A proposed law to set clear oversight authority over compounding pharmacies that make medicine on a large scale is on its way to a vote before the full Senate.
The legislation, which is intended to prevent another fungal meningitis outbreak, emerged from the Senate Health, Education, Labor and Pensions Committee on a voice vote Wednesday morning without any amendments. Infections linked to contaminated medicine made by New England Compounding Center last year have sicked 741 people across the nation with 55 deaths.
Under the proposed legislation, compounding manufacturers must register with the U.S. Food and Drug Administration and comply with good manufacturing processes. Traditional compounding pharmacies that mix smaller batches of drugs would remain under the purview of state regulators.
“Our bill makes it absolutely clear who is in charge of overseeing these compounding businesses and this report confirms that the tragic meningitis outbreak came on the heels of many reports about dangerous practices at poorly regulated large-scale compounders, and will happen again if we do not clarify oversight,” said Sen. Lamar Alexander, R-Tenn., the ranking Republican on the committee.
Tennessee is one of the hardest hit states by the outbreak with 152 illnesses and 15 deaths.
The report prepared by the committee noted that illnesses and deaths occurred because of compounding mistakes before the fungal meningitis outbreak. Between 1988 and 2005, at least 38 deaths and 210 injuries were linked to compounded drugs that were mislabeled, contaminated or caused lethal overdoses, the report said.
It also noted that a third of compounded drugs failed quality checks when the FDA conducted rounds of testing in 2001 and 2006.
Problems continue to exist even after the fungal meningitis outbreak.
“In the eight months since the NECC-caused meningitis infections, at least 48 compounding companies have been found to be producing and selling drugs that were contaminated or created in unsafe conditions,” the report said. “Ten drug compounders have issued national recalls because of concerns about contamination, and 11 drug compounders have been ordered by state licensing agencies to stop producing some or all drugs.”
Contact Tom Wilemon at twilemon@tennessean.com or 615-726-5961.
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