On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding pharmaceutical manufacturer and covered entity participation in the 340B Drug Discount Program (“340B Program”). A copy of the Proposed Guidance is available here. While not a formal rulemaking, HRSA has requested input from stakeholders before the Proposed Guidance is finalized. Comments on the Proposed Guidance are due to HRSA on or before Tuesday, October 27, 2015.

The Proposed Guidance aims to “provide increased clarity in the marketplace for all 340B Program stakeholders and strengthen HHS’s ability to administer the 340B Program.” 80 Fed. Reg. 52,300 (August 28, 2015). It remains unclear, however, whether and to what extent HRSA can require compliance with the views articulated in the Proposed Guidance once the document is finalized. The forthcoming court decision in PhRMA’s pending legal challenge to HRSA’s orphan drug “interpretive rule” may provide direction regarding the degree to which such guidance is binding on 340B Program participants.