Entries by Catherine Y. Starks

29 05 '26

Most-Favored-Nations Drug Pricing Policy: White House Quietly Releases Report Describing Voluntary MFN Deals

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On May 6, 2026, the White House Council of Economic Advisors (CEA)[1] discretely released the first report quantifying its view of the projected savings generated by the administration’s Most-Favored-Nation (MFN) drug pricing policy framework, based on existing MFN pricing agreements and expectations for future MFN agreements. According to the report, the MFN framework is expected to generate an estimated $529B in domestic savings and a 30% decrease in net prices for drugs in the U.S. over the next 10 years.

21 12 '23

Forthcoming HHS Regulatory Actions and Opportunities Relevant for Pharmaceutical Manufacturers for the Rest of this Year and Next

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Pharmaceutical manufacturers need to note some key forthcoming regulatory actions and opportunities which the Department of Health and Human Services (“HHS”) has recently published. Meena Datta and Catherine Starks give a bird’s eye view of the key points, the key dates and the stage which each new rule has reached.

15 12 '23

HHS-OIG Rejects Calls for New Safe Harbors for Financial Support to Patients Enrolled in Clinical Trials

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Earlier this month, the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) declined to establish new safe harbors that would protect arrangements under which clinical trial sponsors provide financial support to participants. Catherine Starks, Deeona Gaskin, Meenakshi Datta, and Taylor Andelman report.