The United States Food and Drug Administration released last Thursday, December 16, an updated policy on the use of the abortifacient drugs Mifeprex, whose generic name is mifepristone, that is used with misoprostol "to end a pregnancy 70 days gestation."
The Food and Drug Administration's new policy underscored that it has previously approved the use of Mifeprex following its Risk Evaluation and Mitigation Strategy (REMS) conducted on the drug in 2019. The said 2019 REMS specified the criteria for prescribing the said drug to patients who wish to terminate their pregnancy, which includes being "ordered, prescribed, and dispensed by or under the supervision of a healthcare provider who prescribes and who meets certain qualifications."
The FDA highlighted that such a prescription is limited to an identified group of providers who are mandated to prescribe Mifeprex using a Prescriber Agreement Form and are to provide patients with the Mifeprex Medication Guide. The FDA stated that, as update to the 2019 REMS, patients are now to submit a signed "Patient Agreement Form" following counseling on it and that the drug could only be dispensed by certified pharmacies. The FDA, however, warned that such pills be bought online.
"Do Not Buy Mifeprex or its Approved Generic Over the Internet. You should not buy Mifeprex or its approved generic over the Internet because you will bypass important safeguards designed to protect your health," the FDA said.
"Mifeprex and its approved generic have special safety restrictions on how it is distributed to the public. Also, drugs purchased from foreign Internet sources are not the FDA-approved versions of the drugs, and they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities," the department added.
During the pandemic, the FDA eased out on its policy for the use of mail-in abortion pills by removing the need for in-person consultation of patients. This move supersedes a ruling made by former President Bill Clinton in 2000 that allows abortion pills to be acquired only in person, which was then enforced thereafter by former Presidents George Bush, Barack Obama, and Donald Trump.
But Trump filed an appeal in the Supreme Court regarding the said FDA policy due to the danger of abortion facilities giving out the pills without prior examination. The Supreme Court sided with Trump on it last January. Yet the Democrats, almost a month after Biden's seat in office, have already urged that abortion pills by mail be legalized.
Meanwhile, states have made protections in their level regarding the FDA policy such as Texas Governor Greg Abbott who approved Senate Bill 4 in September, just weeks after the controversial but effective Texas Heartbeat Act was allowed to stay by the Supreme Court.
While South Dakota Governor Kristi Noem released Executive Order 2021-12 that similarly bans the use of abortion pills by telemedicine. Noem called her Executive Order a "block" on the "war on the unborn" that Biden and pro-choice groups have waged. Last month, South Dakota legislators have heeded Noem's request to hear the banning of abortion pills this December.
"This means mothers will take the abortion pill at home with the possibility of hemorrhaging to death from undiagnosed ectopic pregnancy or adverse impacts of the drug. She'll then go into early labor, deliver the dead child into a toilet, and flush her baby into the sewer system," Live Action said in a statement released also on Thursday.
The pro-life organization raised in its statement that Mifeprex was put under the REMS in April 2011 because of reported adverse effects that included death. The group also exposed that the FDA policy reinstates what it decided during the pandemic--a matter indicated not in the policy itself but in the Question And Answer Section on the drug in the FDA website.
"FDA determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks," the FDA said in response to the question on the determining factors to its December16 policy.
"The modifications to the Mifepristone REMS Program will consist of: (1) removing the requirement that mifepristone be dispensed only in certain healthcare settings, specifically clinics, medical offices, and hospitals (referred to as the "in-person dispensing requirement"); (2) adding a requirement that pharmacies that dispense the drug be certified," they said.