By David Morgan | Reuters – 6 hrs ago
WASHINGTON (Reuters) - Democratic and Republican lawmakers said on Thursday they would alter the regulation of drug compounding pharmacies in hopes of preventing more crises like the rare fungal meningitis outbreak that has now cost 32 lives.
The outbreak of 461 cases in 19 states has been linked to tainted steroid injections from a Massachusetts pharmacy and led to public condemnation of the U.S. Food and Drug Administration and state pharmacy regulators for failing to act against known problems over the course of a decade.
A Thursday hearing before the Senate Health, Education, Welfare and Pensions Committee brought the strongest signs so far of bipartisan willingness to approve legislation that could break down the current separation of powers between the FDA and individual state regulators charged with overseeing drug compounding.
"Our first order of business (is) to answer these questions: not just whose job was it to prevent this tragedy, but whose job will it be to make sure it doesn't happen again," saidRepublican Senator Lamar Alexander of Tennessee, the state that has become the outbreak's epicenter with 83 cases and 13 deaths.
Alexander suggested the FDA could be given powers to certify individual states as the primary regulators of large-scale compounders and withdraw certification from those that fall short.
Senator Pat Roberts, a Kansas Republican long associated with efforts to reform the current regulatory framework, said the outbreak's repeated loss of life underscores the need for "appropriate measures" to protect patients.
"In the face of such a tragedy, it is natural to want to take action. And we will," said Senator Tom Harkin, the Iowa Democrat who chairs the Senate committee.
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