FDA GOES HEAD TO HEAD WITH ABORTION ADVOCATES — The FDA said health providers prescribing abortion medication to people who aren’t pregnant are acting without its authorization, putting the Biden administration at odds with doctors and advocates using the drug to counter states’ abortion restrictions, POLITICO’s Ben Leonard reports . Backstory: Some telemedicine providers, including Choix , as well as in-person providers, have begun offering mifepristone, which stops the flow of hormones supporting a fetus in the uterus, before pregnancy as a way to expand access to abortion after the Supreme Court’s June decision overturning Roe v. Wade. Known as “advance provision,” advocates say the practice lets patients be prepared in case they need to have an abortion at a later date, and that it’s safe and effective. In December, the FDA allowed doctors to prescribe mifepristone via virtual appointments and mail the drugs to patients. Some abortion advocates, including the American College of Obstetricians and Gynecologists, have called for the FDA to remove all restrictions on the drug. The FDA disagrees. Abortion medication is regulated more tightly by the FDA than other drugs, restricting how the regimen can be prescribed. An FDA spokesperson told POLITICO that if mifepristone were prescribed before a patient is pregnant, providers couldn’t properly oversee care to ensure safety and effectiveness. Specifically, the agency is concerned that if patients were to take mifepristone weeks or months after getting a prescription filled, a medical professional might not be able to assess whether a pregnancy is intrauterine or ectopic or to date pregnancies properly. The drug is approved up to 70 days of gestation for abortions. Choix CEO Cindy Adam pushed back against the FDA in a statement to POLITICO, saying that restrictions on medication abortion are unnecessary and the regimen is safe. Choix offers “ongoing, supportive” care throughout the process, she said. WELCOME TO YOUR HALLOWEEN PULSE — Every year, U.S. emergency rooms see an average of 3,200 Halloween injuries — 55 percent due to pumpkin carving, 25 percent to falls and 20 percent to injuries associated with costumes and pumpkins, among other menaces. Stay safe out there, people, and send those news and tips to kmahr@politico.com and dpayne@politico.com . TODAY ON OUR PULSE CHECK PODCAST, Megan Wilson talks with Katherine Ellen Foley about the turmoil at the leading industry group for biopharmaceutical companies after the departure of its CEO — just as the Biden administration is set to implement a new law aimed at lowering drug prices. Plus, Chris Hammond, a Covid long-hauler, shares what life has been like for him and why he's not optimistic about additional Covid funding from Congress.
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