{"id":282684,"date":"2023-01-04T06:46:55","date_gmt":"2023-01-04T12:46:55","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=282684"},"modified":"2023-01-08T21:49:50","modified_gmt":"2023-01-09T03:49:50","slug":"fda-retail-pharmacies-abortion-pills-prescription","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/fda-retail-pharmacies-abortion-pills-prescription\/","title":{"rendered":"FDA announces retail pharmacies can dispense abortion pills with a prescription"},"content":{"rendered":"
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The abortion pill can now be sold through retail pharmacies with a prescription, according to\u00a0the U.S. manufacturer of the abortion pill, Danco Laboratories. The change made on January 3, 2023, was not yet published<\/a> by the U.S. Food and Drug Administration (FDA) when it grabbed the attention of multiple media outlets due to an announcement<\/a>\u00a0released by Danco.<\/p>\n

“Pharmacies who become certified in the Mifepristone REMS Program may dispense Mifeprex\u00ae directly to patients upon receipt of a prescription from a certified Mifeprex\u00ae prescriber, provided a Prescriber agreement is provided or on file with the certified pharmacy,” Danco’s\u00a0press release<\/a>\u00a0states.<\/p>\n

REMS is a safety requirement put in place by the FDA to monitor a limited number of drugs with specific concerns.<\/p>\n

“Danco has worked to ensure that the REMS modifications will not disrupt the medication abortion services that are currently being provided by existing Mifeprex providers whether through clinics, medical offices, hospitals or telehealth utilizing our mail order pharmacies, American Mail Order Pharmacy<\/a> (AMOP) and Manifest Pharmacy<\/a>. We expect that there may be an adjustment period for Mifeprex\u00ae providers as we implement the changes to the REMS. Current providers will be able to continue provision of Mifeprex under their current Prescriber Agreements for a number of months before an updated Prescriber Agreement must be put in place,” Danco also\u00a0wrote<\/a>.<\/p>\n

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In response, Susan B. Anthony Pro-life America\u00a0pointed out<\/a> that “[m]ultiple peer-reviewed studies<\/a> confirm that women are at risk of\u00a0severe side effects<\/a> after taking chemical abortion pills, including hemorrhaging, the need for follow-up surgery, and even death. Studies have found that\u00a0chemical abortion has four times the complication rate of surgical abortion<\/a>, and these risks only increase with advanced pregnancy and lack of medical supervision. Peer-reviewed research from Charlotte Lozier Institute has also\u00a0found<\/a>\u00a0that after a chemical abortion there is a 53% greater risk for an ER visit for abortion complications than after a surgical abortion.”<\/p>\n

An update to the FDA’s website<\/a>\u00a0came later in the day, and states, “As of June 30, 2022, there were 28 reports of deaths in patients associated with mifepristone since the product was approved in September 2000, including two cases of ectopic pregnancy (a pregnancy located outside the womb, such as in the fallopian tubes) resulting in death; and several fatal cases of severe systemic infection (also called sepsis).”*<\/p>\n

Will retail pharmacies agree to dispense abortion drugs?<\/strong><\/p>\n

“For the first time, retail pharmacies, from corner drugstores to major chains like CVS and Walgreens, will be allowed to offer abortion pills in the United States under a regulatory change made Tuesday by the Food and Drug Administration. The action could significantly expand access to abortion through medication,” New York Times reported<\/a>.<\/p>\n

In February of 2022<\/a>, a\u00a0Bloomberg\u00a0writer<\/a>\u00a0claimed that\u00a0Walgreens Boots Alliance Inc.<\/a>\u00a0wasn’t seeking pharmacy certification, but noted at the time that\u00a0CVS\u00a0Health Corp.<\/a>\u00a0would not comment on whether it planned to do so. It is unknown if that will change.<\/p>\n

Pharmacy Agreement<\/strong><\/p>\n

The Pharmacy Agreement<\/a> states, “Pharmacies must designate an authorized representative to carry out the certification process and oversee implementation and compliance with the Mifepristone REMS Program on behalf of the pharmacy. Healthcare settings, such as medical offices, clinics, and hospitals, where mifepristone will be dispensed by or under the supervision of a certified prescriber in the Mifepristone REMS Program do not require pharmacy certification.”<\/p>\n

The pharmacy is required to, among other things:<\/p>\n