What’s the news: At the urging of the AMA and the American College of Obstetricians and Gynecologists (ACOG), the Biden administration announced that it will take steps to protect patients’ access to mifepristone.
“Some states are saying that they’ll try to ban or severely restrict access to” mifepristone and other medications, President Joe Biden said in response to the Supreme Court’s 6–3 ruling in Dobbs v. Jackson Women’s Health Organization that overturned the decades-old Roe v. Wade precedent guaranteeing abortion rights nationwide.
“The American Medical Association and the American College of Obstetricians and Gynecologists wrote to me and Vice President Harris stressing that these laws are not based on evidence and asking us to act to protect access to care,” the president added. “They say by limiting access to these medicines, maternal mortality will climb in America.”
Read the letters from AMA and ACOG to the White House (PDF) and the Food and Drug Administration (FDA) on access to mifepristone (PDF).
Biden directed the Department of Health and Human Services “to take steps to ensure that these critical medications are available to the fullest extent possible and that politicians cannot interfere in the decisions that should be made between a woman and her doctor.” That includes when it is prescribed through telehealth and sent by mail.
In a statement, U.S. Attorney General Merrick Garland said the Department of Justice will “work with other arms of the federal government that seek to use their lawful authorities to protect and preserve access to reproductive care.”
Garland added that “the FDA has approved the use of the medication mifepristone” and that “states may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy."
Why it’s important: More than 20 years ago, the FDA approved mifepristone to safely end an early pregnancy. The drug is also commonly used to treat miscarriages. Access to mifepristone is increasingly at issue given its use to terminate pregnancies in home settings.
Ahead of the Dobbs ruling in June, the AMA and ACOG urged the Biden administration to remove or revise the drug’s current risk evaluation and mitigation strategies (REMS) to remove potential barriers to access to mifepristone. The two physician organizations also support the FDA’s authority to preempt state laws that further restrict access to the drug.
In December, the FDA removed a requirement included in the drug’s REMS that necessitated dispensing of the drug by a physician and required the first dose to be taken in the presence of the prescribing physician. However, several states have moved to further restrict mifepristone access and have continued in-person dispensing requirements, with 26 states limiting telemedicine access to the drug.
Mifepristone manufacturers are pursuing legal action to challenge these continued restrictions in states that enact them. Those legal actions could have far-reaching implications, not only affecting access to abortion care but possibly deciding whether states can place additional dispensing restrictions on FDA-approved drug products that are not included in the product approval and labeling.
Responding to the growing threat of overpolicing and surveillance of reproductive health services, the AMA House of Delegates last month adopted policy recognizing that it is a violation of human rights when government intrudes into medicine and impedes access to safe, evidence-based reproductive health services, including abortion and contraception.
Find out how—with abortion under attack—doctors are pushing back on criminalizing care.
Learn more: Gain additional background with this AMA Ed Hub™ JN Learning™ CME module on medication for early pregnancy termination.
Generic mifepristone manufacturer GenBioPro Inc. is challenging a Mississippi law that requires patients to consult a physician in person—rather than through telemedicine—to obtain a prescription for the medication, according to a Reuters news report. The company argues that the FDA’s safety regulations should preempt the Mississippi statute.
In this Leadership Viewpoints column, AMA President Jack Resneck, MD, detailed how the Dobbs ruling is an assault on women’s health and safe medical practice.
“States that end legal abortion will not end abortion—they will end safe abortion, risking devastating consequences, including patients’ lives,” Dr. Resneck wrote.
