Letter to FDA on Meningitis Outbreak
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 Benefits to Public Health.’ In that speech, you noted the need to ‘follow-up on signals indicating problems’ and promptly ‘assess whether or not a company has made required changes in its practices.’ In order for the committee to fully understand why FDA never re-inspected NECC or took any meaningful enforcement action against the company, despite repeatedly asserting that it could and would do so, the agency must cooperate with the committee’s investigation and fully respond to our request for internal communications and memoranda.
To read the letter, click here.
To read a related press release, click here.