Excerpt: After past tragedies, federal, state, and local entities have reviewed what steps should be taken to prevent future tragedies from occurring… A helpful starting point for the committee’s inquiry is to examine the current and past efforts by federal agencies, in particular those of HHS, to assess and improve upon our mental health system in reaction to previous tragedies.
Excerpt: The few communications FDA has produced to the committee from the account of one district office employee raise new and troubling questions about the agency’s oversight of NECC after the December 2006 Warning Letter up until the recent outbreak, including why FDA failed to re-inspect the company’s facility. FDA’s repeated inaction is even more troubling in that it runs counter t
Excerpt: By its inaction, HRSA essentially turned a blind eye to entities who no longer should have been participating in the 340B program, allowing them to improperly reap the benefits of deeply discounted 340B drugs. Only last year did HRSA finally begin to ensure that participants continued to be eligible.
Excerpt: During the past month, we have heard from a number of concerned citizens, including parents, law enforcement officials, health care providers, state and local officials, and our colleagues in Congress, about the impending release of the non-tamper-resistant versions of these opioids.