[Congressional Record (Bound Edition), Volume 162 (2016), Part 2]
[Senate]
[Pages 1849-1850]
[From the U.S. Government Publishing Office, www.gpo.gov]




                      NOMINATION OF ROBERT CALIFF

  Mr. MARKEY. Mr. President, I am here to speak in opposition to the 
nomination of Dr. Robert Califf to be the head of the Food and Drug 
Administration.
  I understand that Leader McConnell has asked that cloture be filed on 
Dr. Califf's nomination. I understand that. I appreciate it. But we 
need to have a debate in this country on opioids. While I am 
disappointed that the majority leader is taking this step, I am 
committed to continuing to work on this issue, and using Dr. Robert 
Califf's nomination is the means by which we can have a debate here on 
the floor of the Senate on these issues.
  (Mr. McCONNELL assumed the Chair.)
  I am here to speak about a public health epidemic that every year 
kills more people in the United States than gun violence or motor 
vehicle accidents. What does this epidemic look like? Well, it looks 
like this: Last year 30,000 Americans died of an opioid overdose. More 
than 1,300 of those were from my home State of Massachusetts. In the 
city of Brockton, MA, last month, in January, in the span of 48 hours, 
40 people overdosed on opioids. I will say that again. In Brockton, in 
48 hours, 40 people overdosed on opioids.
  Between 2000 and 2013, the rate of death from heroin overdoses nearly 
quadrupled. The United States is less than 5 percent of the world's 
population, but we consume 80 percent of the world's opioid pain 
killers. Drug overdoses are increasing the death rates of young adults 
in the United States to levels not experienced since the AIDS epidemic 
more than 20 years ago. These skyrocketing death rates make these young 
adults the first generation since the time of the Vietnam war to 
experience higher death rates in early adulthood than the generation 
that preceded it.
  Let's compare what we did as a nation when we confronted other deadly 
epidemics. A bipartisan majority in Congress funded more than $5 
billion to respond to Ebola. We dispatched the medical community and 
public health experts. We built entire facilities to ensure we stopped 
the spread of the deadly virus. Today, the Obama administration is 
asking Congress for $1.8 billion in emergency funding to fight the Zika 
virus. Imagine if we applied the same commitment, the same urgency, the 
same level of resources to the prescription drug and heroin epidemic.
  Yet, despite this raging epidemic, one would think the Food and Drug 
Administration--the agency responsible for the safety of all 
prescription drugs in the United States--would welcome every bit of 
expert advice it can get from doctors and other public health 
professionals. In fact, the FDA's own rules call for it to establish an 
independent advisory committee of experts to assist the agency when it 
considers a question that is controversial or of great public interest, 
such as whether to allow a new addictive prescription painkiller to be 
marketed in the United States. Instead, the FDA has put a sign in its 
window: No Help Wanted. That is what this nomination of Dr. Robert 
Califf is all about.
  The FDA began turning its back on advisory committees in 2013 when an 
advisory panel to review the powerful opioid painkiller Zohydro voted 
11 to 2 against recommending its approval. But the agency approved the 
drug anyway, overruling the concerns voiced by experienced physicians 
on the panel. Those experts criticized the agency for ignoring the 
growing epidemic fueled by OxyContin--the heavily abused prescription 
painkiller the FDA first approved back in 1995. They warned about the 
growing dangers of addiction, of abuse and dependence associated with 
this entire class of opioid painkillers. Justifiably, the FDA was 
lambasted for its decision to approve Zohydro by public health experts, 
doctors, Governors, and Members of Congress. But despite those warnings 
of the real-world dangers of abuse and dependence on these new, 
supercharged opioid painkillers, the FDA willfully blinded itself to 
the warning signs.
  In 2014, in the wake of the Zohydro decision, the FDA twice skipped 
the advisory committee process altogether when it approved the new 
prescription opioids Targiniq and Hysingla.
  Then, in August of 2015, the FDA did it again, this time by bypassing 
an advisory committee on the question of a new use for OxyContin for 
children aged 11 to 16. This time the FDA even ignored its own rules 
that specifically call for advisory committee advice when a question of 
``pediatric dosing'' is involved.
  At this point, it became clear that the FDA was intentionally 
choosing to forgo an advisory committee in order to avoid another 
overwhelming vote recommending against approval of a prescription 
opioid. And why did they do it? Well, because the FDA would then have 
had to ignore yet another group of experts in order to continue its 
relentless march to put more drugs on the market.
  With the OxyContin-for-kids decision, the FDA's reckless attitude 
toward expert advice on drug safety went too far. Children whose brains 
are not yet fully developed are especially vulnerable to drug 
dependency and abuse. Yet the agency focused its so-called safety 
analysis only on concerns about proper dosing, saying that it needed to 
tell doctors the proper doses for children who needed the drug. That is 
just plain wrong. We use experts to determine if child car seats are 
safe, if toothpaste is safe, and if vaccines are safe. We should also 
use experts to determine if those opioid painkillers are safe for the 
children in the United States of America.
  We need to immediately reform the Food and Drug Administration's 
opioid approval process if we want to stop this epidemic of 
prescription drug and heroin addiction in the United States.
  When I placed a hold on the nomination of Dr. Califf to head the FDA, 
I called on the FDA to commit to convening an advisory panel of outside 
experts for every single opioid approval question it reviewed. Here is 
how the FDA responded: It responded by committing to convene outside 
experts but only for opioids that are not abuse-deterrent. Let's be 
clear. I want everyone in this Chamber to understand this: ``Abuse-
deterrent opioid'' is an oxymoron, like ``jumbo shrimp'' or 
``congressional expert.'' There is no such thing. When we hear the term 
``abuse-deterrent,'' think of pills that are tamper-resistant. They are 
supposed to be difficult to crush or chew

