Nomination of Robert Califf
Floor Speech
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Mr. MARKEY. Madam President, today we are about to begin consideration of the nomination of Dr. Robert Califf to lead the Food and Drug Administration. This is a historic time at that agency. It has a record which is not enviable in terms of the way in which it has been dealing with the opioid prescription drug epidemic in our country.
I want to give just a very brief history of what has been happening on that issue. About 20 years ago, the FDA was asked to approve OxyContin--which is just a shortened form of oxycodone--continuously going into the bloodstreams of Americans. Purdue Pharma represented that this would be a safer way of having prescription opioids go into the American medical system. Nothing could have been further from the truth because oxycodone--the material inside of OxyContin--is molecularly very similar to heroin.
So when one has a bottle of OxyContin or oxycodone continuously in your cabinet--30 pills, 60 pills or more--you are talking about having a bottle in your medicine cabinet that is very close to being heroin. Now if someone said to you that your child or family member is now taking something that is very close to heroin, that would have a profound impact on you--but that is never quite explained to the American public. That is something that was not understood at the time because Purdue Pharmaceutical company was representing that it was safe to take OxyContin. It turned out that was not the case.
Today we have an epidemic in the United States. More than 30,000 people in 2014 died from this prescription drug heroin epidemic which is ravaging our country. This is a dramatic increase from 1996, when we really didn't even talk about it in our country. More than 30,000 people died in 2014. The number most likely was much higher last year. The number, most likely, will be even higher this year as well. Here is the story--80 percent of all people who are dying in the United States from heroin overdoses started on prescription opioids. Eighty percent of all people who died in 2014 from heroin overdoses started on prescription opioid painkillers. So the pathway into this heroin epidemic is quite clear. It is the Food and Drug Administration approving these new prescription opioid pills without the proper safeguards having been put in place to ensure that it doesn't make the problem worse rather than improving the problem.
That is why the debate on Dr. Robert Califf is so important. The Food and Drug Administration is saying they will not empanel expert advisory panels to review the approval of each one of the new prescription opiates that are in the pipeline right now at the FDA. What is the evidence that will cause big problems? Well, back in 2012 the FDA had to consider Zohydro. Zohydro was a new prescription pain opioid. They empaneled a group of advisers--experts--to look at the drug. By 11 to 2, the expert advisory panel said: No, do not approve this new drug, unless we establish a whole new system or standard in America for addiction, abuse, for diversion of these drugs. Don't do it. The FDA ignored the advisory panel and approved Zohydro, with experts all across America attacking the FDA for not understanding how fundamentally the culture in our country had changed since 1996 with the first approval of OxyContin.
Moving forward, the FDA decided it would not empanel expert advisory panels at all because they knew most likely they would vote no. So on new drugs such as Hysingla or Targiniq, there were no advisory panels at all because it was said by those companies that there are abuse deterrents that are inside those new opioids.
What does that mean? Abuse deterrent is basically going to the issue of whether that new pill--that new drug--can be crushed to be used for purposes other than what is intended, which is to be a painkiller. However, if the individual just continues to take the pills in the bottle as they are prescribed and they do it on a continuous basis, they run a high risk of becoming addicted.
The warning went out from all of these outside groups that expert advisory panels were needed. The FDA ignored them. Then we hit August of 2015. Believe it or not, Purdue Pharma wanted to get approval for 11- to 16-year-olds to have OxyContin. Remember, this is heroin equivalent. This would go to 11- to 16-year-olds. What they decided to do was to not have any advisory panel at all on that issue in August of 2015. This is despite the fact that it was controversial, that it had tremendous social impact on our society, and that the FDA's own guidance says that expert advisory panels are needed on drugs of that nature when pediatric dosing or child prescribing is in question. The FDA just ignored it.
I put my hold on Dr. Califf's nomination. Senator Manchin put his hold. We are raising this issue. We are saying to the FDA that we need advisory panels. We need a change of culture at the FDA. This just cannot continue.
