lunes, 25 de marzo de 2024

SCOTUS’ abortion pill mifepristone case is really about the FDA Sarah Owermohle By Sarah Owermohle March 25, 2024

https://www.statnews.com/2024/03/25/supreme-court-mifepristone-abortion-pill-oral-arguments/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=299647194&_hsenc=p2ANqtz--pifx3bLTi8luiDNyowJAxvbVwmUxuZ-Yn2slYtrcrNwW8_4ZV8VfuGIzzJAWMqATB8HsrBV6IooQ7gjeTQp2NsDAlGQ&utm_content=299647194&utm_source=hs_email Last week, the Texas Medical Board proposed draft guidance Friday in an attempt to clarify what constitutes emergency grounds for a legal abortion after pressure from the state Supreme Court and widespread uncertainty among physicians. The board’s language largely drew from existing state legislation, and its president, Sherif Zaafran, noted that physicians who deem an abortion to be medically necessary would be expected to document how the risk of death or major impairment was determined. The board would not issue a list of conditions that constitute a medical emergency, arguing that circumstances vary considerably and the same condition could be an emergency or not depending on context. Response to the guidance has been mixed — one woman who was denied an abortion as emergency medical care in Texas told the board she was “hopeful” but “skeptical” the proposal would help physicians. STAT’s Olivia Goldhill has more on the details of the guidance. Meanwhile, the U.S. Supreme Court will hear opening arguments tomorrow in an abortion medication case that pharmaceutical companies warn could upend the industry and paralyze drug development. Mifepristone was first approved by the Food and Drug Administration in 2000 for abortion up to seven weeks of pregnancy. That approval was later extended to 10 weeks, and eventually the in-person dispensing requirement was removed. Now, in the wake of the overturning of Roe v. Wade, both those later changes could be reversed after a Fifth Circuit Court of Appeals’ ruling. In addition to the clear ramifications for reproductive rights across the country, pharmaceutical companies and former health officials have argued that reversing the FDA’s decisions would upend and politicize otherwise routine regulatory review processes. “This is a dagger at the heart of the entire industry,” said Ovid Therapeutics CEO Jeremy Levin. Read more from STAT’s Sarah Owermohle about the far-reaching ramifications of the case.

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