Traverse City Record-Eagle

September 24, 2013

Editorial: Proposed pharmacy oversight just half the battle in Michigan


Traverse City Record-Eagle

---- — Nearly six months ago, as the toll from a deadly meningitis outbreak linked to contaminated steroids continued to rise in Michigan and the Grand Traverse Area, so did frustration that there was little state and local officials could do about it.

The steroids had come from a now-defunct “compounding” pharmacy in Framingham, Mass., that was largely out of the reach of local law enforcement. In all, the tainted medication killed 64 people and sickened nearly 700 others nationally. In Michigan, the hardest-hit state, 259 fungal infections, some leading to spinal meningitis, were reported, leading to multiple deaths, according to the most recent tallies by the Centers for Disease Control and Prevention. The death toll included an 80-year-old Traverse City man who was the 17th person from the state to die.

Now, new legislation would more closely regulate 470 compounding pharmacies in Michigan. Although the death were blamed on the New England Compounding Pharmacy, state officials said a review indicated more should be done to strengthen oversight of Michigan-based compounding pharmacies.

The bill 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 also 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.

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 new law would be only half the battle. In the 1990s the Michigan Legislature passed one the of the most anti-consumer laws in the nation when it voted to shield pharmaceutical makers from product liability lawsuits. It’s the only law of its kind in the nation, and it has to go.

For a time, it appeared that Michigan victims of the tainted steroids — including 50 or so people from across northern Michigan — would not be able to sue because of that outrageous law. But because the federal Food and Drug Administration did not regulate the steroids, such suits are still possible.

For many families affected by the bad steroids, a lawsuit was going to be their only recourse to recover medical and other costs. To prevent them from suing would have victimized them again.

This is good law that is long, long overdue. Now the Legislature has to take the next step and stop putting the drug industry ahead of state residents.