Speeches & Floor Statements
Posted on November 12, 2013
On behalf of the people of Tennessee, whom I represent, and the American people, as well, I wish to thank the senator from Iowa for his leadership on these two bills, but particularly on the compounding pharmacy bill.
Our differences of opinion in the Senate are well advertised on Obamacare, on debt, on Syria, and on a whole variety of matters. In fact, one would say the reason we exist is to debate the big issues that haven't been resolved somewhere else.
There is another aspect of the Senate that is rarely well advertised, and that is when we get a result. Sometimes the results take a long time, involve a lot of people, and are very difficult to reach, and that is the case with this bill. Had not Senator Harkin been patient, as well as aggressive at the same time, in working with Republicans and Democrats and with members of the House, we would not have reached this point today.
It is important to call the attention of the American people to this result, these two pieces of legislation. One makes it clear who is in charge, as Senator Harkin said, who is on the flagpole when it comes to making sure the sterile drugs that are injected into your back -- because a person has back pain -- are safe so that they don't end up with a horrible death from fungal meningitis. Who is responsible for preventing that?
The second bill is how are we going to make sure the 4 billion prescriptions we have every year in this country are safe, that they are not stolen, and that they do what they are supposed to do. How are we to make sure we can track them all the way from the manufacturer to the pharmacy who dispenses them?
We have been working on these bills for 2 years. Lest anyone think that because it was a voice vote in the House and because we are close to unanimous consent in the Senate that it was easy to do, it is not that easy to do. In fact, it is worth going through how this happened before I say just a word to add to what the senator said about the importance of bills.
The FDA became involved in the fungal meningitis issue in September of 2012, 1 year ago, after reports from Tennessee that fungal meningitis was tied to a sterile compounded drug. This hits home to many Americans because a great many Americans have been injected in their necks, their backs, or their feet with a drug that is supposed to be sterile. If it is not, it could have terrible consequences.
Immediately, Senator Harkin called a hearing. November 15, 1 year ago, we had our first hearing. Within 6 months we released draft legislation to address the compounding pharmacy issue. We then had a hearing on that legislation. Then we passed the legislation after a lot of comment, all in the open. Everyone had a chance to weigh in. We passed it unanimously.
This committee on which we serve, Health, Education, Labor and Pensions, probably reflects the widest span of ideological differences we have in the Senate. The Republicans can be very conservative and the Democrats can be very progressive or very liberal, so one would think it would be hard to get a unanimous agreement, but we did.
The House went to work and came up with their own version of the bill, taking our work into account. We then worked with them through the summer to reach an agreement on how to reconcile the two. The House passed it by a voice vote and sent it to us. Today we have a piece of legislation that has been hot-lined. That means that both sides have sent it around to every single office. All but one senator have agreed we can pass it by unanimous consent. The senator has that right, as I have that right, the senator from West Virginia, and the senator from Iowa has that right, and sometimes we exercise that right. Later this afternoon we will be having a cloture vote, a vote to move to this bill. That cloture vote is going to succeed. There will be a sufficient number of Republican votes and a sufficient number of Democratic votes to say we are ready to deal with this.
Why are we ready to deal with this? Because Commissioner Hamburg of the Food and Drug Administration told us at our hearing what would happen if we don't. She said:
“We have a collective opportunity and responsibility to help prevent further tragedies. If we fail to act, this type of incident will happen again. It is a matter of when, not if, I'm afraid. If we fail to act now, it will only be a matter of time until we're all back in this room asking why more people have died and what could have been done to prevent it.”
No one is saying this legislation is going to guarantee that there will never ever be a tragedy again, but it will help prevent future tragedies. It will take up the responsibility she challenged us to do. We have spent 1 year on it, so many people have been involved, and it is time we move to do it. My hope is that after the cloture vote tonight, very soon thereafter, after everyone has had a chance to speak and say what they have to say, that we can pass this by unanimous consent, send it to the president, and say to the American people that our differences are well advertised, but our results can be equally important. We can pass a piece of legislation which, when taken with the track-and-trace legislation which accompanies it, affects the health and safety of every single American, period. I know the people of Tennessee would welcome a prompt solution to this, and this is what I hope we have.
