WASHINGTON — Leaders of key U.S. Senate and House committees have agreed in principle on legislation to strengthen safeguards on so-called compounding pharmacies in the wake of a meningitis outbreak that killed 19 people in Michigan and injured hundreds of others a year ago.
Earlier this month, the Free Press reported on a House bill being introduced that sought to clarify federal authority over certain pharmaceutical providers and how it differed from the Senate version — potentially setting up a battle between the two chambers.
But in a news release Wednesday, a bipartisan group of leaders from the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor & Pensions signaled agreement on legislation that “clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation.”
Compounding pharmacies — a term traditionally applied to businesses that mix drugs for specific needs of a patient, but more recently applied to larger producers supplying compounds to hospitals and other health care practitioners — came under scrutiny after the meningitis outbreak last fall that affected 750 people nationwide, killing 64.
Linked to fungal contamination of injectable steroids from a Massachusetts center, the outbreak hit hardest in Michigan with 264 total cases. In Congress, the issue has revolved around how best to clarify when a pharmacy falls under Food and Drug Administration purview. States generally have oversight of traditional compounding pharmacies.
Energy and Commerce Committee Chairman Fred Upton, R-St. Joseph, on Thursday called the legislation “a major step forward” toward clarifying federal law. The exact legislative wording, however, was not immediately available for review.
A second part of the bill is expected to replace the various prescription-drug tracing laws at the state level by creating a new uniform framework for tracking drugs from the manufacturer to the pharmacy nationwide.
http://www.freep.com/article/20130926/NEWS06/309260169/1008/news06/Congressional-accord-reached-pharmacy-legislation-wake-meningitis-outbreak
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