The FDA said they would look at it. The FDA said they would study it. Then the FDA announced 2 weeks ago that there would be no advisory panels for any of the new opioids which are in the pipeline over at the FDA because they are ``abuse deterrent.'' Abuse deterrent is an oxymoron. It is a contradiction in terms. It is like jumbo shrimp. There is no such thing as an abuse deterrent inside of a bottle of pills that have the same molecular constitution as heroin, especially if we are talking about giving it to kids age 11 to 16 in our society.
By the way, if you want to know why there has been a spike in the number of breaking-and-entering crimes in people's homes, with people breaking in and looking for these bottles of pills, I will tell you why. Each one of these pills can be worth upward of $80 apiece on the streets of America. Hear that number? For a bottle of 60 with 80 milligrams is worth between $4,000 and $5,000 on the streets of America. That is why they want to break into your house. They don't take the TV. They are looking for that bottle of medicine because that is how much it is worth. That is how much they can sell it for.
When do we begin to get real about the fact that it is a bottle of heroin-equivalent in people's homes?
Ultimately, when all their prescriptions are finished off and they can't get it anymore from the doctor, they wind up with heroin at $5 a bag in the street. So America, it doesn't matter which community in America we are talking about. It can be Boston, West Virginia, Kentucky, California, it is all the same story, the same pathway in, for 80 percent of all those who overdose on heroin in our society. They are still looking for that heroin-like experience.
So we have a big issue that the FDA is not responding to, which is why I don't believe Dr. Califf should be confirmed until we have a change at the FDA, and they are not going to do it. We have to make sure they understand it is a coalition of pharmaceutical companies and physicians which have created this epidemic in our country. We are reaching a point where we are going to have a Vietnam war equivalent of people dying every single year inside of the United States on an issue created largely by the pharmaceutical and physician community in our society. So when do we start getting real about it? When do we start having a reality check, that while we are 5 percent of the world's population here in the United States, we consume 80 percent of all of the prescription painkillers in the world? Mix well, wait 20 years, and a pandemic has broken out across our country.
The FDA has a responsibility to ensure that we put the protections in place, that the warnings are there, that the dosage is correct, and that the preventive measures are used to reduce dramatically the number of families who are going to be devastated by this issue.
When people have back pains, when people have issues other than the most life threatening, we have to begin to discuss how long we want these people to be on something that has the same molecular constitution as heroin. It is a big issue. Lower back pain, broken legs--there is perhaps a greater danger from the prescribing than there is from the actual underlying injury in terms of the long-term consequences for these families.
We have to have this discussion in our country. We have to have the kind of discussion that says that heroin overdoses in our country have quadrupled in the last 14 years--quadrupled--and 80 percent of it started with prescription opioids. We have to have this discussion.
Dr. Califf has been nominated as the new head of the FDA. They are not going to change business as usual at the FDA. They are not going to do it. They have already announced it. They don't want to hear from experts. Their slogan at the FDA is no experts need apply to come in and give advice to the pharmaceutical companies and to the FDA. No warnings are needed from anyone with regard to what this industry has been doing to our country and what the FDA has been approving. So this issue is one that absolutely is at the top of the list of the things we have to deal with in our country.
Last year, the Food and Drug Administration, the agency that actually approves how much of this opioid painkiller can be sold in--and the way the system works is individual companies go to the Food and Drug Administration, tell them how much they want to have approved, and then the FDA never tells the rest of the world how much they allowed each company to, in fact, manufacture in terms of the painkiller, the opioid. They give an aggregate number, but they never tell you how much each company got approved.
What I would like people to do in their minds right now is to think for a moment how many prescription opioid pain pills--equivalent in oxycodone, other opioids--were approved by the Food and Drug Administration last year. Just pick a number. How many pills total? Do you have a number in your head? I am going to give you the answer: 14 billion. Can I repeat that? There were 14 billion prescription opioid pills approved for a country of 300 million. That is a bottle for every single adult--a bottle, again I tell you--with the material that has the molecular equivalency of heroin inside the cabinets of people inside the United States of America.
