Op-ed by Sen. Alexander in The Tennessean: "Bill Will Clarify Oversight of Compounders"

Last year’s fungal meningitis outbreak was a nightmare for Tennesseans. Our state alone suffered 152 cases, including 15 deaths.

The tragedy would have been much worse if not for the heroism of state officials with the Department of Health who discovered the problem and helped to identify the cause. Their work prevented more people from getting sick and saved countless lives.

Last week, the Senate’s health committee completed work on legislation I sponsored to try to make sure this never happens again. The next step is consideration by the full Senate.

I believe most of the problem with the meningitis outbreak was a lack of clear accountability for regulating the large Massachusetts pharmacy that compounded (or mixed) the tainted drugs. There was confusion between the U.S. Food and Drug Administration (FDA) and the Massachusetts pharmacy board over who was responsible for overseeing businesses that functioned in between a traditional corner drug store and a drug manufacturer.

The primary goal of our legislation is to erase that confusion. My experience as governor was that whenever I gave a job to more than one person, it often came back not done. But when I put one person “on the flagpole” and in charge, it was surprising to see how assigning responsibility got it done.

Adm. Hyman Rickover, the father of the nuclear Navy, told his submarine captains that if anything went wrong with the ship’s reactor, the captain’s career was over. As a result, there never has been a death from a problem with a Navy submarine reactor.

This legislation will create that kind of accountability in compounding regulation. I do not intend to sit through another hearing where the FDA can point its finger at someone else instead of taking responsibility for its failure to regulate and enforce large-scale compounding, or claim it didn’t have clear enough authority.

The legislation our committee recommended gives clear guidance, so that when you walk into a pharmacy or manufacturing facility, you know exactly who’s in charge of regulating that facility — there will be no confusion about who is in charge of keeping those products safe.

To do this, we identified three categories for businesses, and made it clear who regulates each one. One category is for the traditional drug manufacturer. The FDA would continue to regulate these businesses.

The second is a new category we are identifying and calling “compounding manufacturers.” These are the businesses that make sterile products in advance of a prescription and sell them across state lines. These compounding manufacturers fill a need when the products made by drug manufacturers need to be tailored or combined for certain hospital patients. Hospitals increasingly turn to compounding manufacturers to make those changes to the drugs. This new category of compounding manufacturers will be regulated by the FDA.

The third category is the traditional pharmacy or corner drugstore. States will continue to oversee and regulate these businesses. Putting one agency on the flagpole for each of these businesses will mean greater safety for consumers.

We have been fortunate enough to live in a country where we can walk into one of 60,000 drugstores or pharmacies, or visit a doctor or a pain clinic, and not question the safety of the medicine we receive. Last year’s meningitis outbreak has shaken that confidence, and those of us who have worked on this legislation believe making clear who’s in charge of regulating each of these manufacturers and pharmacies will begin a path to restoring it.

Lamar Alexander is Tennessee’s senior U.S. senator.



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