[Congressional Record Volume 162, Number 27 (Monday, February 22, 2016)]
[Senate]
[Pages S899-S907]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                      NOMINATION OF ROBERT CALIFF

  Mr. McCONNELL. Mr. President, drug overdose deaths, driven largely by 
prescription painkillers, continue to outpace the number of fatalities 
from traffic accidents in Kentucky. While I recognize the need to 
protect legitimate patient access to prescription painkillers, the FDA 
must do more to help us fight back in the midst of today's 
prescription-opioid epidemic.
  The FDA plays a leading role in addressing this epidemic through its 
drug approval process, in which it is required by Federal law to ensure 
the safety and effectiveness of all drugs. However, the FDA has been 
rightly criticized for not recognizing the severity of this significant 
problem and for not taking greater action to address it.
  Over the years, I have heard from many Kentuckians concerned about 
FDA's lax attitude in this area, with many of the belief that the 
agency simply has not taken its role in fighting the prescription 
opioid epidemic seriously.
  To try and push the FDA in the right direction, I contacted the 
agency in both 2012 and 2013 to warn of the problems with allowing 
generic, crushable opioids to be made available without the 
introduction of abuse-deterrent features. As a result, the FDA 
announced in April 2013 that it had decided to prohibit a generic 
version of a certain opioid that lacked abuse-deterrent features.
  I also cosponsored a measure in the last Congress that aimed to push 
the FDA to encourage the development and use of abuse-deterrent 
formulations of prescription opioids, which make them harder to crush 
and abuse.
  Additionally, I joined more than 20 Senate and House Members last 
October in a letter to OMB's Administrator of Information and 
Regulatory Affairs, Howard Shelanski. We urged him to help us tackle 
the prescription-drug abuse epidemic by taking down barriers in the 
Medicaid repayment system that actually discourage manufacturers from 
developing the very same abuse-deterrent formulations that I have been 
pushing the FDA to encourage.
  I recently met with Dr. Robert Califf, the FDA Commissioner nominee 
we will consider this evening. We had a productive meeting in which I 
expressed my concerns about the agency's past insensitivity to the 
opioid crisis, along with my desire to see the FDA play a more 
prominent role in addressing this prescription-opioid epidemic.
  Dr. Califf shared his proposed plan to reassess the agency's approach 
to approving and regulating prescription painkillers. Dr. Califf also 
acknowledged that a cultural shift will be needed within the FDA if the 
potential for addiction and abuse of prescription opioids is to be 
taken more seriously. He assured me that, as head of this important 
agency, he would be the kind of leader our country needs when it comes 
to confronting this growing epidemic.
  I believe Dr. Califf understands the dire nature of the opioid 
epidemic, and accordingly, I believe he is today the right person to 
lead the FDA in a new direction. That said, confirming Dr. Califf will 
be just the beginning of a much longer and enduring effort on 
everyone's part; he and the FDA should expect continued rigorous 
oversight in the way the agency deals with prescription opioids moving 
forward.
  Mr. LEAHY. Mr. President, today the Senate will consider the 
nomination of Dr. Robert Califf to head the Food and Drug 
Administration. For too long, the FDA has been without a Senate-
confirmed commissioner, and, given the scope and reach of the agency, 
action on Dr. Califf's nomination is welcomed. After speaking with him 
and carefully reviewing his record, I have decided to support this 
nomination.
  Consumers depend on the FDA to ensure that food, medicine, and 
products sold in this country are safe. The agency has oversight of 
one-quarter of all consumer goods sold in the United States, including 
nearly $1 trillion in foods, drugs, medical devices, cosmetics, and 
supplements. The Commissioner must supervise this critical work with 
independence from outside influence. Some Senators have raised concerns 
about Dr. Califf's record as a researcher who worked closely with drug 
companies and have questioned his ability to make decisions free from 
the influence of the multibillion dollar pharmaceutical industry. After 
speaking with Dr. Califf and reviewing his record, I believe that he 
will conduct himself with integrity and in the best interest of the 
public.
  While the head of the FDA must be an independent voice, we should not 
discount the benefits having a Senate-confirmed Commissioner who 
understands the importance of medical research and the potential to 
advance lifesaving treatments. Under Dr. Califf's leadership, the Duke 
Clinical Research Institute made advances in drugs that dissolve blood 
clots, cut the risk of heart attacks and strokes, and lower 
cholesterol. As director of the Duke Translational Medicine Institute, 
Dr. Califf worked closely with the National Institutes of Health, the 
FDA, and the Institute of Medicine to help ensure scientific 
discoveries are translated into usable treatments. I believe that Dr. 
Califf's understanding of the importance of research in promoting 
lifesaving treatments and his ability to navigate potential conflicts 
that can arise with drug-industry funded research will be an asset to 
him as the leader of the FDA.
  Dr. Califf and I also discussed other issues of importance before the 
FDA, including the labeling of generic drugs. For several years, I have 
led a group of nearly 40 Democrats in Congress in pressing the FDA to 
require generic drug manufacturers to update their safety labeling, 
instead of simply mirroring the brand companies' warnings, as they do 
now. Generics fill over 80 percent of prescriptions, but injured 
patients have no remedy against them if their product is mislabeled. 
Patients who are injured by a brand-name drug can seek justice, but 
they have no remedy if, like countless Americans, the drug that injures 
them is a generic. All drug manufacturers should be required to improve 
the warning information they give to doctors and consumers. Americans 
have waited 3 years for the FDA to finalize their rule regarding the 
labeling of generics, and I intend to continue to urge the FDA, and Dr. 
Califf if he is confirmed, to move forward on this critical issue.
  The next Commissioner of the FDA must also work to promote safer 
alternatives to powerful prescription painkillers and to remove from 
the market older, less safe drugs. Dr. Califf and I discussed the FDA's 
recent announcement to expand access to abuse-deterrent formulations of 
these powerful

