In A First, US FDA Officially Approves The Sale Of Abortion Pills At Retail Pharmacies

Even though more states are trying to ban medical abortion, the FDA has said that soon pharmacies in the United States will be able to sell abortion pills.

"Under the Mifepristone REMS Program, as modified, Mifeprex and its approved generic can be dispensed by certified pharmacies or under the supervision of a certified prescriber," the agency said on its website Tuesday.

Since abortion access was severely limited by the Supreme Court's decision to overturn the historic Roe v. Wade ruling and the subsequent state restrictions, President Joe Biden's administration has debated the best way to maintain abortion rights.

The new regulation change might have this effect.

The two US-based medicine makers, Danco Laboratories and GenBioPro, sent in new applications, which the agency reviewed before approving the final changes.

Before pharmacies can start giving out Mifepristone to patients who have a prescription from a licensed doctor, they must first get certification from one of the companies that make it.

The Food and Drug Administration (FDA) first hinted at these changes in December 2021 when it said it would remove some risk evaluation and mitigation strategies (REMS) from the pill.

These REMS had been in place since the FDA approved the pill in 2000, but they were temporarily removed in 2021 because of the COVID-19 pandemic.

Among the modifications were the unrestricted legalization of telehealth prescriptions and mail-order shipment of the medications.

Mifepristone, sold under the brand name Mifeprex, is an abortion pill.

When taken with Misoprostol, which is used for many things, including treating miscarriages, it can cause a miscarriage or an abortion up to 10 weeks into a pregnancy.

Human rights advocates for abortion access argue there is no risk of addiction or overdose while using the pill.

Abortion pills are available over the counter in various countries, including India and Mexico.

"Today¡¯s news is a step in the right direction for health equity," Planned Parenthood President Alexis McGill Johnson said in a statement.

"Being able to access your prescribed medication for 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," Johnson added.

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Generic mifepristone manufacturer GenBioPro said that despite the regulatory change, not everyone would have the same level of access to the drug.

Since the Supreme Court of the United States overturned the 1973 Roe v. Wade verdict, abortion laws, some of which specifically target Mifepristone, have gone into effect in more than a dozen states.

Women in those states might be able to go to other states to get abortion drugs.

Roe vs. Wade

The new FDA action, according to Marjorie Dannenfelser, head of the anti-abortion group SBA Pro-Life America, puts the lives of mothers and unborn children in danger.

American Psychological Association

"State lawmakers and Congress must stand as a bulwark against the Biden administration¡¯s pro-abortion extremism," she said.

According to the FDA's database, Mifepristone has been linked to negligible deaths.

Since its approval in September 2000, an estimated 4.9 million people have taken the tablet. As of June 2021, there have been 26 reported fatalities due to consuming the drug.

(With agency inputs)

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