New legislation announced Thursday would more closely regulate 470 compounding pharmacies in Michigan a year after the state became the epicenter of a deadly meningitis outbreak linked to contaminated steroids.
Though the deaths were blamed on a Massachusetts company outside the reach of Michigan regulations, state authorities said a review indicated more should be done to strengthen oversight of state compounding pharmacies.
“We owe it to the victims of this tragedy to ensure something of this magnitude does not happen again,” Attorney General Bill Schuette said in a news conference at his Lansing office, where he was joined by Department of Licensing and Regulatory Affairs Director Steve Arwood and Sen. Joe Hune, who will sponsor the measure.
The bill to be introduced would require compounding pharmacies and manufacturers to undergo an inspection at least once during each two-year licensing cycle. They are not routinely inspected now.
Compounding pharmacies would have to keep detailed records of their products, and all pharmacies would be required to designate a licensed “pharmacist-in-charge” on site who is responsible for following state laws and rules. Pharmacy owners would need criminal background checks.
“If there is an issue, a known risk out there, this gives us the ability to immediately respond to that, get the detailed information and track it back very quickly,” Arwood said.
Compounding pharmacies mix customized injections, creams and other medications in formulas specified by doctors. They have long operated in a legal gray area between state and federal regulations.
The industry came under scrutiny after a 2012 fungal meningitis outbreak traced to tainted steroids produced at the now-shuttered New England Compounding Pharmacy in Framingham, Mass., killed 64 people and sickened nearly 700 others. The steroids were shipped to four Michigan clinics. Patients who became ill had received injections for neck or back pain.
Hune, a Republican from Livingston County’s Hamburg Township, represents a district that was hit hard because one of the clinics is in Brighton. He said one of his constituents — a family friend — was sickened by injections after getting shoulder surgery, had to miss 11 1/2 months of work and suffered extreme hallucinations, but was one of the lucky ones because he lived.
“The long-term ramifications and impact to his life has yet to be gauged,” Hune said.
At Schuette’s request, a multi-county grand jury investigation of the outbreak was authorized in April and is ongoing.
The Republican attorney general’s announcement of legislation drew criticism from Mark Totten, a Democrat hoping to face him in next year’s election. He said Schuette, as a state senator in 1995, voted to shield pharmaceutical makers from product liability lawsuits.
Michigan victims of the tainted steroids can still sue because the federal Food and Drug Administration did not regulate the steroids.
“We must take every step to prevent a similar tragedy from ever happening again here in Michigan,” Totten said in a statement. “But if Bill Schuette was serious about protecting Michigan citizens from medicines that harm or kill, he would immediately call for legislation repealing his outrageous drug immunity law he championed and passed as a state senator. Schuette’s drug immunity law has left thousands of victims here in Michigan helpless, while losing millions of dollars for Michigan taxpayers.”
http://www.macombdaily.com/20130919/tighter-pharmacy-rules-planned-after-michigan-deaths
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