[[Page S900]]

drugs to help address the opioid epidemic in this country. While it is 
a step in the right direction, the FDA can and must do more. I 
appreciate Dr. Califf's commitment to redouble the agency's efforts in 
combatting this issue, while working closely with other governmental 
agencies that can oversee the prescribing of these drugs. I expect to 
work closely with the agency on this issue and will continue to press 
Dr. Califf to take action in this area.
  I hope that the FDA will also recognize the significant concerns that 
I and others in Vermont and other maple producing States have for the 
harm being done to maple sugar producers' income as a result of 
potentially false and misleading labeling of products that contain 
neither maple syrup nor real maple flavor. I recently meet with 
sugarmakers in Vermont who are asking for a strong and thorough 
investigation into possibly misrepresentative labeling of food products 
whose labels incorrectly indicate the presence of maple syrup and 
request appropriate enforcement action where warranted. The tradition 
of sugaring is significant not only to our cultural heritage in Vermont 
and throughout New England, but to our efforts to strengthen the 
working landscape and local agriculture in rural parts of our States.
  Vermont's cheese industry, particularly raw milk cheese producers, 
have also raised concerns about FDA overreach. While I fully support 
the FDA's efforts to ensure the safety of our Nations' food supply, I 
believe that standards set by the FDA must be scientifically based and 
must address a known threat to public health. There have been some 
positive steps forward, and the FDA has recently met with these 
producers, agreeing to hand over the FDA's data on the standards they 
had set. I hope that progress continues, and I look forward to hearing 
how these discussions and data sharing is going.
  We know that food safety will also be high on the priority list for 
the FDA as it works to implement the Food Safety Modernization Act, 
FSMA. A landmark piece of legislation, FSMA was passed in 2011 to 
ensure the production of safe foods; yet the farmers and processors in 
Vermont and across the country are in need of science-based, clear 
technical assistance to aid in their compliance with this new set of 
rules. I was proud to learn recently that the University of Vermont was 
recently chosen to lead the Northeast Center to Advance Food Safety. 
This new collaboration will advance understanding and practice of 
improved food safety among the region's small and medium-sized produce 
growers and processors as they learn to comply with these new complex 
food safety standards.
  The FDA has been without a Commissioner for nearly a year and with no 
shortage of issues to address. I am pleased the Senate is moving one 
step closer to filling this position with tonight's vote. I look 
forward to working with Dr. Califf on the many pressing issues before 
the FDA.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  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

[[Page S901]]

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?

[[Page S902]]

  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.
  The PRESIDING OFFICER. The Senator from Connecticut.
  Mr. BLUMENTHAL. Madam President, I am so honored to follow my great 
friend and very eloquent advocate from Massachusetts, Senator Markey, 
who said much more powerfully than I can our reasons for opposing Dr. 
Robert Califf as the nominee for the head of the FDA. To say it very 
simply, this agency needs drastic reform. It needs an overhaul in the 
way that it approves these powerful painkilling substances that can be 
a gateway to addiction, whether to opiates or whether to heroin. I am 
proud to stand on the floor with Senator Markey, Senator Manchin, and 
others who feel that more must be done, that our Nation is lagging in 
addressing an epidemic.
  It is truly a public health hurricane that is sweeping Connecticut 
and our country. I have done roundtables around my State that are among 
the most moving public experiences of my service in the Senate and, 
indeed, my time for 20 years as attorney general on any public issue. 
It is an issue that concerns Iowa as well as every other State in the 
country. It is an issue that should bring us together on a bipartisan 
basis to address this true public health crisis.
  My reason for opposing Dr. Califf is, very simply, the failure of the 
FDA to recognize its own shortcomings and the prospect that there will 
be no change in the way the FDA is responding or failing to respond to 
this crisis if he is confirmed. With his confirmation, all that we can 
see ahead is more of the same.
  That is unacceptable. The FDA must be part of the solution or it will 
continue to be part of the problem. There is no question that the 
solution to this problem has to be multifaceted. In the roundtables 
that I have held around our State and in my conversations with the 
experts in this field and in the meetings that I have conducted with 
public health officials around the State with recovering addicts and 
their families, law enforcement, as well as public officials, I have 
seen that there is no single solution. There is no one-size-fits-all 
for recovering addicts, for communities, for different parts of the 
country. There has to be an emphasis on law enforcement because cutting 
off the supply has to be an objective, and law enforcement needs and 
deserves more support from this Nation and from the Congress. There has 
to be an emphasis on treatment and services. We are not going to arrest 
our way or jail our way out of this public health crisis, nor is 
treatment alone a sufficient solution. Part of the solution has to be 
more action from the FDA to oversee, scrutinize, and stop the pipeline 
of painkillers and opioids that are continuing to deluge our community.
  The urgency of this crisis is clear. In 2015 my State had more than 
700 prescriptions leading to overdose deaths. These fatal overdoses are 
also avoidable. The number of opioid-related deaths around the Nation 
has skyrocketed, and behind every one of these heartbroken families and 
communities is a realization that more must be done. We depend on the 
FDA to deal with these kinds of problems. The American people rely on 
this agency to implement a strong, regulatory approach to protect them.
  Unfortunately, the FDA has utterly and abjectly failed to protect the 
American people against the epidemic of opioid overuse. The FDA has a 
troubling history in this area, and I am well familiar with it because 
I highlighted it when I was the attorney general of our State, asking 
for stronger warnings for patients and consumers, asking for better 
oversight of oxycodone and related medicine, and asking for better 
supervision and education of the prescribers. And I asked in letters, 
in petitions, and in legal actions. In effect, the FDA has fueled this 
crisis by approving too many drugs with too little analysis. Too often, 
it has failed to use an advisory committee when approving a new opioid 
painkiller. It has demonstrated a troubling preference for speed over 
safety. It has expedited consideration at the risk of public health.