This has to stop. It has to end. I understand it is a good business model for the companies manufacturing these things, but it is not good for America, and it is not good for the families in our country. The FDA has to stop them. That is why Senator Manchin, Senator Blumenthal, and others who are going to be speaking on this issue--we don't think Dr. Califf should be approved until they change business as usual, until they make a commitment that they are going to change business as usual at the Food and Drug Administration. They are supposed to be the guardian of our public health. They are supposed to be the arbiters of what is safe for Americans to consume, but they have not been doing the job. I am not talking about 1996 anymore; I am talking about 2015 and 2016. I am talking about right now with the evidence of this national tragedy manifesting itself in every community in our country.
The least that the Senate should be able to say is that it tried, really tried, to deal with this issue that has been created by the pharmaceutical and the physician community. It will not be enough to say that we are going to authorize $1.1 billion for treatment, although we need treatment because there are millions of people who are going to need it in our society.
We have to go back to the root causes of this problem, this flood of drugs that have gone into this society, the lack of prescribing education that physicians have to undergo. The FDA indicates that only 10 percent of physicians in America voluntarily even get educated with regard to what are the consequences of having a bottle of molecularly similar heroin pills to be put inside the cabinets of Americans--10 percent of physicians. That is just plain wrong, ladies and gentlemen. We have to make sure that the education is there for the physicians who need it. We have to make sure that the pharmaceutical companies do not get permission to be able to get these new pills approved until there is a new standard for abuse, a new standard for addiction, a new standard for the diversion of these pills, a new standard for what abuse deterrent means because right now, again, it is a contradiction in terms.
You can still get addicted by taking an Oxy or a Percocet over and over again, day by day. You are going to get just as addicted. It is not an abuse deterrent if that is how you are going to be taking it. You still wind up with the same problem.
We need to get real here. There is no bigger issue in our country. There is no more profound change that has taken place on the streets of our country. When it increases by fourfold in just 14 years, what is on the horizon for our society if we don't put an end to it?
Working with other Senators, I intend to continue to explain this problem to other Members. I could not have a better partner than the Senator from Connecticut, Senator Blumenthal, who as attorney general in the State of Connecticut and now as a Senator has focused laserlike on this issue. We are both committed to making sure that education of physicians becomes an indispensable part of the remedy--the Rx that we in the Senate put on the books--so that at a minimum that education is made mandatory for every physician who is going to be handing out these pills to otherwise unsuspecting Americans.
I will just finish this way. One patient came up to me and said: You know, when a doctor says to you that these pills for your family member are good, you are not going to second-guess the physician. You are going to assume that because the physician gave them to you, they must be good.
And then this man said to me that he and his wife looked back and said: Should we have known more? Should we have done something different? Should we have tried to protect that other family member?
No, it should be the FDA. It should be the DEA. It should be the physicians. It should be the prescribers. They are the ones that should have the responsibility, not the guilt that they are giving to families all across the country that they should have known more. No, ladies and gentlemen, this is the time for us to finally act on this issue.
I yield to the great Senator from the State of Connecticut, Senator Blumenthal.
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Mr. MARKEY. I thank the Senator from Connecticut, and we intend on continuing this battle right through this entire confirmation process and beyond. Unless we stop it now, FDA is not going to stand for ``Food and Drug Administration,'' it is going to stand for ``fostering drug addiction.'' That is what it has been doing. It has to change the way it does business. It has to respond to this addiction and abuse crisis in our country. It has to be the cop on the beat. It has to understand its responsibility to not allow this flood of drugs to go into our society, and we have to begin the battle now.
I urge all Members to vote no on this nomination. This is not directed personally at Dr. Califf but directed at an agency which has allowed this flood of drugs into our society without putting the proper protections in place.
I now yield to the great Senator from West Virginia, who has dedicated his career as Governor and as Senator to leading on this issue.
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