Posted on November 17, 2013
The Senate this week will vote to pass and send to the president’s desk a bill to help prevent future tragedies like the meningitis outbreak that has caused 16 deaths and so much pain in Tennessee.
This bill is the result of an agreement I helped the Senate and House reach to clarify who is in charge – who is on the flagpole – for ensuring the safety of sterile compounded drugs like the steroid injections that last year were meant to ease pain but that instead became a nightmare for so many.
Take the story of Diana Reed, who, caring for her husband who suffers from Lou Gehrig's disease, was herself suffering with neck pain. She tried a series of epidural steroid injections, and found herself diagnosed with meningitis from the injections. Only a few weeks later, a thousand people packed Otter Creek Church in Brentwood for her funeral.
Fungal meningitis is a horrible way to die. Diana’s is only one story, and it’s one story too many.
FDA Commissioner Margaret Hamburg told us last year that if Congress failed to act, a crisis like the meningitis outbreak was “a matter of when, not if.”
Shortly after the outbreak, I called for a new model of oversight of sterile compounding pharmacies, because it was clear that the Massachusetts facility responsible for the contaminated drugs fell into a regulatory grey area in which it wasn’t clear whether the state or FDA was in charge. Americans should be able to walk into any one of our 60,000 drugstores or pharmacies, doctors’ offices or pain clinics, and not have to worry about whether the medicines we get there are safe.
Once this bill is signed into law, there will be no confusion over who is in charge of overseeing a particular facility that makes sterile drugs.
Today we have drug manufacturers on the one hand and traditional pharmacies—corner drugstores—on the other. This legislation creates a third category we call an “outsourcing facility.” If a compounder chooses to be in this category, it follows one nationwide quality standard, to be overseen by the FDA. For those that choose to remain traditional pharmacies, the states are on the flagpole.
This eliminates the confusion and finger-pointing at the root of last year’s outbreak. My guiding principle on this was that of accountability, best demonstrated by Admiral Hyman Rickover, the father of our nuclear navy. He told captains of nuclear submarines that they were responsible for the nuclear reactors on their ships – and that if anything went wrong with the reactor, their careers would be over. The message was clear – and we haven’t had a single death on a nuclear submarine as a result of a reactor.
The legislation allows doctors and hospitals to choose to buy all their sterile drugs from a facility regulated by the FDA.
I don't intend to sit through another hearing in which the FDA can point the finger at someone else instead of taking responsibility, or claim it didn't have enough authority – and once this bill becomes law, the FDA won't be able to.
It is not easy these days to pass laws, but the overwhelming support in both houses for this bill, which the president is expected to sign shortly, shows how big this problem could become for every single American – and how important this solution is to do all we can to reduce the likelihood that an outbreak like this never happens again.
Lamar Alexander is Tennessee’s senior U.S. senator.