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.
Excerpt: Since the October 6, 2011, letter, Beacon Power and Abound Solar declared bankruptcy, making them the second and third recipients of a Section 1705 loan guarantee to do so. Recent reports have indicated that several other recipients remain in unstable financial condition.