously available only at clinics, directly from doctors or by mail.

The regulatory change, which was released with little fanfare or explanation Tuesday night, appeared to reflect the Biden administration’s desire to deliver on its vow to keep abortion accessible after the Supreme Court’s June decision overturning the constitutional right to abortion.

The FDA had announced a year ago that it would update protocols for prescribing the abortion pill mifepristone — the first pill used in the two-drug regimen for medication abortions. On Tuesday, the agency completed that update by cementing a pandemic-era change that expanded telehealth access to the procedure. The agency also indicated it would allow certain pharmacies to dispense abortion pills directly, rather than by requiring patients to pick them up from a health care facility, or wait for them to come in the mail from a handful of mail-order pharmacies.

Under the new rules, patients will still need a prescription from a certified health care provider, but any pharmacy that agrees to accept those prescriptions and abide by other criteria can dispense the pills in its 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 an update to a section of its website.

Medication abortions have become increasingly common since the FDA approved mifepristone more than two decades ago and now account for more than half of pregnancy terminations in the United States, according to the Guttmacher Institute, which supports abortion rights. As a result, the pills have become the latest battleground over abortion, as conservative states take steps to make it more difficult to access the medication.

The American College of Obstetricians and Gynecologists — which has long advocated for retail pharmacies to dispense the drug — called it an “important step forward in securing access to medication abortion.

“This change will empower patients who choose medication abortion to have the option of going to a pharmacy for immediate care rather than waiting for a mail order, if that is right for them,” Iffath Abbasi Hoskins, ACOG’s president, said in a statement, adding the group will continue to advocate to further remove other rules around accessing the medication.

Some abortion rights advocates said the impact of the change remains unclear, however, including how many brick-and-mortar stores will choose to take advantage of it.

“A real question is, will retail pharmacies seek certification?” said Rachel Rebouche, dean of Temple University’s Beasley School of Law, referring to major chains like CVS and Walgreens. If they do, she said, “It could change the conversation about abortion, opening up avenues for people in rural parts of a state.”

Antiabortion opponents who have sought to limit medication abortion, decried the changes.

“This is an extremely negligent act on the part of the FDA, which has just increased the number of places where you can acquire the pills that can harm women, and certainly harm the pre-born,” said Kristi Hamrick, chief media and policy strategist for Students for Life of America, a national antiabortion group.

Late last month, the group filed a petition asking the FDA to increase requirements around abortion pills, such as by mandating the medication be administered by or under the supervision of a physician who is physically present with the patient.

The changes laid out by the FDA are likely to intensify the debate over abortion access, which has become increasingly polarized since the Court’s decision in Dobbs v. Jackson Women’s Health Organization.

Antiabortion advocates have sought to stem the flow of pills in states with abortion bans and find ways of cracking down on those who break the law. More than a dozen states restrict abortion in many instances since the high court overturned Roe v. Wade.

The intensifying fights may influence how many pharmacies elect to participate in the program. To become certified to dispense mifepristone, pharmacies will need to demonstrate, among other things, that they can ship the drug using a service that provides tracking information.

“Certification is a hurdle,” said Ameet Sarpatwari, an assistant professor of medicine at Harvard Medical School. “I am of the opinion that those safeguards are not needed considering the safety protocol of the drug.”

Amy Thibault, a spokeswoman for CVS said Tuesday that the company is “reviewing the FDA’s updated Risk Evaluation and Mitigation Strategy (REMS) drug safety program certification requirements for mifepristone to determine the requirements to dispense in states that do not restrict the dispensing of medications prescribed for elective termination of pregnancy.”

Fraser Engerman, a spokesman for Walgreen Co., said that company is also reviewing the changes before it makes any decisions.

Mifepristone, also known as RU-486 and sold under the brand name Mifeprex, is used in combination with another drug, misoprostol, to terminate pregnancies up to 10 weeks gestation. Mifepristone prevents a pregnancy from proceeding by blocking the hormone progesterone. Misoprostol subsequently causes the uterus to contract and expel tissue, much like a miscarriage.

The FDA first approved the drug in 2000. Common side effects include cramping and bleeding, with more occasional reports of heavy bleeding that needs to be stopped through surgery. But adverse events are rare. As of June 2021, 26 deaths had been reported, including two linked to ectopic pregnancies, according to data collected by the FDA. The agency determined those deaths cannot be attributed to mifepristone either because of the patients’ concurrent use of other drugs, other medical or surgical treatments, or information gaps about the their health status.

In a statement, GenBioPro, referred to the FDA move as “a step in the right direction that is especially needed to increase access to abortion care.”

Last year, GenBioPro had dropped a lawsuit challenging a Mississippi law that restricted telehealth abortion services, arguing the FDA’s authorization should hold sway. That question could 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’s ruling, arguing over the summer that Democrats should push boundaries to protect access to the procedure. In November, nine Democratic senators had urged the FDA to take steps to make it easier to get the abortion medication.

Antiabortion groups have also sought to find ways to limit access to the drug, including by suing the FDA in November in an attempt to reverse the agency’s approval of mifepristone. Conservative group Alliance Defending Freedom filed the suit on behalf of four antiabortion medical organizations and doctors, arguing the agency lacked the authority to approve the drug, didn’t adequately study it and the medication is unsafe.

Top medical groups — like the American Medical Association and American College of Obstetricians and Gynecologists — consider the drug to be safe and effective.

This post appeared first on The Washington Post

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