  It is essential to have an independent panel of experts to review and 
advise the agency on its approval of any opioid painkiller, giving the 
public a chance to provide input before a product comes to market. 
Unfortunately, in addition to instances where no advisory committee has 
been convened, the FDA has simply approved new drugs over committees 
objections. This failing to listen to warnings from experts harms 
public health and safety and confidence and credibility of this agency.
  One example, which some of my colleagues may remember, concerns the 
FDA's approval of the drug Zohydro. This high-dose, extremely potent 
opioid, which lacks abuse-deterrent properties, was approved in 2014 
despite strong objections from the scientific advisory panel that 
approved it. That panel voted 11 to 2 against approving the drug.
  The questionable oversight tactics the FDA has employed so far leave 
me with serious doubts about its ability to implement its recently 
released action plan. In this plan, the agency committed to convening 
advisory committees when approving any opioid painkiller that is not 
abuse-deterrent. This approach is, very simply, insufficient.
  We have seen how dangerous opioids can be. All opioids, whether or 
not they are classified as abuse-deterrent, should be reviewed by an 
independent advisory committee. And even if an opioid is classified as 
abuse-deterrent, that doesn't mean it cannot be abused or that an 
advisory committee shouldn't be consulted. The FDA itself recognizes 
that abuse-deterrent technology is in its infancy and independent 
advice is therefore essential.
  Unfortunately, instances where the FDA has failed to listen to its 
advisory committees are not limited to the context of drug approvals. 
In 2012 the agency recognized that opioids could lead to a number of 
dangerous outcomes--addiction, accidental overdose, and death. In 
response, the FDA implemented a risk-management strategy for extended-
release opioids, including requiring education for prescribers on safe 
prescription practices and the potential for abuse and addiction. Two 
years have passed--2 years since the first of these trainings was made 
available--but the FDA has yet to release information showing how many 
prescribers have been trained and educated on responsible prescribing 
practices. The FDA has ignored my call for this information to be 
released.
  The FDA has ignored the recommendations from two advisory committees 
that a similar strategy should be used for immediate-release opioids as 
well--a crucial issue, given that 91 percent of all opioids prescribed 
are in this category.
  I urge my colleagues to join with me in sending a signal to the FDA 
that more effective scrutiny and actions are vitally important. The FDA 
has failed to take this crisis seriously. Until it does, it is failing 
the American people. And a new FDA head must indicate there will be a 
sea change--a fundamental overhaul--in the way FDA oversees and 
protects the American people.
  I would like to highlight as well the crucial importance of 
finalizing the deeming rule, which is necessary to ensure the agency's 
authority over all tobacco products--also pertaining to addiction; the 
drug is nicotine--and that is essential to ensure that not only 
cigarettes but also e-cigarettes--that the companies that make them 
cannot market to children and to people who may be led to addiction to 
that drug.
  I am determined that the Nation do better in addressing this urgent 
crisis--a public health hurricane sweeping this country, as disastrous 
as any physical crisis of tornadoes or floods, maybe, in destroying 
lives and jeopardizing our national security.
  I am pleased to yield back to my colleague Senator Markey and to be 
joined by my great friend and colleague Senator Joe Manchin of West 
Virginia.
  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

[[Page S903]]

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.
  The PRESIDING OFFICER (Mr. Coats). The Senator from West Virginia.
  Mr. MANCHIN. First of all, Mr. President, I want to say to my 
colleagues, Senator Markey of Massachusetts and Senator Blumenthal of 
Connecticut, this doesn't have a partisan home. This is not a 
Democratic or Republican issue. This is an epidemic that is devastating 
our entire country. It doesn't matter whether someone comes from 
affluence or is socioeconomically challenged. Rich or poor, it makes no 
difference. What side of the track you live on makes no difference. 
This is an epidemic that hits us all in its devastation.
  If Senators will just talk to their communities, their law 
enforcement officials, they will tell you that over 80 percent of all 
crimes are drug-related. Look at the cost, look at the economy, and 
look at the devasation in the cost of lives it is taking. Something has 
to be done.
  We are expected to vote to confirm the President's nominee for 
Commissioner of the FDA, Dr. Robert Califf. Let me say this about our 
President, President Barack Obama: I think he is taking this seriously. 
He has come to the State of West Virginia, and I am very appreciative 
of that. He has seen firsthand the devastation it has taken in all 
aspects of life in West Virginia. We are a State that is hit as hard as 
if not harder than other States. It is the No. 1 killer in my State. 
There are more people dying by legal prescription drug abuse than any 
other cause. So the President came there and he saw that. I am just 
asking the President to make that major commitment to our having a 
cultural change by giving us someone who will shake it up from the top.
  I believe Dr. Califf is a good man. I really do. I believe he is a 
qualified man. I met with him and spoke with him, and I directly asked 
him--I said: Dr. Califf, you come from a culture where basically the 
large pharmaceutical industry that supplies these types of products to 
the market and expects the FDA to approve them are the people who have 
supported you for the last 20 years. It is just human nature that that 
is hard to change and hard to say no to.
  So with that being said, I said that I think we need a cultural 
change. I think he understands that and respects my position. I respect 
his. I just think he is the wrong person at this time of need for the 
position. We need to shake it up. He is going to continue to serve as 
Deputy Commissioner of the FDA's Office of Medical Products and 
Tobacco, but the Commissioner of the agency must be someone willing to 
lead in a different direction. With 51 Americans dying every day due to 
an opioid overdose, the FDA now more than ever needs a Commissioner who 
is a champion committed to changing the way this agency handles 
opioids.
  As I have said many times before, my State of West Virginia has been 
hit hardest. Drug overdose deaths have soared by more than 700 percent 
since 1999. We lost 600 West Virginians to opioids last year alone. But 
that is not the only problem in West Virginia. Since 1999 we have lost 
almost 200,000 Americans to prescription opioid abuse.
  I am here today to urge all my colleagues, before they take their 
vote today, to think about the citizens of their States who are 
suffering from prescription drug abuse. Think about all those you know 
who have lost a loved one due to this epidemic. Each and every one of 
us here knows someone whose life has been wrecked by legal prescription 
drug addiction.
  This is a silent killer. There is not a person whom I know in any 
community or any group in any setting whom I can't look at and say: 
There is not one of you in this room who doesn't know someone in your 
immediate family or among your extended family or friends who hasn't 
been affected. That is how rampant this is, but it is something we 
don't speak about much. We are concerned. It could be our son, could be 
a brother or a sister, could be a mother, father, aunt, or uncle, but 
we don't want to talk about it. We are afraid it has been stereotyped.
  We need a culture change. As the agency overseeing the approval of 
these addictive drugs, the FDA plays a critical role in this epidemic, 
and as my dear friend from Massachusetts, Senator Markey, said, the FDA 
might have to change what it stands for. It really has fostered this 
drug addiction more than any other agency. Think about the fact that it 
is being produced legally, approved by the Federal Government in a 
legal way, and it is being prescribed in legal ways. We are the most 
addicted Nation on Earth. Over 80 percent of the opioids consumed in 
the world are consumed by 5 percent of the world's population, that 5 
percent all living in this great country of ours. Something is wrong. 
Something is wrong, and everyone should be concerned about this.
  I tell our children and grandchildren, Mr. President, when I speak in 
schools--I say: You don't have to worry about another country ever 
taking us over militarily. We have the greatest military the world has 
ever known. We have the strongest economy, and we are the only ones who 
can correct the mistakes we have made in our economy because it is so 
strong. They do not think they have to take us on militarily or be 
worried about overtaking our economy; they are going to sit back and 
wait until we become so addicted we can't function. This is what we are 
dealing with, and this is why it is of such importance.
  The agency has been so callous about their approach to this epidemic. 
As a matter of fact, time and time again they have failed to consider 
the public's health. One would assume that if the Food and Drug 
Administration makes a decision that something is good and consumable, 
they would have looked at the effect it has on the public, the health 
and well-being of the citizens of this great Nation. Yet it has 
actively stood in the way of addressing this opioid abuse epidemic--and 
not only not considering it but prohibiting others from doing it.
  For years, the FDA delayed before finally agreeing to reschedule 
hydrocodone--to reschedule. Let me explain where I am coming from. When 
I first came to the Senate in late 2010, early 2011, I said: My 
goodness, we have Vicodin and Lortab, the most prescribed opioids on 
the market--more than any others. OxyContin had already been moved to a 
schedule II, and Vicodin and Lortab were schedule III. It took us 3 
years to get the FDA to reschedule Vicodin and Lortab and all opioids 
to a schedule II. It took 3 years--and after their own advisory 
committee overwhelmingly recommended that it be rescheduled. That means 
a doctor can only give out a 30-day supply at one time without a doctor 
visit. Under a schedule III, they can give out 90 days and continue to 
just call it in without seeing a doctor. They were putting this stuff 
out like they were M&Ms. So that changed and we finally got that done, 
but it took forever to get it done and we never could understand why.
  Since that change went into effect, we have seen the number of 
prescriptions for hydrocodone products, such as Vicodin and Lortab, 
fall by 22 percent. We know it worked because they were 
overprescribing. So 22 percent--that is 26 million fewer prescriptions 
and 1.1 billion fewer pills on the market. That is how much just that 
one change--it took 3 years but should have been done in 3 weeks. It 
took 3 years because the FDA stalled their decisionmaking. Then, after 
finally making the important step after 3 years, the next day--the next 
day that that was done--the FDA approved the dangerous drug called 
Zohydro. The next day, after 3 years of waiting to get all opiates to a 
schedule II, they came out and recommended Zohydro and approved it, 
even when their own experts--their