[[Page 1850]]

or cut open or tamper with. But nothing about abuse-deterrent opioid 
prevents addiction. There is no such thing as abuse deterrence if you 
are suffering from addiction and have access to the Internet, where you 
can find out just how easy these painkillers are to manipulate and 
abuse. Whether an opioid is abuse-deterrent or not hasn't prevented 
tens of thousands of people who have had their wisdom teeth extracted 
or experienced lower back pain from getting addicted to these 
painkillers.
  By refusing to convene advisory committees to reform all of its 
opioid approval decisions, the FDA continues to ignore outside experts 
who could help stem the tide of tragic deaths and overdoses plaguing 
this country.
  This all started back with the FDA's 1995 approval of the original 
OxyContin--the moment in history that is widely recognized as the 
starting point for the prescription opioid and heroin overdose epidemic 
in the United States. It started with the FDA. The FDA approved the 
original version of OxyContin--an extended-release opioid--believing 
that it ``would result in less abuse potential, since the drug would be 
absorbed slowly and there would not be an immediate `rush' or high that 
would promote abuse.'' Since then, the claims that opioid is abuse-
deterrent have time and again proven oxymoronic.
  FDA's own guidelines recognize the inherent contradiction in the term 
``abuse-deterrent,'' explaining:

       It should be noted that [abuse-deterrent] technologies have 
     not yet been proven successful at deterring the most common 
     form of abuse--swallowing a number of intact capsules or 
     tablets to achieve a feeling of euphoria. Moreover, the fact 
     that a product has abuse-deterrent properties does not mean 
     there is no risk of abuse.

  That is from the FDA's own guidelines.
  In many cases, the FDA approved so-called abuse-deterrent opioids 
despite warnings from the medical community about the potential for 
abuse. And when it wasn't turning a blind eye to the warnings of 
experts, the FDA simply didn't engage them at all in approval of 
opioids with abuse-deterrent properties. With numerous approvals of so-
called abuse-deterrent opioids since 2010, the agency convened advisory 
committees for less than half of them.
  This issue of abuse deterrence is not a hypothetical concern. The new 
policy announced by the FDA would not have guaranteed an advisory panel 
for the OxyContin that is on the market today and being sold in tens of 
millions of doses or for the other recently approved opioids that have 
raised serious concerns from public health and medical experts from 
around our country. The FDA is attempting to set up a system where 
nothing really changes.
  We will not solve the prescription drug crisis with an FDA that 
operates with business as usual and continues to turn its back to 
external experts. The FDA needs to welcome outside expert advice and 
must convene expert advisory panels for all opioid approval decisions, 
period. Until the FDA makes that commitment, I am going to continue to 
raise my voice in opposition to the nomination of Dr. Califf.
  This is an issue that is central in our country. The terrorist phone 
call that families in America are afraid of getting is not one from 
overseas; it is that a member of their family has fallen victim to this 
prescription drug opioid crisis. It is in every city, every town in our 
country. We have seen a quadrupling of the number of heroin deaths in 
our country in the last 13 years, and 80 percent of them started with 
OxyContin, with Percocet, with one of these prescription drugs.
  We need the FDA to do the right thing, and until they do, we need to 
debate out here on the floor what the responsibilities will be of this 
new FDA Commissioner, because they have been unwilling to change their 
policy. Until they do, these people and communities all across our 
country are going to be helpless. They are going to be helpless because 
families think that if a bottle is given to them by an expert, they can 
trust it. And when their children die--when their children die--they 
ask themselves the question: Could I have done more? It starts with the 
FDA. It starts with MEA, mandatory education for physicians. It starts 
there. If we don't do this, then those families are still going to be 
having the same result year after year after year.
  I thank the majority leader for sitting and hearing my objections. 
The majority leader and I have had many conversations about this 
subject, and I know of his deep concern on this issue. I think this is 
something that can be corrected. I hope it can be corrected. It must be 
corrected.
  I thank the majority leader for staying to hear my presentation.
  I yield the floor.

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