Speeches & Floor Statements
Posted on November 18, 2013
This afternoon the Senate passed and sent to the president legislation that Tennesseans and Americans will welcome because it deals with the terrifying fungal meningitis outbreak that occurred more than a year ago that killed 16 Tennesseans and made many others sick.
The problem at that time was sterile compounded drugs that turned out not to be sterile. So when they were injected into patients for back pain or neck pain, those tainted drugs caused fungal meningitis and caused a number of Tennesseans to die and many others to become sick. Had it not been for the heroic efforts of the Tennessee State Department of Public Health, many others across the country may have been injected with that tainted medicine and become sick.
This is a very important piece of legislation which senators and House members have been working on for a year. I am glad it passed. I am sure the president will sign it. In our state, we know how personal this was. There is the story of Diana Reed from Brentwood, TN, who was the caregiver for her husband, who has Lou Gehrig's disease. She had neck pain -- maybe because of helping him in and out of a wheelchair -- went to the doctor, and got an injection for her neck pain. The next thing she knew, she had fungal meningitis and she died. Still, her husband with Lou Gehrig's disease lives on.
That story has been told in many states. We have been told by the sommissioner of the Food and Drug Administration that if we do not act, it will happen again. If we do not act, Commissioner Hamburg said, the question is not if but when there will be another tragedy. We have acted. No one should believe we can guarantee such a tragedy will never happen again, but for two reasons, it is much less likely we will have another tragedy like fungal meningitis as the result of contaminated drugs.
No. 1, we have cleared up the question of accountability. After this happened, and it was discovered that the tainted drugs came from the Massachusetts compounding pharmacy, there was a lot of finger pointing back and forth between the FDA and the state board about who should have been regulating this pharmacy, because there were other trouble signs. This never should have happened and would not have happened if they had been either properly regulated either by the state or the federal agency, the FDA.
That often happens when there is not accountability, when it is not clear who is on the flagpole, as I like to say -- when it is not clear who is in charge. We have used the example of Admiral Hyman Rickover, who was a Navy officer. In the 1950s, when he was assigned the job of the nuclear Navy, he told his captains two things: No. 1, you are in charge of the ship; and, No. 2, you are in charge of the reactor. If anything goes wrong with the nuclear reactor, your career is over.
As a result of that level of clear accountability, since the 1950s there has never been a death as a result of a reactor accident on one of our nuclear ships. This legislation creates that kind of accountability for compounded drugs.
It preserves the traditional role of states to regulate drugstores. Compounding is something almost every drugstore does. We have 60,000 of those, and that is an important job to the states. Most states do an excellent job.
It preserves the role of the Food and Drug Administration for manufacturers, those who manufacture large amounts of drugs which are prepared without an individual prescription. But it creates a new sort of facility which we call outsourcing facility. This facility is regulated by the FDA.
Two things have happened. One is either the FDA or the state is in charge of a compounding pharmacy. It will be one or the other. The second is there is a new outsourcing facility. A doctor or a hospital in Virginia or Tennessee may choose to buy all of its sterile drugs, for example, from a compounding pharmacy that is regulated by the FDA. It doesn't have to, but it may choose to do that.
We believe many will choose to do that, particularly with the sterile drugs that are sent across state lines without a prescription. This legislation affects the health and safety of millions of Americans.
There was a second part this legislation that was passed this afternoon that is equally as important and in some ways more far-reaching. We call it track and trace. That is the shorthand name for it. 4 billion prescriptions are written every year. What this legislation does is attach a serial number to each drug that is manufactured and follows it all the way from the drug manufacturer to the individual pharmacy. Why is that important? It is important so that one will know, if given a prescribed drug, that it works, is not counterfeit, and that it is safe. It will take several years to implement this, but the drugs that make the 4 billion prescriptions will now be able to be tracked and traced from the manufacturer to the pharmacy.
Many of our disputes are well advertised around the Senate. In fact, one could argue that is what we are for -- the resolution of disputes. If there weren't a dispute, we probably wouldn't be here. We would work everything out at the city council, the governor's office or somewhere else.
The big issues of the day stand here. Some of those are hard to resolve. Obamacare is hard to resolve, fixing the debt is hard to resolve. We have very different points of view.
On this issue, which was difficult to do, we worked for more than one year on the compounding pharmacy bill and more than two years on the track-and-trace bill. It was very difficult to do. We were able to do it.
I commend Senator Harkin, who is chairman of our committee, Senator Franken, Senator Roberts, Senator Burr, Senator Bennet, and many other members of the committee. We were able to involve many people in it and come out with the unanimous recommendation of our committee, and it was unanimous today.
Just because it was unanimous, I don't want anyone to think it was easy. It was hard work. Because it was unanimous, I don't want anyone to think it is not important.
It is important in Tennessee to those 16 families who had a family member die. It is important to the dozens of families with a member of their family who is sick because of those injections. It is important to those families who may still become sick in our state and other states.
No. 1, it is important to know after this who is on the flagpole. It is either the FDA or the state agencies, and there will be no more finger pointing.
No. 2, any doctor or hospital that chooses to buy its sterile compounded drugs that are shipped interstate in large amounts without prescription from an FDA-related facility may do that.
This is a day of results in the Senate, which I am pleased to see.
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