[[Page S904]]

own advisory committee made up of experts--recommended 11 to 2 against 
bringing this most powerful, lethal drug on the market.

  This drug has ten times the hydrocodone of Vicodin and Lortab, with 
the capability of killing an individual with just two pills, and just 
recently the FDA approved OxyContin for use for children 11 years of 
age. Can you believe that? They did that without having any experts or 
any advisory committee's consent or recommendations. This decision 
means that Pharma is now legally allowed to advertise OxyContin to 
pediatricians under certain circumstances.
  We have seen the devastating impacts of this type of advertising, and 
we have years of evidence that shows that drug use at an early age 
makes a child more likely to abuse drugs later in life. These decisions 
illustrate the FDA's inability to consider public health and assess the 
realities of this deadly epidemic. While I recently accepted the 
agency's decision to finally start listening to the advice of its 
expert advisory committee--they have just decided now they are going to 
start listening to their advisory committees. No way have they decided 
to take their recommendations. They are just going to listen. While 
this might be a step in the right direction, finally, of their 
listening and basically taking the advice of experts but not acting on 
it, I think is absolutely meaningless.
  The change at the FDA needs to be fundamental, and it needs to come 
from the top. We need a leader who changes the current way of thinking. 
Unless a major cultural change is implemented at the FDA, similar 
instances will continue to occur into the future. Meanwhile, our 
Nation's opiate epidemic continues only to worsen, and our friends and 
families are further torn apart by the impact of addiction.
  If Dr. Califf is confirmed today, I do not feel confident that this 
culture change is going to take place. Dr. Califf has close financial 
ties with the pharmaceutical industry. Between 2010 and 2014, Dr. 
Califf received money through his university salary and consulting fees 
from 26 Pharma companies, including opiate manufacturers. In the past, 
Dr. Califf has actually described the FDA regulation as a barrier--not 
a safeguard for public health, but a barrier.
  I believe the FDA needs new leadership, new focus, and a new culture. 
Dr. Califf's past involvement with the pharmaceutical industry shows 
that he would not be the person to do that. He would not have the 
impact or leadership capabilities the Nation needs to stem the tide of 
the opioid crisis. I believe the FDA must break its cozy relationship 
with the pharmaceutical industry and, instead, start a relationship 
with the millions of Americans impacted by prescription drug abuse. It 
is because of this belief that I am urging my colleagues to vote 
against the confirmation of Dr. Califf.
  My office has been absolutely flooded with stories from West 
Virginians and Americans who want their voices heard. I am going to 
read just a couple of letters because I think it is important to know 
the impact of these letters. I absolutely want you to hear it. And I 
know every State has been impacted the way my State has.
  This is Susan's story:

