Review of 340B Program Omnibus Guidelines Extended – Last week, the White House Office of Management and Budget (OMB) posted that the review of the 340B Program Omnibus Guidelines had been extended. The Health Resources and Services Administration (HRSA) submitted guidance on the 340B Program to the OMB in May for review. OMB’s website reflects that there is no legal deadline for its review to be completed. Once the OMB has completed its review, the proposed guidance will be published in the Federal Register for comment.

DOJ Hires Compliance Counsel to Assist in Charging Decisions –The U.S. Department of Justice (DOJ) recently revealed it is hiring a compliance counsel to assist DOJ prosecutors in assessing the effectiveness of companies’ corporate compliance programs. For information on the new compliance counsel’s role in the DOJ and the DOJ’s increased scrutiny on the effectiveness of corporate compliance programs.