Status Of GAO Recommendations To Improve 340B Drug Pricing Program Oversight

In its September 2011 report, GAO found that the Health Resources and Services Administration’s (HRSA) oversight of the 340B Program was inadequate to provide reasonable assurance that program participants—covered entities and drug manufacturers—were in compliance with program requirements. Specifically, GAO found the program:

Primarily relied on covered entities and manufacturers to police themselves and ensure their own compliance with 340B Program requirements, and engaged in few other activities to oversee the program and ensure its integrity. For example, although HRSA had the authority to conduct audits to determine whether program violations had occurred, at the time of . . .