Senator Harkin, as he often does, spoke in very personal terms about this legislation. I want to tell one story from Tennessee so we know what we are talking about.
Diana Reed, 56, of Tennessee, had tried massage and acupuncture, but neither eased her neck pain. One of the potential causes for her pain was an injury sustained while helping her husband, who has Lou Gehrig's disease, in and out of the wheelchair. Diana Reed was healthy, either ran or swam every day, in addition to becoming Wayne's arms, legs, and voice, according to her brother, Bob.
She decided to try a series of epidural steroid injections for her neck problems before her health insurance ran out after losing her job at a nonprofit group. This decision ended her life on October 3 of last year. She began receiving injections August 21, with a total of three scheduled, one every 2 weeks. She felt pain and nausea for a full day after the first two injections. After the third she began having headaches.
September 23, she finally agreed to go to a doctor and was quickly diagnosed with meningitis. While she remained stable for a few days and was mostly concerned about her husband's well-being -- remember, he has Lou Gehrig's disease -- and getting home to him as soon as possible, she took a turn for the worse. Her speech began to slur, she had trouble seeing, and eventually she had a stroke. One day later she was in a coma.
1,000 people packed Otter Creek Church for her funeral, among them the alumni of a childcare learning center for inner-city preschoolers that she and her husband had founded. The autopsy found fungal meningitis at the injection site and in Mrs. Reed's brain.
Mr. Reed has a rare form of ALS that worsens more slowly, and his mind has not been affected. Diana Reed would help him get in and out of bed, the shower, and his wheelchair. She became more instrumental in his accounting business as his speech worsened. After her death, members of their church brought meals, did laundry, and the church accepted donations to hire help to assist Mr. Reed with his personal care.
This is only one story of the tragedy that the commissioner of the FDA says will happen again if we don't act. We believe this bill will help to prevent such a tragedy. Steroid injections last year were meant to ease the pain of hundreds of Americans, and for many Tennesseans, instead, it became their worst nightmare. These vials of compounded medicine were contaminated. Sixty-four Americans, including 16 from my state, died from the outbreak. It is a horrible way to die.
When the HELP Committee held its first hearings on this tragic outbreak in November of last year, we looked at how could this possibly happen. It became clear that these contaminated vials were produced in a facility that was nothing like a traditional pharmacy, a corner drugstore, if you will. It operated more like a manufacturer, but it was unclear which regulator was in charge. Was the state in charge or was the FDA in charge? I made it clear at the beginning of the hearing that my priority was to find a way to clarify who is accountable for large-scale drug compounding facilities, who is on the flagpole for overseeing the safety of drugs made in these facilities.
I used the example of Hyman Rickover and the nuclear Navy in the 1950s. Admiral Rickover was doing something new. He was doing something dangerous, potentially dangerous. He was putting reactors on submarines and ships, and no one knew quite how that was going to work. What did he do about it? Admiral Rickover hired the captain. He interviewed the captain and said: “First, you are responsible for your ship; and, second, you are responsible for the reactor. If there is ever a problem with the reactor, your career is over.”
The U.S. Navy has never had a death on a nuclear ship as a result of a reactor problem because everyone knew, after Admiral Rickover made those decisions, who was on the flagpole.
There should be no confusion, after this bill is passed and signed by the president, who is on the flagpole for a particular facility that makes sterile drugs. We should be able to walk into any one of our 60,000 drugstores, pharmacies, our doctors’ offices, or pain clinics, and not have to worry about whether the medicines we get there are safe. The bill we are voting on represents that year of work we talked about to find a solution.
Today we have drug manufacturers on the one hand and traditional pharmacies, the corner drugstore, on the other. This legislation creates a new, voluntary third category which we call 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.
What is the advantage of this? First, it eliminates the confusion, it eliminates the finger pointing. If, heaven forbid, this should happen again, it will be clear whose fault it was, who didn't do their job of regulating. Second, it provides an option available to doctors and hospitals who, if they wish, can choose to buy all their sterile drugs from a facility regulated by the FDA.
