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 to remarks you gave early in your tenure during a speech entitled, ‘Effective Enforcement and Benefit
To read EPA's February 1, 2013, response, click here. To read the committee's December 12, 2012, letter, click here.
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. … Maintaining the integrity of the 340B program is of the upmost importance, and we trust that you share our concerns.
To read the letter, click here.
To read the letter, click here. To read the NRC's February 19, 2013, response, click here.
To read the Food and Drug Administration's Response, click here. To read the initial letter to HHS, click here