UNITED STATES: The U.S. Food and Drug Administration (FDA) made a regulatory change on Tuesday that will allow retail drugstores to dispense abortion pills in the United States for the first time, despite the fact that more states want to forbid pharmaceutical abortion.
The regulatory change will increase access to abortions as President Joe Biden’s administration struggles with how to best defend abortion rights in the wake of the Supreme Court’s decision to overturn the crucial Roe v. Wade decision and the state restrictions that followed that decision, which severely curtailed those rights.
Pharmacies can begin applying for certification to distribute the abortion drug mifepristone with one of the two manufacturers; if successful, they will be authorised to deliver it directly to patients after acquiring a prescription from a licenced physician.
In December 2021, the FDA first announced that it would relax some risk assessment and mitigation measures, or REMS, on the drug that had been in place since the agency approved it in 2000 and had been temporarily halted in 2021 due to the COVID-19 pandemic.
The modifications included the permanent removal of limitations on the delivery of the medications by mail-order and their prescription by telehealth.
The FDA finalised the modifications on Tuesday after taking into account supplemental applications from the two companies that make the medicine in the US, Danco Laboratories and GenBioPro.
The agency said on its website that “Under the Mifepristone REMS Program, as modified, Mifeprex and its approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber.”
The brand-name form of mifepristone, known as Mifeprex, induces an abortion up to 10 weeks into a pregnancy when combined with a second medication, misoprostol, which has a number of purposes, including the management of miscarriages.
The pill, as per pro-abortion activists, has a long history of being effective and safe, with no overdose or addiction risk.
Women can purchase them for abortion inducement without a prescription in a number of nations, including Mexico and India.
Alexis McGill Johnson, president of Planned Parenthood, stated in a statement that “today’s news is a step in the right direction for health equity.”
However, GenBioPro, which manufactures the generic form of mifepristone, stated in a statement that not everyone will have equal access to the regulatory modification.
The recent FDA action, according to SBA Pro-Life America’s president, Marjorie Dannenfelser, puts women’s safety and the lives of unborn babies in peril.
In a statement, she insisted that Congress and state legislators “must act as a bulwark against the Biden administration’s pro-abortion fanaticism.”
Since the U.S. Supreme Court abrogated the constitutional right to terminate pregnancies by overturning the 1973 Roe v. Wade decision last year, abortion bans—some of which target the drug mifepristone—have taken effect in more than a dozen states.
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