WASHINGTON, Jan 3 (Reuters) – The U.S. Food and Drug Administration (FDA) is allowing retail pharmacies to offer abortion pills in the United States for the first time, the agency said on Tuesday, as more states seek to ban medication abortion.
Pharmacies can apply for certification to distribute abortion pill mifepristone with one of the two companies that make it, and if successful they will be able to dispense it directly to patients upon receiving a prescription from a certified prescriber.
The FDA had first said it would be making those changes in December 2021 when it announced it would relax risk evaluation and mitigation strategies, or REMS, on the pill, that had been in place since the agency approved it in 2000 and were lifted temporarily by the government in 2021 due to the pandemic.
Danco Laboratories and GenBioPro, the two companies that make the drug in the United States, submitted supplemental applications that have now been approved by the FDA.
“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 said on its website on Tuesday.
Mifeprex is the brand name version of mifepristone, which in combination with a second drug called misoprostol that has various uses including miscarriage management, induces an abortion up to 10 weeks into a pregnancy in a process known as medication abortion.
The announcement will not provide equal access to all people, however, GenBioPro, which makes the generic version of mifepristone, said in a statement.
Abortion bans, some targeting mifepristone, have gone into effect in more than a dozen states since the U.S. Supreme Court overturned the constitutional right to terminating pregnancies when it scrapped its landmark 1973 Roe v. Wade ruling last year.
Retail pharmacies will have to weigh whether or not to offer the pill and determine where they can do so.
“We’re reviewing the FDA’s updated Risk Evaluation and Mitigation Strategy (REMS) drug safety program certification requirements for mifepristone to determine the requirements to dispense in states that do not restrict the dispensing of medications prescribed for elective termination of pregnancy,” a spokesperson for drugstore chain owner CVS Health (CVS.N) said.
A spokesperson for Walgreens, one of the largest U.S. pharmacies, said the company was also reviewing the FDA’s regulatory change.
Reporting by Ahmed Aboulenein; Additional reporting by Eric Beech in Washington, Shivani Tanna, Rahat Sandhu, and Kanjyik Ghosh in Bengaluru; Editing by Himani Sarkar
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