For the first time, retail pharmacies are going to be allowed to offer abortion pills in the United States.
The news comes following a regulatory change made Tuesday by the Food and Drug Administration, which could significantly expand access to abortion through medication.
Until now, the abortion pill mifepristone could only be dispensed by a few mail-order pharmacies or by specially certified doctors or clinics. During the COVID-19 pandemic, the FDA temporarily suspended the in-person dispensing requirement. The regulatory change makes the temporary suspension permanent, and adds a requirement that pharmacies dispensing the pills become certified.
Under the new FDA rules, patients will still need a prescription from a certified health care provider, but any pharmacy can dispense the pills in retail locations and by mail order.
The change comes as abortion pills are becoming even more sought after in the aftermath of last year's Supreme Court decision overturning the federal right to abortion.
"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 markets the drug under the brand name Mifeprex, said in a statement.
The American College of Obstetricians and Gynecologists called the update an "important step forward" at the end of a "crushing year for abortion care."
"There is no clinical evidence that in-person dispensing improves the safety of this medication or patient outcomes; instead, this requirement unnecessarily restricted patient access to a safe and effective medication," ACOG President Iffath Abbasi Hoskins said in a statement. "ACOG has long advocated that mifepristone be made available in retail pharmacies, just like other prescription drugs, to allow more patients access to abortion care without clinically unnecessary hurdles."
Hoskins added that while the update will not solve access issues for every person seeking abortion care, it will allow more patients additional options to secure the "vital drug."
GenBioPro, the generic maker of the medication, echoed that statement while pointing out that the policy "will not provide equal access to all people," because several states have total abortion bans, some targeting mifepristone. Still, it suggested that women in those states could potentially travel to other states to obtain the drug.
The anti-abortion group SBA Pro-Life America called the move "reckless" and referred to mifepristone as a "dangerous DIY abortion drug."
"Chemical abortion pills can cause dangerous complications including hemorrhage and infection, and complications are more likely when pills are dispensed without medical screening or follow-up care," president Marjorie Dannenfelser said in a statement. "State lawmakers and Congress must stand as a bulwark against the Biden administration's pro-abortion extremism."
Mifepristone is currently approved by the FDA up to 10 weeks into pregnancy. The drug is in a class called antiprogestational steroids and it works by blocking the activity of progesterone, a substance that helps sustain pregnancy.
The estimated number of women who have used mifepristone in the U.S. for medical termination of pregnancy through the end of June 2022 is approximately 5.6 million, according to the FDA. Since the drug's approval in September 2000, the FDA is aware of 4,213 cases with adverse reactions, including 28 deaths, linked to the pill's use.
"Mifepristone is safe when used as indicated and directed," the FDA said. "The FDA approved Mifeprex more than 20 years ago based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use. As of 2016, it can be used for medical termination of pregnancy up to 70 days of gestation. The FDA's periodic reviews of the postmarketing data for Mifeprex and its approved generic have not identified any new safety concerns with the use of mifepristone for medical termination of pregnancy through 70 days gestation."
Under the FDA's updated Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program:
• Mifepristone must be prescribed by a health care provider that meets certain qualifications and is certified under the Mifepristone REMS Program.
• In order to become certified to prescribe mifepristone, health care providers must complete a Prescriber Agreement Form.
• The Patient Agreement Form must be reviewed with and signed by the patient and the health care provider, and the risks of the mifepristone treatment regimen must be fully explained to the patient before prescribing mifepristone.
• The patient must be provided with a copy of the Patient Agreement Form and mifepristone Medication Guide (FDA-approved information for patients).
• Mifepristone may only be dispensed by or under the supervision of a certified prescriber, or by a certified pharmacy on a prescription issued by a certified prescriber.
• To become certified to dispense mifepristone, pharmacies must complete a Pharmacy Agreement Form.
• Certified pharmacies must be able to ship mifepristone using a shipping service that provides tracking information.
• Certified pharmacies must ensure mifepristone is dispensed to the patient in a timely manner.
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