September 12, 2024 | New York Law Journal
The Future of FDA Policy: Reflections From the Summer of 'Chevron'Sheppard Mullin attorneys discuss 'Loper Bright Enterprises v. Raimondo' and include the considerations stemming from the decision, both generally and with respect to FDA practice, specifically. They write: "Now, after having spent the summer pouring over cases, articles, and thought leadership on the matter, we're not sure the win is so sweeping—especially in the U.S. Food & Drug Administration arena."
By Scott Liebman, Dominick DiSabatino and Audrey Mercer
8 minute read
January 09, 2023 | New York Law Journal
Industry Fights Back Against Restrictions on Pharmaceutical Manufacturers' Ability To Offer Drug Cost-Sharing SubsidiesIn 2022, the Office of Inspector General and at least two federal courts took a clear stance against pharmaceutical manufacturers' attempts to offer cost-sharing subsidies to Medicare beneficiaries for certain drugs, but the industry is fighting back. Pharmaceutical manufacturers and lobbying groups are challenging these administrative restrictions in a concerted effort to increase access to life-saving medications.
By Dominick DiSabatino, Audrey Crowell and Scott Liebman
15 minute read
March 23, 2022 | New York Law Journal
OIG Advisory: Yet Another Favorable Decision for Medical Device ManufacturersMedical device manufacturers should pay close attention to this trend when considering trial designs and patient populations.
By Scott Liebman and Dominick DiSabatino
7 minute read