food fights
FDA weighs stepping in on ultra-processed foods
Top FDA officials are weighing the regulation of ultra-processed foods, according to internal agency calendars obtained by STAT's Nick Florko.
Two officials met multiple times in February to discuss regulating products such as sodas, prepackaged cookies, and most breakfast cereals. Nutritionists suspect these manufactured foods increase people's risk for a variety of chronic diseases, though as of now, there is a dearth of rigorous research to back up those claims.
But don't get too stressed: The FDA is likely years — if not decades — away from serious regulation of these foods, Nick writes. Still, agency officials are publicly mounting pressure. Commissioner Robert Califf has spoken at various events about the potential risks of ultra-processed foods and met with advocates. He's told STAT directly that the agency can step in by putting benefits and harms onto the products' labels.
Read more from Nick about what the FDA can do and what advocates want to see.
coverage policy
Vertex sues HHS over fertility support access
One of the makers of Casgevy — the world's first CRISPR-based medicine — filed a lawsuit Monday intended to clear the way for the company to pay for fertility preservation services and treatment for people receiving the therapy, which can interfere with reproduction, STAT's Megan Molteni reports.
The suit challenges HHS's stance that Vertex's fertility support program would violate federal anti-kickback laws and accuses the agency of slow-walking a written determination. The FDA approved Casgevy for sickle cell disease treatment this December. While the therapy provided a glimmer of hope for people living with the disease, the process — including chemotherapy to remove bone marrow cells — comes with serious side effects including potential infertility.
Several methods of preserving fertility, such as freezing sperm or eggs, are not covered by many insurers including Medicaid. And the majority of the estimated 100,000 Americans with sickle cell disease rely on Medicaid, which is where the lawsuit comes in. More from Megan on the coverage battle.
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