On Monday, the U.S. Senate passed my legislation to help prevent another meningitis outbreak like the one last year that killed 16 Tennesseans and sickened so many others. Tennesseans deserve this legislation, which will soon become law and make clear exactly who is on the flagpole for overseeing the sorts of facilities that led to last year’s outbreak.
When the Health, Education, Labor and Pensions Committee – of which I am the lead Republican – held its first hearings on this tragic outbreak last November, we looked at how could this possibly happen. The compounding facility in Massachusetts that produced these contaminated drugs operated more like a manufacturer, but it was unclear if the state or the FDA was in charge.
I made it clear from the first Senate hearing that my priority was to find a way to clarify who is accountable – who is on the flagpole – for overseeing the safety of drugs made in these large-scale drug compounding facilities.
The legislation that is set to become law is the result of an agreement I helped reach between the Senate and House health committees to make it clear exactly who is in charge of overseeing each compounding facility. The U.S. House of Representatives passed it on Sept. 28.
It distinguishes compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions.
It also creates a new, voluntary third category called an “outsourcing facility.” If a drugstore chooses to be in this category, they follow one nationwide quality standard, and the FDA is responsible for all the drugs made in that facility. FDA is on the flagpole. Those who choose to remain traditional pharmacies will continue to be primarily regulated by the state, as they are in current law.
During this process, we heard stories like that of Diana Reed of Tennessee.
Diana was healthy – either ran or swam every day – and was the arms, legs and voice to her husband, Wayne, who suffers from Lou Gehrig’s disease. Diana began receiving injections for neck pain and found herself diagnosed with meningitis from these injections. Only a few weeks later, 1,000 people packed Otter Creek Church in Brentwood for her funeral.
FDA Commissioner Margaret Hamburg told us that if Congress failed to act, a crisis like meningitis outbreak was “a matter of when, not if.”
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, they won’t be able to.
The bill we are sending to the president’s desk affects the health and safety of every American, and I am pleased we have come to a consensus that takes a large step forward that they deserve.