Outsourcing facilities are subject to regular FDA inspections. The New England compounding center that caused these problems was not inspected by the state or the FDA from 2006 to 2011. Outsourcing facilities must report the products made at the facility to the FDA. The New England center that caused the problems was making copies of commercially available drugs, which is illegal. Outsourcing facilities must report to FDA when things go wrong with a product. Currently, large-scale compounders don't have any required reporting to FDA if they know about a problem with a product.
Finally, outsourcing facilities, this new category, must clearly label their products so patients know it is compounded rather than FDA approved. Traditional pharmacy compounders will continue to be primarily regulated by the states, but for outsourcing facilities, the FDA is in charge.
During our discussions we heard a lot about drug shortages. The senator from Iowa and I worked especially to deal with that. We tried to address it where appropriate in this legislation. We know that compounded products aren't the answer to drug shortages. We don't want compounded products to be the backup solution to drug shortages; we want a better answer than that. We recognized the problem and tried to address it.
Because of heroic reactions of state officials with the Tennessee Department of Health, more people didn't become sick from the outbreak last fall.
I don't intend to sit through another hearing where FDA can point the finger at someone else instead of taking responsibility or claim it doesn't have enough authority, and if we pass this legislation, FDA won't be able to.
This legislation also establishes clear rules for outsourcing facilities and puts FDA on the flagpole for drugs made in those facilities.
I hope my colleagues will vote this afternoon to move to the bill, and then shortly after that we will be able to move to approve it, as the House did.
Just one other comment. The chairman, the senator from Iowa, and Senator Burr, Senator Bennett, and others have been working for at least 2 years on this form of legislation we call track and trace. It has been through vetting. I think everybody has had a chance to read it and to make a suggestion about it. There have been many changes and adjustments to make sure it works.
Here is the problem. In the United States today, we have about 4 billion prescriptions written every year. We don't have a uniform system to track and trace these drugs once they leave the manufacturer, which makes it easier for counterfeits and substandard products to enter the market and puts patients at risk. The laws governing the tracking of drugs haven't been updated since 1988. In the last 2 years alone there have been three cases of counterfeit Avastin -- a cancer drug being distributed in the United States to physicians and patients -- where the counterfeit did not contain any of the active ingredient.
We have seen an increase in drug theft. We have no way of knowing if and when these drugs are resold in the U.S. supply chain. In 2009 insulin stolen from a truck much earlier was sold by pharmacies, and the insulin was ineffective due to improper storage. Stealing drugs has turned into a big business, and without assurance that drugs are stored under certain conditions and handled correctly throughout the supply chain, the drugs may not work.
This legislation would set up a system over time -- 10 years -- where products that are stolen could be flagged as such, preventing distribution to patients. It represents a consensus on establishing a national system for all prescription drugs to have a specific serial number on the bottles. That means wholesalers, repackagers, and pharmacies will be able to check the serial number on the bottle with the manufacturer to see whether that number was assigned by the manufacturer. The serial number will not only help prove it is not counterfeit, but the information can also be used to determine whether anything else has been reported about that bottle, including whether the product was stolen.
This won't happen overnight. Creating a system that traces 4 billion prescriptions, made by over 80 manufacturers on over 3,600 manufacturing lines that are dispensed to patients through a variety of ways will take some time. But the path laid out for us over a number of years will ensure that the U.S. drug supply chain is secure and that consumers receive drugs that work.
I want to thank the senator from Iowa, as I have already, for his leadership on these two extraordinary pieces of legislation; Senator Burr and Senator Bennett on the track-and-trace legislation; and Senator Roberts and Senator Franken worked hard on compounding legislation.
Let me end where I began. The FDA commissioner challenged us. She said that if we don't act, this tragedy will happen again. We have an opportunity to act tonight. I hope we do. The families who were devastated by this tragedy because of contaminated sterile injections that caused fungal meningitis in many of our states, especially in Tennessee, expect us to act.
If we do, it will not be as well advertised as the differences of opinion we can have in the Senate, but it will demonstrate how, when we work together over a period of a couple of years, we can take a very big piece of complex legislation -- in fact, two -- that affects the health and safety of every American and come to a consensus that takes a large step forward.
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