LANSING, Mich. (AP) — State oversight of compounding pharmacies would increase under legislation that unanimously passed the Michigan Senate on Tuesday following a fatal 2012 meningitis outbreak.
The two Senate bills would raise licensing, record-keeping and inspection standards for pharmacies and would designate compounding pharmacy violations as felonies.
The legislation responds to a 2012 meningitis outbreak linked to the New England Compounding Center that sickened about 750 people in 20 states and caused 64 deaths, including 22 deaths in Michigan patients and more than 260 reported cases of illness. The Framingham, Massachusetts-based company allegedly distributed tainted steroid injections to patients.
The bills would require pharmacies, manufacturers and distributors to designate a pharmacist in charge. Certain applicants would need to undergo criminal history checks, and the state would have greater power to suspend licenses. The bills now go to the House.
Bill sponsor Sen. Joe Hune, R-Whitmore Lake, said the legislation will help prevent similar incidents in the future by increasing accountability.
Hune said he is “usually the first to critique” increased government regulations, but this legislation is an exception due to potential dangers to Michigan residents.
“This is a case where government has to be in the middle of it in terms of oversight and some robust regulation,” he said. “Because look at it. We have friends of my family that were afflicted with this and it’s awful. Our community was really afflicted with it.”
Hune represents Livingston county, where the tainted steroids were distributed, as well as in Genesee, Macomb and Grand Traverse counties.
The Michigan Pharmacists Association and the Michigan Association of Health Plans supported the bills, while CVS Caremark opposed them in Senate committee. The Associated Press left a message with CVS Caremark Tuesday.
NECC agreed last week to a $100 million settlement to compensate victims, which a judge must approve. The company surrendered its license after the 2012 outbreak, which hit Michigan, Tennessee and Indiana the hardest, and later filed for bankruptcy.
The money would be distributed among families of those who died, those who sustained serious injuries after being injected with the steroid and other creditors. The victims developed fungal meningitis, an inflammation of the lining of the brain and spinal cord, or other infections.
No criminal charges have been lodged in the case, but a state criminal investigation led by Attorney General Bill Schuette is ongoing. The company’s owners have denied wrongdoing or liability.