From: Lexology
Richard P. Church and Ryan J. Severson | K&L Gates
The new administration has had an immediate impact on the federal 340B Drug Discount Program (“340B Program”) with two significant developments in the first days since President Trump took office: (1) the withdrawal of the final 340B Program Omnibus Guidance, which was pending before the White House Office of Management and Budget (“OMB”); and (2) an expected delay in the effective date of the final rule issued by the Health Resources and Services Administration (“HRSA”) on 340B drug pricing and civil monetary penalties (“CMPs”) for drug manufacturers.
Our prior alert on the 340B Omnibus Guidance can be found here. Our recent alert on the HRSA final rule relating to 340B drug pricing and manufacturer penalties can be found here.