A Supreme Court case led by a group of anti-abortion doctors and dentists against the FDA’s approval of mifepristone attempts to block access nationwide.in June 2022, the author of the opinion, Justice Samuel Alito, claimed that the Court was returning the authority to regulate abortion “to the people and their representatives.
In 2016, the FDA lowered the dosage to 200 milligrams, which reduces side effects such as nausea, and extended its approved use through. The agency also allowed any qualified healthcare provider, including nurses, midwives and physician’s assistants, to dispense the pills and reduced the number of required appointments to one.This past April, Kacsmaryk issued a decision invalidating the FDA approval of mifepristone outright.
Hundreds of pharmaceutical executives have spoken out against the lower court rulings, stating that allowing this kind of challenge to the drug approval process could destabilize the drug market in the United States. Pharmaceutical companies and the trade association PhRMA have also filed briefs in the case, opposing the rulings.
“I’ve been prescribing mifepristone for 23 years. It’s very safe. I have never even seen a patient hospitalized,” said Dr. Linda Prine, who works with telemedicine abortion provider Aid Access. Though the FDA loosened some of the restrictions on mifepristone, it has maintained others, such as requiring healthcare providers and pharmacies to be certified with the drug company before dispensing the medication, which limits the number of providers, and requiring patients to sign an informed consent form. According to the American College of Obstetricians and Gynecologists, these restrictions are medically unnecessary and burdensome to people seeking the medication.
“ the way FDA authority is structured, the secretary of HHS has a lot of authority to override scientists at the FDA,” said University of California, Davis, law professor Mary Ziegler. Although Cohen said that reviving Comstock may not have an immediate effect during the Biden administration because the FDA has discretion to allow continued use of mifepristone in accordance with current science, he notes that the situation could change if Trump wins the 2024 election.
Asked whether she would still prescribe by telemedicine if SCOTUS were to reinstate the 2000 regimen, Prine equivocated: “It depends on the fine print and what the ruling actually says. But if there’s any way at all that we can read into it any wiggle room, we’ll just keep providing.”
Source: Law Daily Report (lawdailyreport.net)
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