       My name is Susan. I am from West Virginia and I am the 
     mother of three children, ages 20, 16, and 14. My oldest 
     son's name is Zack. Zack is an addict.
       Zack grew up in a small town with his mother, father, 
     brother, and sister. He played sports throughout his 
     childhood including football, baseball, wrestling, and 
     basketball. He got good grades in school. He went to church 
     with his grandparents and wanted to be a preacher until the 
     age of 11 or 12.
       My husband and I divorced when Zack was 13, and it deeply 
     affected Zack. We moved to a new town where Zack and his 
     brother and sister started into a new school system. Around 
     the age of 15-16 Zack started self-medicating with nerve 
     pills----

  The PRESIDING OFFICER. I hate to interrupt the Senator, but the time 
has expired.
  Mr. MANCHIN. I didn't think there was a time barrier on this. I am so 
sorry. I ask unanimous consent to continue at least this letter.
  The PRESIDING OFFICER. Is there objection?
  Mr. ALEXANDER. Mr. President, reserving the right to object. The 
Senator from Washington has 5 minutes to go. I have 10 minutes to go. 
The vote is at 5:30. So I guess----
  Mr. MANCHIN. I should be done here in about 2 or 3 minutes. If I can 
just finish this letter--I have many more, but I will come back later.
  The PRESIDING OFFICER. The Senator from Washington.
  Mrs. MURRAY. Mr. President, I ask unanimous consent that following 
the Senator's remarks, I be allowed 6 minutes and the Senator from 
Tennessee be allowed 10 minutes.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.
  Mr. MANCHIN. Mr. President, I thank my colleagues.
  The PRESIDING OFFICER. Is there objection to the request of the 
Senator from West Virginia?
  Without objection, it is so ordered.
  Mr. MANCHIN. Continuing:

       Around the age of 15-16 Zack started self-medicating with 
     nerve pills, smoking pot, and drinking. Zack did his first 
     stint in rehab at the age of 16. He went to Florida to a 
     rehab facility because they were able to arrange everything 
     including his flight before we even got a call back from any 
     facility in our state. Zack was in treatment 60 days and 
     returned home. He was clean for several months and then 
     started using again. Zack graduated to using pain pills. From 
     there he started shooting up pain pills. A child who had a 
     horrific fear of needles was now injecting opiates to escape 
     his painful reality. Zack was robbing people and living house 
     to house and on the streets. Then when he figured out heroin 
     was a cheaper fix and more accessible, this became his new 
     drug of choice. Zack was arrested and given the chance to go 
     to rehab again. He completed another 2 trips to rehab, one 
     being 60-90 days and another being around 30. He came home, 
     relapsed and went to jail for 4 months due to failed drug 
     tests. He spent 4 months in regional jail without receiving 
     one counseling session or any help with substance abuse. When 
     he was released from jail he was very lost and didn't know 
     what to do with his life. He was clean several months before 
     relapsing again.
       Zack is now in a peer recovery program in West Virginia. He 
     is 20 years old and on his 4[th] stint in rehab. He is 
     fighting for his life in this program along with about 120 
     other men. He has been to jail, and has lost close to 20 
     people in his life due to overdoses.
       Being a mother of an addict is a nightmare. From learning 
     your child has this disease to fighting with insurance 
     companies and doctors to get your child treatment. When Zack 
     was a juvenile, I was told by treatment providers that 
     insurance companies did not consider substance abuse in 
     children a life threatening disorder. I had to run up in a 
     house when he ran away and handcuff him and take him to a 
     hospital high as a kite. I had CPS called on me for having my 
     intoxicated son handcuffed because I wasn't a police officer. 
     I had mental hygiene warrants lost. My son was released by a 
     hospital at a moderate risk to suicide and because of that 
     treatment centers wouldn't even consider admitting him into 
     their program. I was told by hospital staff that if I had a 
     medical card instead of private insurance or if my child was 
     a ward of the state, they could get him more help. I 
     contemplated quitting my job in order to get a medical card 
     for my son. I have been asked by rehab to take out loans in 
     order to get my son help. I have had to borrow thousands of 
     dollars from my family in order to get my son into treatment.
       I have driven my child to hospitals while he is nodding in 
     and out and I was crying so hard I couldn't see. I have 
     stayed up for 24 hours in a row watching my son detox in 
     hospitals. I have followed ambulances for miles transferring 
     him [to] facilities. I have missed Christmases, 
     Thanksgivings, and birthdays with my son. I have gone months 
     and months without a good night's sleep. I would cringe every 
     time the phone rang or there was a knock on the door. No 
     mother should ever have to just wait on that phone call or 
     for that [knock] on the door.
       I have also had to sit my other 2 children down and explain 
     to them that I don't love them any less than I do their 
     brother. I have had to tell them I have to dedicate more time 
     to Zack because I know the 2 of them will be okay but I have 
     to try and keep their brother alive.
       You see this epidemic is not only affecting the person who 
     is the addict. It is destroying families and communities. 
     Siblings are forgotten. Marriages and relationships are being 
     destroyed. Entire families are getting PTSD. Crime is at an 
     all-time high. The list goes on and on. The whole system is 
     broken when it comes to treating mental illness and 
     addiction. Until we get the money to fund treatment and more 
     treatment centers, this epidemic will continue to get worse.
       If my child had cancer, or any other chronic disease, he 
     would be able to get immediate treatment. He would be able to 
     get good treatment. Addiction is a disease that may start 
     with a poor choice, but is ultimately a disease. Until we are 
     able to provide adequate treatment immediately to those 
     suffering we will continue to lose a generation of people. I 
     pray that no one else has to experience the pain my family 
     and my son has experienced, but unfortunately, this disease 
     has entered into every community, every neighborhood, and 
     into most families. It's

[[Page S905]]

     just a shame that we live in the greatest nation in the world 
     and this is our reality.

