Attorneys general from 22 states are calling on the Food and Drug Administration (FDA) to reverse a rule change allowing for remote prescriptions of abortion-inducing pills through the mail.
“In direct contravention of longstanding FDA practice and congressional mandate, the FDA’s rollback of important safety restrictions ignores both women’s health and straightforward federal statutes. We urge you to reverse your decision,” the letter states, adding that the authority to regulate abortion lies with the voters and their elected representatives.
Dangers of Mifepristone
In early January, the FDA made a regulatory change that allowed retail pharmacies to offer the drug mifepristone to people either in-store or by mail order, provided they obtain a prescription from a certified health care provider.Mifepristone is one of two drugs commonly used for medication abortions.
When the FDA first approved mifepristone back in 2000, it recognized that the drug carried “serious risks for women, including infection and bleeding,” the letter pointed out. To minimize risks, the FDA instituted several restrictions as part of a Risk Evaluation Mitigation Strategy (REMS) in 2007.
According to REMS, mifepristone can only be prescribed by a “qualified physician and administered in a hospital, clinic, or medical office and only by or under the supervision of such a physician,” the attorneys general said.
Until recently, the FDA had stuck with these requirements.
The agency’s rule change in the prescription and administration of mifepristone is not the result of an “analysis on how to help promote women’s health,“ the attorneys general claimed. Instead, the FDA justifies the move by citing a reduction of “burden” on the health care delivery system while asserting that the “benefits of the product outweigh the risks,” the letter states.
Though the drug poses risks to women at any point in pregnancy, the risks are highest in later pregnancy, the letter noted. An accurate determination of pregnancy can only be done in-person via ultrasound. As such, by permitting the remote use of abortion drugs, the FDA is “endangering the lives of women,” the letter insisted.
State Laws
The FDA updates will likely face challenges in 18 states that have laws mandating a medical professional be present when abortion drugs are administered. The laws of these states effectively ban prescribing abortion drugs via telemedicine.In the letter, the attorneys general point out that several states have already recognized that drugs like mifepristone can be dangerous when prescribed or administered remotely.
The Alabama Legislature has passed the Women’s Health and Safety Act, which insists that only a physician can prescribe or administer abortion drugs after an in-person examination. Such laws are lawful and necessary to protect women’s health, the attorneys general stated.
“Though the FDA has abdicated its responsibility to protect women’s health, we have not. To be crystal clear, you have not negated any of our laws that forbid the remote prescription, administration, and use of abortion-inducing drugs,” the letter said.
“The health and safety of our citizens—women and children included—is of paramount concern. Nothing in the FDA’s recent changes affects how we will protect our people.”
