On January 30, 2017, the proposed 340B Drug Pricing Program (the “340B Program”) Omnibus Guidance (the “Guidance”) first issued by the Health Resources and Services Administration (HRSA) in August of 2015 was withdrawn from the Office of Management and Budget (OMB) review process.  It is widely believed that the “cause of death” for the Guidance was the Trump Administration’s January 20, 2017 Memorandum (the “Memorandum”) directing agencies to immediately withdraw all unpublished regulations pending before OMB.^[1]
Continue Reading The 340B Program Omnibus Guidance: Not Ready for Prime Time