[Congressional Record (Bound Edition), Volume 159 (2013), Part 12]
[Senate]
[Pages 17228-17229]
[From the U.S. Government Publishing Office, www.gpo.gov]




                     DRUG QUALITY AND SECURITY ACT

  Mr. ALEXANDER. Mr. President, 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 
Commissioner 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. Four 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.

[[Page 17229]]

  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 1 
year on the compounding pharmacy bill and more than 2 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.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Arizona.
  Mr. McCAIN. While the Senator is on the floor, I wish to thank my 
colleague from Tennessee for this legislation and the hard work he has 
done on it. Also, there was significant pain and difficulties 
experienced by his constituents in Tennessee. This is something that I 
think will benefit all Americans and a rare bipartisan occasion in the 
Senate, which we should all celebrate. I thank my colleague from 
Tennessee.

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