By LAMAR ALEXANDER
Last year’s fungal meningitis outbreak was a nightmare for Tennesseans. We had more than 150 cases and 15 deaths. We did see some real heroism by state officials with the Department of Health, who discovered the problem and worked to help identify the cause, prevent more people from getting sick, and save lives.
My primary goal in responding to this nightmare was to make clear who is “on the flagpole” – who is accountable – to help prevent this from ever happening again. I have worked to do just that as senior Republican of the Senate Health, Education, Labor and Pensions (HELP) Committee, with legislation I’ve drafted with a bipartisan group of senators. The committee held a hearing on the proposed legislation on May 9.
Part of the problem that allowed conditions leading to the outbreak was confusion between, and inaction by, the U.S. Food and Drug Administration (FDA) and the Massachusetts pharmacy board over who was supposed to be regulating those businesses that, going forward, will be known as “compounding manufacturers.” These are businesses that make sterile products, in advance of a prescription, and sell them across state lines, often to hospitals.
The solution is to determine who is “on the flagpole,” and the draft legislation I’ve developed with fellow members of the HELP committee will make it clear who’s in charge of each facility. When I was governor of Tennessee, we had a cabinet meeting in which we discussed a very important piece of legislation, and agreed to get to work on it. When we got back one week later, nothing had happened – so I put a single individual on the flagpole. We were all glad to help him, of course, but it was to his credit if it passed, and it was his fault if it failed. The legislation passed.
I’d like to see that kind of accountability on the meningitis issue. We worked with the FDA, state boards of pharmacy (including Tennessee’s), pharmacists, doctors, and hospitals to develop this draft legislation, and we discussed it this past week in the committee. The legislation identifies three categories: One for pharmacies, one for traditional drug manufacturers, and a new one for these “compounding manufacturers.” States would continue to oversee traditional pharmacies, and the FDA would continue to oversee traditional drug manufacturers.
But the FDA would also be responsible – on the flagpole – for compounding manufacturers. When these compounding manufacturers make sterile products without, or in advance of, a prescription and sell them across state lines, the FDA will be ensuring the safety of those products.
If our legislation becomes law, it will be clear that the FDA is responsible for these compounding manufacturers. The doctor will know that, the customer will know that, the patient will know that, and the FDA will know that.
And Tennesseans will be able to feel more confident that last year’s nightmare won’t happen again.