Wednesday, August 21, 2013

Bill gives FDA oversight of compounding manufacturers August 21, 2013

Written by
Christopher Behnan
Daily Press & Argus






Legislation creating federal oversight of companies that make pharmaceutical compounds most likely would have prevented a fungal meningitis outbreak that has claimed eight Livingston County lives, bill sponsors said.
The bipartisan Pharmaceutical Quality, Security and Accountability Act would give the U.S. Food and Drug Administration oversight of businesses that mass-produce compounded medications and distribute them to clinics nationwide.
The former New England Compounding Center in Massachusetts, believed to have distributed tainted steroids that led to the meningitis outbreak, would have qualified as a compounding manufacturer under the bill.
Michigan Pain Specialists in Genoa Township was among the clinics that received and issued tainted steroid injections produced by New England Compounding Center.
Had the Senate bill been in place about a year ago, the FDA would have identified problems at the Massachusetts facility and shut it down and avoided the outbreak that has caused 22 Michigan deaths, including eight deaths in the county, according to the Senate Health, Education, Labor and Pensions, or HELP, committee.
“Our goal with this bill is to help put an end to health crises resulting from poorly regulated compounding manufacturers and make it clear who is on the flagpole — who is in charge and accountable for oversight of these compounding manufacturers and who is accountable for pharmacies,” said the bill’s sponsor, U.S. Sen. Lamar Alexander, R-Tenn., in a statement.
The most recent outbreak-related deaths in the county — 64-year-old woman and a 75-year-old man — were reported July 22. A total of 264 cases of infections have been reported statewide, and a total of 749 nationwide as a direct result of the outbreak.
Under the bill, compounding manufacturers would pay a registration fee to the FDA, which would be used to cover inspection costs. Revenue from the fees would allow the FDA to inspect all large-scale compounding manufacturers in about three years, according to the Senate HELP committee.
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