To embed, copy and paste the code into your website or blog: On May 17, 2021, the Biden Administration took its first major action impacting the 340B Drug Discount Program. In a forceful statement, the Administration made plain its views on a major controversy that has pitted drug manufacturers against 340B covered entities for the past year - proclaiming that drug manufacturers are violating the 340B statute by restricting covered entity access to 340B discounts for drugs dispensed through 340B contract pharmacies. Background As regular readers of our blog know, for a number of years the 340B Program has been at a crossroads. The 340B Program, overseen by the Health Resources and Services Administration (HRSA), was intended to provide a safety net pipeline for individuals in need of access to out-patient drugs. However, the 340B Program grew by leaps and bounds over the last fifteen years and, for many larger hospital systems, it transformed into a major source of revenue supporting a multitude of programs in those systems. At the same time 340B stakeholders faced an outdated structure in which the overarching 340B statutory framework failed to keep pace with the evolution of how health care is actually provided; court rulings restricted the ability of any entity other than the government to enforce statutory provisions; other court rulings resulted in affirmative withdrawal of HRSA administrative guidance or in HRSA openly questioning its ability to enforce guidance; and, it seemed like every day a new lawsuit challenging another aspect of 340B was filed.