Legislation has been introduced in both houses of Congress that would provide FDA with the power and flexibility it needs to define the regulatory requirements for high-risk compounding operations and the authority to inspect those that engage in interstate commerce.
The similarity of the bills reflects the time both houses have had to do a thorough vetting of the issues and listen to the concerns of the various constituencies, as well as to frame and compare initial proposals, in the effort to develop a viable legislative pathway.
Both bills provide the agency with some latitude in deciding how best to achieve the specified goals.
The House bill is sponsored by Rep. Edward Markey (D-MA), who represents the district in which the New England Compounding Center (NECC) was located. NECC was responsible for the major crisis that broke out last fall when tainted injectable methylprednisilone acetate caused an outbreak of fungal meningitis that has resulted in 55 deaths and more than 740 illnesses in 20 states (see IPQ November Special Report).
Markey is currently running for the Senate seat vacated when Massachusetts Senator John Kerry was confirmed as Secretary of State. Markey built his new legislation on the bill he proposed last fall in the immediate wake of the emerging crisis, which did not have time to work its way forward as the Congressional session ended.
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