  Mr. President, I thank my colleagues for allowing me that. I am very 
concerned about where our country is going and the role the FDA plays. 
We need a cultural change.
  I thank my colleagues.
  The PRESIDING OFFICER. The Senator from Washington.
  Mrs. MURRAY. Mr. President, I want to start by expressing my 
appreciation to Dr. Califf for accepting this nomination and continuing 
to offer his expertise in service of families and communities 
nationwide.
  I am glad this evening to have the opportunity to talk about the 
progress the FDA has made in recent years, the challenges that lie 
ahead, and why I believe Dr. Califf has the necessary leadership, 
background, and experience to guide the FDA at this very important 
time.
  The FDA oversees a quarter of all the goods sold in the United 
States, including more than $1 trillion in medical devices, cosmetics, 
and supplements. So the FDA Commissioner has a very critical 
responsibility to support health and well-being in this country.
  I am pleased that in recent years important progress has been made to 
improve FDA's services for patients and families, from approving the 
highest number of new drugs and biologics in 2014, to making progress 
toward a 21st-century food safety system as the Food Safety 
Modernization Act is implemented. These are important steps that have 
no doubt made a difference for families, but the FDA still faces 
significant challenges as we look ahead.
  As I have discussed with Dr. Califf, the FDA must continue to 
encourage the development of safe, effective cures and treatments for 
the chronic illnesses that impact far too many families across the 
country. The agency should prioritize tackling the threat of antibiotic 
resistant infections, such as the ones linked to the contaminated 
medical devices in my home State, and it should do more to ensure 
patients can always trust that the medical devices used in their care 
are safe and effective, including by building a robust postmarketing 
surveillance system for devices. The FDA should continue to strengthen 
its generic drug and biosimilar programs and needs to play a role in 
ensuring that all patients and families have access to the prescription 
drugs they need.
  In addition, our country faces urgent public health challenges that 
the FDA must help to address. To name a few, we need to move forward on 
making sure families have access to nutritional information and on 
ensuring our food supply is both safe and healthy. We need to put all 
the agency tools to work to stop tobacco companies from targeting our 
children. And we need to tackle the epidemic of opioid abuse that is 
ending and ruining lives in communities nationwide.
  I was pleased to see that the FDA put forward an action plan to help 
protect our communities from that crisis, and I look forward to working 
together with all of our colleagues to address that area.
  Another critical priority is ensuring the FDA always puts science 
over politics. As some on the floor today will remember, several of my 
colleagues fought long and hard to ensure that medical expertise, not 
ideology, governed decisionmaking on the sale of Plan B over the 
counter. Women and families have to be able to trust the FDA to not 
play politics with their health.
  After careful consideration and review, I am confident that Dr. 
Califf would contribute leadership and expertise as we work to tackle 
all of these challenges. He is a strong nominee for the role of FDA 
Commissioner. He has an impressive history of leadership and management 
experience, especially at Duke University, where he led one of our 
largest academic clinical research organizations. He would bring to 
this new role a record of advancing medical breakthroughs on 
challenging illnesses through clinical trials and working to translate 
NIH lab discoveries into usable medical treatments for patients. Our 
review of his record demonstrates a longstanding commitment to 
transparency in relationships with industry and working to ensure 
academic integrity. Dr. Califf has made clear he will continue to 
uphold those values and prioritize a strong, independent FDA as 
Commissioner. His nomination received letters of support from 128 
different physician and patient organizations, as well as the strong, 
bipartisan support of the members of our HELP Committee.
  I have approached this nomination focused on the best interests of 
families and communities in my State and across the country and in 
making sure the FDA puts them first in all its work. I believe Dr. 
Califf would be a valuable partner in this effort as FDA Commissioner. 
So I encourage all of our colleagues to join me in supporting his 
nomination, and I look forward to working with all of us to strengthen 
health and well-being for the families and communities we serve.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Tennessee.
  Mr. ALEXANDER. Mr. President for the information of Senators, the 
vote will be in about 10 minutes, following my remarks, and I want to 
make my remarks because of the importance of this nomination.
  I join the Senator from Washington State in urging our colleagues to 
vote to end debate on the nomination of Dr. Califf and then tomorrow to 
vote for him.
  We are very fortunate to have a man of this distinction accept this 
position. I congratulate the President for his nomination. I note, as 
the Senator from Washington said, that his nomination has been widely 
applauded across this country and received strong bipartisan support in 
our committee after an intense investigation.
  I ask unanimous consent to have printed in the Record, following my 
remarks, a list of 124 organizations that have submitted letters in 
support of Dr. Califf's nomination to our committee. The list does not 
include press releases or other statements of support that were not 
submitted to the committee.
  Dr. Califf will be in charge of the Food and Drug Administration. 
That agency is responsible for the safety and effectiveness of our 
Nation's medicines, devices, and other medical products in protecting 
our country's food supply.
  It is not too much to say that this job affects virtually every 
single American. It is a huge job. The FDA affects nearly every single 
American and regulates about one-quarter of all consumer spending in 
the United States--about $4 trillion annually. It is responsible for 
product areas as diverse as prescription drugs for humans as well as 
for animals, for medical devices, for biologics, for cosmetics, over-
the-counter medications, food, and tobacco.
  To accomplish this, the FDA employs 15,700 full-time employees 
worldwide, with an annual total budget of $4.505 billion from funds 
appropriated by the Congress and user fees paid by the industries it 
regulates. Managing an enterprise of this size is no small undertaking. 
It requires strong leadership and a steady hand.
  Last year, on September 17, the President nominated Dr. Califf. My 
staff and I reviewed the nomination carefully. I found him to be well 
qualified to take charge of the FDA. He is one of the Nation's leading 
cardiologists. He was a professor at one of the Nation's top medical 
schools for over 30 years. He is an expert on clinical research. He has 
been recognized by the Institute for Scientific Information as one of 
the top 10 most cited authors, with more than 1,200 peer-reviewed 
publications. He has managed large organizations, including the Duke 
Clinical Research Institute as a founding director. In his current 
position, he is FDA's Deputy Commissioner for Medical Products and 
Tobacco, in which capacity he oversees the regulation of products 
including human drugs, biological products, medical devices, and 
tobacco.
  He has conducted scores of important clinical trials and has advised 
and worked on research with some of the Nation's leading 
pharmaceuticals and biopharmaceutical companies.
  In addition, Dr. Califf, like every full-time nominee, has been 
through an indepth process to review his background. Before the 
President even announced his nomination, there was an extensive vetting 
by the White House and the FBI. He submitted paperwork to the Office of 
Government Ethics, which carefully reviewed that information looking 
for conflicts of interest.

