Retail pharmacies can now offer abortion pill, FDA says


Contents of the rule: Once the policy is implemented, chain stores and independent pharmacies will be able to store and dispense medicines to pregnant women by prescription. However, it is unclear how many pharmacies would agree to do so, given the special certification process required. Until now, depending on state law, pregnant women could pick up their pills directly from their doctor or have them mailed to them via telemedicine.

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

“FDA has determined that removing the face-to-face dispensing requirement and adding a pharmacy certification requirement is necessary to minimize the compliance burden on the healthcare delivery system. [agency’s Risk Evaluation and Mitigation Strategy]while ensuring that the benefits of mifepristone over medical abortion outweigh the risks,” he said.

However, many states have enacted laws banning abortion in most circumstances or requiring patients to obtain the pill directly from a prescribing physician, so the policy is “equal access for all.” We don’t offer it,” he added.

Important reasons: Abortion drugs recently became the most common method of abortion in the United States and have been the focus of the most intense legal, political and regulatory battles since the Supreme Court overturned it. Law vs Wade June 2022.

Telemedicine and pill mailings allow patients to circumvent state bans, and anti-abortion groups are seeking new ways to impose restrictions on them. Meanwhile, the Biden administration defends abortion rights There has been pressure from groups and progressive lawmakers to do more to protect access after abortion.egg times.

The new rules will only improve access to pills in states that already allow their use, but many patients in states that are banned do so by picking up drugs from pharmacies across state lines. available.

And while they were already able to get some medicine, many people in more progressive states would like to see someone without a stable home address, a parent or partner to see the pills delivered. Those without access to email and the Internet are expected to benefit from new pharmacy options.

How I got here: Anti-abortion and pro-abortion groups have fought over FDA regulation of abortion drugs since they were first approved more than 20 years ago. In medical abortion, mifepristone is taken with misoprostol, which is less restrictive because misoprostol is commonly used for other purposes, such as inducing labor and treating stomach ulcers. New FDA regulations lift some of the more tightly regulated restrictions on mifepristone.

REMS is a program created by the agency to manage Mifeprex and dozens of drugs with significant safety risks that require specific monitoring or control techniques. Proponents of increasing access to medical abortion argue that the drugs used in the process are safe and should not be subject to REMS.

Until 2021, mifepristone could only be dispensed by a physician. The Biden administration has since responded to lawsuits by the ACLU and other groups to allow telemedicine prescriptions and mailings only during the Covid-19 pandemic. ‘ Safety and efficacy.

GenBioPro and Danco Laboratories, which manufacture tablets under the brand names Mifeprex, will jointly submit a response to the FDA in June 2022 asking for further changes to the REMS for this drug, especially the approval process for pharmacies that dispense the drug. I asked.

Currently, mifepristone distributors must be certified by the drug manufacturer, and prescribing physicians must know how the drug induces abortion and how to advise patients about its use. Patients must also sign a disclosure forum acknowledging that they are taking medication to terminate the pregnancy.

Currently, pharmacies accredited under the REMS can dispense mifepristone directly to patients with a prescription from an accredited prescriber.

“At a time when people across the country are struggling to access abortion care services, this change is critical to expanding access to medical abortion services and encouraging health care providers to provide safe and effective services for their patients. We are providing additional ways to provide abortion options in the first trimester of pregnancy,” Danco Laboratories, which makes the branded drug Mifeprex, said in a statement.



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