A new model for oversight in wake of meningitis outbreak

By SEN. LAMAR ALEXANDER
On November 15th, I participated in a Senate committee hearing on the deadly meningitis outbreak that has become a nightmare for Tennesseans.  It has claimed the lives of 13 Tennesseans, made 81 ill—very ill in many cases — and left a thousand others worrying if they might become ill.
This outbreak was caused by contaminated epidural steroids from the New England Compounding Center, based in Massachusetts.
At the hearing, held by the Senate Health, Education, Labor and Pensions Committee, of which I am a member, it became obvious that something, incredibly, slipped through the cracks. 
We have more than 60,000 drugstores and pharmacies in the country.  Many of them are doing pharmaceutical compounding.  You go in and get a prescription filled, and it might call for an adjustment to the medicine.  For example, compounding is necessary if a patient is allergic to a preservative in an approved drug, or when a child needs a lower dosage if there is not an existing version of the drug made for children. That is normal and necessary.
While compounding pharmacies are regulated by state boards of pharmacy and manufacturers of drugs are regulated by the Food and Drug Administration, there are entities taking advantage of a murky area between the two. For example, the company in Massachusetts was a manufacturer masquerading as a compounding pharmacy.
Fortunately, we saw a textbook model of what ought to be done by the Tennessee Department of Health and the Centers for Disease Control in response to this tragic outbreak.   Had it not been for remarkable work by the Tennessee Public Health Department in conjunction with Vanderbilt University and the Centers for Disease Control, there could have been many more deaths and many more injuries.  
My experience as governor was that whenever I gave a job to more than one person, sometimes it came back not done. But when I put one person on the flagpole, it was surprising to see how assigning responsibility got it done.
It seems to me that one guiding principle of working this out is: Let’s stop this dual responsibility. We need a new model of oversight of sterile compounding pharmacies that would give one agency full accountability and responsibility.
I am working with the committee members on legislation,and I hope to begin the new year with a bipartisan bill that will put somebody on the flagpole for this.  It is critical that when we go to the hospital or go to the pharmacy or outpatient clinic that we not worry about whether the medicines we are receiving are tainted or unsafe.   Published in The WCP 11.29.12

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