[[Page S906]]

The form he submitted is public and includes every source of income 
over $200, every asset worth more than $1,000, and every potential 
conflict that the Office of Government Ethics determined would require 
a recusal.
  Before our committee held a hearing, Dr. Califf answered 37 pages of 
questions from the bipartisan leadership of the committee, including 
confidential questions on financial information, and he responded to 
written followup questions. His responses included over 3,000 pages of 
articles and lectures my staff and Senator Murray's staff reviewed and 
any Member of the Senate could review.
  On November 17, the HELP Committee held a hearing on his nomination. 
He provided testimony and took questions. Afterward, he answered 100 
pages of written questions. Throughout this process, we have carefully 
reviewed everything submitted and not found anything that would call 
into doubt Dr. Califf's ability to lead the FDA fairly, ably, and 
impartially.
  I am pleased to support his nomination. I am pleased the full Senate 
now will have an opportunity to vote on that nomination in a prompt 
way.
  Dr. Califf's nomination comes at an important time for the FDA. For 
the past year, the FDA has been operating without a confirmed 
Commissioner. There are important issues there. It needs a confirmed 
Commissioner to provide the leadership that will carry the agency into 
the future.
  One issue that has been on many of our minds is how to make sure 
American patients have access to affordable drugs. Of course, the FDA's 
job is not to set drug prices. I am pleased Dr. Califf agreed at his 
confirmation hearing that he understands the FDA's role is to make sure 
that drugs are safe and effective, not to regulate their price, but the 
FDA can help lower drug prices by approving generic drugs and other 
products as quickly as it possibly can so there is more choice and 
competition in the market.
  There are thousands of applications for generic drugs sitting at the 
FDA awaiting approval. Addressing this backlog, and reviewing new 
applications as expeditiously as possible, will allow lower-cost drugs 
to be available to patients. I am confident the FDA can improve its 
performance. Just last month, our committee held a hearing on this 
issue and the FDA was optimistic about making progress.
  We also needed a confirmed Commissioner who can guide the agency to 
make sure it keeps pace with medical innovation. There has never been a 
more exciting time in medical research than today. We know more about 
biology and medicine than ever before, and knowledge is being applied 
in innovative ways.
  We are talking about actually curing, not just treating cancers. We 
are using 3-D printing to help doctors replace knees. In one case the 
FDA has approved a drug to treat epilepsy that is made by 3-D printing. 
The President has announced a Precision Medicine Initiative designed to 
promote personalized treatments to take into account an individual's 
genes, environment, and lifestyle. These are exciting developments.
  First, the FDA needs to make sure that regulation is appropriate. Too 
much regulation could reduce investment. Not enough regulation could 
lead patients to getting therapies that are not safe and effective.
  At the same time, the FDA will need to make sure its policies and its 
procedures, many of which were adopted decades ago, are capable of 
addressing the technologies of today and tomorrow. Second, as we 
continue to make medical advances, the FDA will need to keep up with 
the science and rely on expertise outside the FDA when appropriate. 
Doing that will require a leader who can manage a large and complex 
organization--not just on big policies that make headlines but on day-
to-day matters such as hiring and training scientists on the core 
mission and integrating information technology.
  Medical products take more time and money to discover, develop, and 
reach American patients than ever before. We hear stories about drugs 
and devices that are available to patients outside the United States 
before they become available here, often because it is difficult for 
manufacturers to navigate the FDA's often unclear approval 
requirements. It often takes over a decade to develop a drug that gains 
marketing approval in the United States. According to one recent study, 
the costs have tripled in the last 10 years.
  Senator Murray and I are working with our colleagues on our committee 
on bipartisan legislation to help get safe, cutting-edge drugs, medical 
devices, and treatments into Americans' medicine cabinets and doctors' 
offices more quickly.
  We held a markup on February 9, in which we approved seven important 
bills with bipartisan support that will help both manufacturers and the 
FDA to get innovative treatments to patients more quickly. They are all 
bipartisan bills.
  Senators Bennet, Warren, Burr, and Hatch offered the Advancing 
Targeted Therapies for Rare Diseases Act of 2015, S. 2030. If you are 
the parent of a child suffering from a rare disease like Cystic 
Fibrosis, this bill increases the chances that researchers will find a 
treatment or cure for your child's disease. It does that by allowing 
researchers to reuse good data they have collected, because it is hard 
to find enough patients for a clinical trial studying a rare disease 
with multiple genetic mutations.
  Senators Burr and Franken offered the FDA Device Accountability Act 
of 2015, S. 1622. If you are one of the millions in our country who 
will need a medical device such as a pacemaker or knee implant, this 
bill will help drive the faster development of better devices--cutting 
unnecessary red tape from the review process for these devices.
  Senators Baldwin and Collins offered the Next Generation Researchers 
Act, S. 2014. If you are a smart young scientist who wants to find a 
cure for cancer, this bill will help the National Institutes of Health 
create opportunities for you to get funding for your research, so that 
you don't head to another country or into another field. It will also 
help you pay back more of your student loans.
  Senators Kirk, Bennet, Hatch, Murkowski, Isakson, and Collins offered 
the Enhancing the Stature and Visibility of Medical Rehabilitation 
Research at NIH Act, S. 800. If you are one of the millions of 
Americans with disabilities, illnesses and chronic conditions that 
require medical rehabilitation--maybe you suffered a stroke and need to 
relearn how to walk--this bill will help ensure that the government is 
supporting research that will help you have the best chance at 
rehabilitation.
  Senators Isakson and Murphy offered the Advancing Research for 
Neurological Diseases Act of 2015, S. 849. If you are the child of a 
parent with Parkinson's, this bill will help speed a treatment or cure 
for your parents' disease by helping researchers have access to more 
data on neurological diseases.
  Senator Murray offered the Preventing Superbugs and Protecting 
Patients Act, S. 2503. If you suffer from something as common as 
indigestion, or perhaps something scarier like cancer, that requires 
putting a scope down your throat to diagnose or better understand your 
ailment, and this bill will help ensure that the scope the doctor uses 
is clean and doesn't give you an infection.
  I offered with Senator Murray the Improving Health Information 
Technology Act, S. 2511. If you are anyone who has ever changed doctors 
or needs to see a specialist and you want to be sure the new doctor you 
are seeing knows your medical history so he or she can help you best, 
this bill takes several steps to get health records flowing between 
doctors, hospitals, and patients to help realize the promise of health 
information technology by turning these systems from something that 
doctors and hospitals dread into something that actually helps 
patients.
  We will be taking up more of these proposals in March and in April.
  The next FDA Commissioner will have a lot of work to do, both to 
implement the legislation we are passing and to take the existing 
authority and make sure we help patients as best we can. He will be 
dealing with one-quarter of the consumer spending in the United States 
and affecting virtually every American. He is the right person for this 
job.
  I strongly encourage my colleagues to vote for Dr. Califf, first 
today, to end debate on the nomination, and tomorrow, once that has 
ended, to confirm him in this important position.

