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Lucy Chard
5 Jan 2023

Abortion pills can now be sold in retail pharmacies according to the US FDA

In the US, retail pharmacies will be allowed to sell abortion pills for the first time, after latest approval is granted by the FDA. 

After the overturning of the 1973 landmark ruling of Roe v Wade in June 2022, President Joe Biden’s administration have been working to increase abortion access and protect abortion rights, even in those states which have upheld the new ruling. 

The abortion pill mifepristone (under the brand name Mifeprex) was first approved by the US FDA in 2000 for medical termination of pregnancy. In combination with the drug misoprostol, Mifeprex has a range of uses such as miscarriage management and inducing abortion up to 10 weeks. Now, pharmacies can apply for certification to distribute the medication with one of the companies that make it, Danco Laboratories and GenBioPro. Once they have received certification they would be able to dispense the pill to patients who have gained a prescription. 

The medication had been used in accordance with strict risk evaluation and mitigation strategies since 2000, but these were temporarily lifted during the COVID-19 pandemic. Since, the FDA has announced that it would be relaxing some of those reinstated strategies, to make the drug more accessible for patients. Some of these changes included the removal of restrictions on mail order shipping of the pills and the gaining of a prescription via telehealth, the use of which has soared since the pandemic. 

FDA approval comes after Danco Laboratories and GenBioPro submitted supplemental applications for the drug to be distributed in pharmacies in the USA.

"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 agency posted on its website.

The move is supported by abortion rights activists, who iterate that the abortion pill has been proven to be safe and effective for use, and in many countries, such as India and Mexico, can be bought for use without the need for a prescription. 

"Today's news is a step in the right direction for health equity," Planned Parenthood President Alexis McGill Johnson stated, "Being able to access your prescribed medication abortion through the mail or to pick it up in person from a pharmacy like any other prescription is a game changer for people trying to access basic health care." 

However, in the US, the new regulations don’t necessarily translate to equal access to healthcare with the abortion bans put in place in several states still giving rise to the prohibition of abortion pills, meaning women in need may have to travel across state boundaries to obtain the medication. 

Lucy Chard
Digital Editor - Pharma

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