The changes were finalised after the FDA reviewed supplemental applications from Danco Laboratories and GenBioPro, the two companies that manufacture the drug in the United States….reports Asian Lite News
The US Food and Drug Administration has, for the first time cleared a passage for certified pharmacies to dispense abortion pills in the United States, Al Jazeera reported on Tuesday.
Previously, only a certified healthcare provider could order, prescribe, and dispense these pills. However, now the Pharmacies that have become certified to do so can dispense the drugs directly to someone who has a prescription from a certified prescriber. “Under the Mifepristone REMS Program, as modified, Mifeprex and it’s approved generic can be dispensed by certified pharmacies or under the supervision of a certified prescriber,” Al Jazeera reported citing the agency’s information, which it posted on its website on Tuesday.
The changes were finalised after the FDA reviewed supplemental applications from Danco Laboratories and GenBioPro, the two companies that manufacture the drug in the United States.
Mifeprex is the brand name for mifepristone, which, when combined with a second drug called Misoprostol, which has a variety of uses including miscarriage management, induces abortions up to 10 weeks into pregnancy in a procedure known as medication abortion, according to Al Jazeera.
According to the recent decision of the US Food and Drug Administration, Pharmacies can begin applying for certification to distribute the abortion pill Mifepristone from one of two manufacturers, and if it succeeds, they will be able to dispense it directly to patients.
The modifications included the permanent removal of restrictions on mail-order shipping of the pills and their prescription via telehealth – or remote healthcare.
CNN reported citing the Guttmacher Institute, a research group that supports abortion rights, and stated that medication abortion is used in more than half of abortions in the United States, and overtook surgical procedures for the first time in 2020.
The FDA’s decision comes just days after a new Justice Department legal opinion declared that federal law allows the US Postal Service to deliver abortion drugs – a move the Biden Administration is certain, would help protect abortion access in states that enacted bans in the aftermath of the Supreme Court’s decision to overturn Roe v. Wade.
The overturning of Roe vs Wade demonstrates the tangible impacts that it has on patients seeking access to medical procedures. On June 24, 2022, the Supreme Court of the US abolished abortion rights while overturning the constitutional right granted to women in a historical 1973 ruling called Roe vs Wade. (ANI)
