The Bridgewater, N.J., firm maintains that cancer patients could be hurt by CMS' reduced coverage proposal for these antianemia agents.
Like Amgen, Ortho Biotech has taken issue with CMS' proposal to limit coverage of erythropoiesis-stimulating agents (ESAs). Ortho Biotech said CMS should pay heed to what the FDA has approved in its product labeling. The Bridgewater, N.J., firm maintains that cancer patients could be hurt by CMS' reduced coverage proposal for these antianemia agents, adding that others, such as medical associations, health professionals, and patients, have come to the same conclusion. To view the full statement from the maker of Procrit (epoetin alfa), check out
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.