New FDA proposed rule would expand access to abortion pills

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janvier 4, 2023

The Food and Drug Administration on Tuesday proposed a rule allowing brick-and-mortar pharmacies to dispense the abortion pill mifepristone — expanding access to the drug amid a wave of state efforts last year to impose restrictions.

Pharmacies in more than a dozen states that have near-total abortion bans would not be able to participate and those in states without bans would have to go through a certification process to qualify.

The Biden administration took a major step to open up access in 2021, making permanent pandemic-era rules allowing people to access the pill within the first 10 weeks of pregnancy via telemedicine and mail delivery. But the FDA’s proposed rule opens new legal and regulatory fronts in the ongoing battle over abortion following the fall of Roe v. Wade, and is likely to draw lawsuits from anti-abortion groups and state officials.

What’s in the rule: The policy, once implemented, will allow chain and independent pharmacies to stock and dispense the drug to pregnant people with a prescription. It’s unclear, however, how many pharmacies will agree to do so, considering it requires a special certification process. Until now, pregnant people could either receive the pill directly from their doctor or have it prescribed via telemedicine and sent by mail, depending on their state’s laws.

CEO Evan Masingill of GenBioPro, the generic maker of the medication, called the FDA’s move “a step in the right direction that is especially needed to increase access to abortion care.”

“The FDA determined that removal of the in-person dispensing requirement and the addition of the requirement for certification for pharmacies were necessary to minimize the burden on the health care delivery system of complying with the [agency’s Risk Evaluation and Mitigation Strategy], while still ensuring that the benefits of mifepristone for medical abortion outweigh the risks,” he said.

He added, however, that the policy “will not provide equal access to all people” because many states have laws in place either banning abortion in most circumstances or mandating that patients only get the pills directly from their prescribing doctors.

Why it matters: The abortion pill recently became the most common method of terminating a pregnancy in the United States, and has been the focus of some of the most heated legal, political and regulatory fights since the Supreme Court overturned Roe v. Wade in June 2022.

Telemedicine and mail delivery of the pills has allowed patients to circumvent state bans, and anti-abortion groups are exploring new ways to impose restrictions on them. The Biden administration, meanwhile, has been under pressure from pro-abortion rights groups and progressive lawmakers to do more to protect access in the post-Roe era.

The new rule will improve access to the pills only in states that already allow their use, though many patients in states with bans could take advantage of it by crossing a state line and picking the drugs up from a pharmacy.

And while they had some access to the drugs already, many people in more progressive states are expected to benefit from the new pharmacy option, including those without a stable home address, those who do not want a parent or partner to see the pills delivered by mail and those without internet access.

How we got here: Anti-abortion and pro-abortion rights groups have fought over the FDA regulations around abortion pills since they were first approved more than 20 years ago. In medication abortion, mifepristone is taken with misoprostol, though the latter drug is subject to fewer restrictions because it’s commonly used for other purposes, like inducing labor and treating stomach ulcers. The new FDA rule lifts some restrictions on mifepristone, which was more strictly regulated.

REMS is the program the agency created to manage Mifeprex and a few dozen drugs with serious safety risks, requiring specific monitoring or management techniques. Proponents of increased access to medication abortion have argued the drugs used in the process are safe and shouldn’t be subject to a REMS.

Until 2021, mifepristone could only be dispensed in person by a physician. Then the Biden administration, in response to a lawsuit by the ACLU and other groups, moved to allow telemedicine prescription and mail delivery just for the duration of the Covid-19 pandemic — rules that the agency later made permanent, citing new data about the pills’ safety and effectiveness.

GenBioPro and Danco Laboratories, which makes the pill under the brand name Mifeprex, submitted a joint response to the FDA in June 2022 requesting further changes to the drug’s REMS — specifically, the certification process for pharmacies dispensing the drugs.

Currently, mifepristone distributors must be certified by the drug’s manufacturers, and prescribing doctors must demonstrate they understand how the drug induces abortions and how to advise patients to use it. Patients also must sign a disclosure forum acknowledging they are taking the medication to end a pregnancy.

Now, pharmacies that become certified under the REMS may directly dispense mifepristone to patients with a prescription from a certified prescriber.

“At a time when people across the country are struggling to obtain abortion care services, this modification is critically important to expanding access to medication abortion services and will provide healthcare providers with an additional method for providing their patients with a safe and effective option for ending early pregnancy,” Danco Laboratories, which makes the branded drug Mifeprex, said in a statement.

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