United States: The US Food and Drug Administration (FDA) will let retail pharmacies sell abortion pills in the US for the first time, the agency announced even if more states want to outlaw pharmacological abortion.
“Under the Mifepristone REMS Program, as modified, Mifeprex and it is approved generic can be dispensed by certified pharmacies or under the supervision of a certified prescriber,” the agency noted.
The regulatory adjustment may increase access to abortions as President Mr. Joe Biden’s administration struggles with how best to defend abortion rights following the landmark Roe v. Wade decision’s overturning by the Supreme Court and the state restrictions that followed it last year.
The government finally approved the adjustments after considering supplemental applications from Danco Laboratories and GenBioPro, the two US manufacturers of the medicine. Pharmacies can begin submitting certification applications to one of the two companies that manufacture the abortion pill Mifepristone. If approved, they will be authorized to deliver it directly to patients after receiving a prescription from a licenced physician.
When the FDA first declared it would loosen some risk evaluation and mitigation strategies, or REMS, on the pill that had been in place since the agency approved it in 2000 and had been temporarily suspended in 2021 due to the COVID-19 pandemic, it did so in December 2021.
The modifications included the permanent removal of limitations on the prescription of the medications and their mail-order delivery via telehealth, or remote healthcare. Mifeprex, the brand name for mifepristone, induces abortions up to 10 weeks into pregnancy by the use of a second drug called Misoprostol, which also has a number of purposes, including the management of miscarriages.
The pill has a long history of being effective and safe, with no risk of overdose or addiction, according to pro-abortion activists. Women can purchase them without prescription in a number of nations, including Mexico and India, to induce abortion.
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