[[Page S907]]

  I yield the floor.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                        Organizations in Support


     Dr. Robert Califf--Nominee for Commissioner of Food and Drugs

       The following 124 organizations have submitted letters in 
     support of Dr. Califf's nomination to the Committee on 
     Health, Education, Labor & Pensions. The list does not 
     include press releases or other statements of support that 
     were not submitted to the Committee.
       Accelerate Brain Cancer Cure, Accelerated Cure Project for 
     Multiple Sclerosis, Action to Cure Kidney Cancer (ACKC), 
     Addario Lung Cancer Medical Institute, Adenoid Cystic 
     Carcinoma Research Foundation, Alliance for Aging Research, 
     Alliance for Lupus Research, Alpha-1 Foundation, American 
     Academy of Pediatrics, American Association for Cancer 
     Research (AACR), American Cancer Society Cancer Action 
     Network, American College of Cardiology (ACC), American Heart 
     Association, American Sleep Apnea Association, American 
     Society for Reproductive Medicine, American Society of 
     Clinical Oncology (ASCO), American Statistical Association, 
     Association of American Cancer Institutes (AACI), Association 
     of American Medical Colleges.
       BCM Families Foundation, Bert's Big Adventure, Bonnie J. 
     Addario Lung Cancer Foundation, C-Change, Cancer Research 
     Institute, Cancer Support Community, CancerCare, Celiac 
     Disease Foundation, Center for Medical Technology Policy, CEO 
     Roundtable on Cancer, Chase After a Cure, Childhood Cancer 
     Guides, Children's Cause for Cancer Advocacy, Citizens United 
     for Research in Epilepsy, Clinical Research Forum, Coalition 
     of Cancer Cooperative Groups, COPD Foundation, Cure AHC, Cure 
     SMA, CureHHT, Cutaneous Lymphoma Foundation, DC 
     Candlelighters Childhood Cancer Foundation, Depression and 
     Bipolar Support Alliance, Dysautonomia International, 
     Dystonia Medical Research Foundation, Eastern Cooperative 
     Oncology Group (ECOG), EveryLife Foundation.
       Facing Our Risk of Cancer Empowered (FORCE), FasterCures, a 
     center of the Milken Institute, FH Foundation, Fight 
     Colorectal Cancer, Foundation Fighting Blindness, Foundation 
     for Mitochondrial Medicine, Foundation for Prader-Willi 
     Research, Friedreich's Ataxia Research Alliance, Friends of 
     Cancer Research, Gastroparesis Patient Association for Cures 
     and Treatments, Genetic Alliance, Geoffrey Beene Foundation, 
     Glaucoma Research Foundation, Grandparents In Action, Heart 
     Failure Society of America, Heathcare Leadership Council, 
     Hematology/Oncology Pharmacy Association, Hepatitis 
     Foundation International, Institute for Clinical Bioethics, 
     Institute of Catholic Bioethics, International Myeloma 
     Foundation, JDRF, Kids v. Cancer, Leukemia & Lymphoma 
     Society, Lung Cancer Alliance, LUNGevity Foundation, Lupus 
     and Allied Diseases Association, Lupus Research Institute, 
     LymeDisease.org, Lymphangiomatosis & Gorham's Disease 
     Alliance.
       Martin Truex Jr. Foundation, Mattie Miracle Cancer 
     Foundation, Melanoma Research Alliance, Men's Health Network, 
     MLD Foundation, MPN Research Foundation, Multiple Myeloma 
     Research Foundation, Muscular Dystrophy Association, Myotonic 
     Dystrophy Foundation, National Alliance on Mental Illness 
     (NAMI), National Alopecia Areata Foundation, National Brain 
     Tumor Society, National Health Council, National Multiple 
     Sclerosis Society, National Organization for Rare Disorders 
     (NORD), National Patient Advocate Foundation, National PKU 
     Alliance, NCCS, New England Journal of Medicine, New York 
     Stem Cell Foundation, Oncology Nursing Society, Oncology 
     Nursing Society (ONS), Pac2, Parent Project Muscular 
     Dystrophy.
       Pediatric Congenital Heart Association, Personalized 
     Medicine Coalition, PFO Research Foundation, Phelan-McDermid 
     Syndrome Foundation, Prevent Cancer Foundation, Progeria 
     Research Foundation, Prostate Cancer Foundation, Reflex 
     Sympathetic Dystrophy Syndrome Association, Research!America, 
     Rett Syndrome Research Trust, Sjogren's Syndrome Foundation, 
     Society of Women's Health Research, Solving Kids' Cancer, 
     Sophia's Fund, St. Baldrick's Foundation, Stand Up To Cancer, 
     T1D Exchange, The ALS Association, The diaTribe Foundation, 
     The Hide and Seek Foundation, The Nicholas Conor Institute, 
     The Swifty Foundation, USAgainstAlzheimer's, Wake Up 
     Narcolepsy.

                          ____________________