What’s in the rules: After the policy comes into force, chain and independent pharmacies will be allowed to stock and dispense the drug to pregnant people with a prescription. However, it is unclear how many pharmacies will agree to do so, given that it requires a special certification process. Until now, pregnant people could either get the pill directly from their doctor or have it prescribed via telemedicine and sent by mail, depending on their state’s laws.
Evan Massingill, CEO of GenBioPro, the drug’s generic maker, 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 removing the in-person dispensing requirement and adding a certification requirement for pharmacies was necessary to reduce the burden on the health care delivery system. [agency’s Risk Evaluation and Mitigation Strategy]while still ensuring that the benefits of mifepristone for medical abortion outweigh the risks,” he said.
However, he added that the policy “will not provide equal access to all people” because many states have laws either banning abortion under most circumstances or mandating that patients receive the pills directly from their prescribing doctors. Huh.
why it matters: The abortion pill has recently become the most common way to end a pregnancy in the United States, and has been the center of some of the most heated legal, political, and regulatory fights since the Supreme Court overturned it. Roe v. Wade In June 2022.
Telemedicine and mail delivery of pills have allowed patients to circumvent state restrictions, and anti-abortion groups are looking for new ways to ban them. Meanwhile, the Biden administration has been under pressure from pro-abortion groups and progressive lawmakers to do more to protect post-abortion access.Roe deer Era.
The new rule will only improve access to the pills in states that already allow their use, although many patients in states with restrictions can take advantage of it by crossing state borders and picking up drugs at a pharmacy.
And while they already had some access to drugs, many people in more progressive states are expected to benefit from the new pharmacy option, including those who don’t have a stable home address, who don’t want to be prescribed drugs by a parent or partner. See tablets delivered by mail and those that do not have internet.
How we got here: Anti-abortion and pro-abortion rights groups have battled over FDA regulations surrounding abortion pills since they were first approved more than 20 years ago. In medication abortion, mifepristone is taken with misoprostol, although the latter drug is subject to fewer restrictions because it is commonly used for other purposes, such as inducing labor and treating stomach ulcers. The new FDA rule removes some restrictions on mifepristone, which had been more strictly regulated.
REMS is the program the agency created to manage Mifeprex and a few dozen drugs with serious safety risks that require specific monitoring or management techniques. Supporters of increased access to medication abortion have argued that the drugs used in the procedure are safe and should not be subject to REMS.
By 2021, mifepristone could only be given in person by a physician. Then the Biden administration, in response to a lawsuit by the ACLU and other groups, moved to allow telemedicine prescriptions and mail delivery only for the duration of the COVID-19 pandemic — rules the agency later changed based on new data about the pills. Citing made permanent. ‘ Safety and effectiveness.
GenBioPro and Danco Laboratories, which manufacture 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, to the pharmacies that dispense the drug. Certification process for
Currently, mifepristone distributors must be certified by the drug’s manufacturers, and doctors must demonstrate that they understand how the drug induces abortion and how to advise patients on its use. Patients must sign a disclosure form acknowledging that they are taking the drug to terminate a pregnancy.
Now, pharmacies that become certified under REMS can dispense mifepristone directly 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 amendment is critically important to increase access to medication abortion services and provide healthcare providers with a more effective way to terminate their patients.” will provide an additional way to provide a safe and effective alternative to early pregnancy,” Danko Laboratories, which manufactures the branded drug Mifeprex, said in a statement.
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