Eli Lilly demands comprehensive claims data from participating hospitals or faces loss of price breaks. The U.S. FDA convenes a closed-door meeting with rare disease groups to address regulatory challenges.
Eli Lilly has issued an ultimatum to about 50 hospitals enrolled in the federal 340B drug discount program: submit detailed claims data over the next five days or risk losing the mandated price breaks, STAT reports. The pharmaceutical giant made this demand after announcing a policy last January aimed at reducing duplicate discounts paid to participating hospitals. For several years, more than 2,300 hospitals have complied with this requirement, but Lilly has identified around 1,000 larger hospital systems that have yet to meet the new standards.
Meanwhile, the U.S. Food and Drug Administration (FDA) is hosting a closed-door roundtable discussion on Wednesday involving over a dozen groups advocating for rare disease treatments. The meeting will feature FDA Acting Commissioner Kyle Diamantas and other senior agency officials in private conversation with at least 10 rare disease organizations to discuss advancing therapies that often face rigorous approval processes. This comes amid ongoing uncertainty in the rare disease community, following several initial rejections of drug applications by former Commissioner Marty Makary, who recently resigned.
These developments highlight the complex challenges facing both pharmaceutical companies and regulatory agencies as they navigate the intricacies of drug pricing and approval for specialized patient populations.
