[Congressional Record (Bound Edition), Volume 162 (2016), Part 1]
[Senate]
[Pages 991-992]
[From the U.S. Government Publishing Office, www.gpo.gov]




                      PRESCRIPTION DRUG ADDICTION

  Mr. MARKEY. Madam President, I am here to talk about a public health 
epidemic that kills more people in the United States every year than 
gun violence or motor vehicle accidents. Last year, drug overdoses 
killed nearly 50,000 Americans. Almost 60 percent of those overdoses 
were caused by prescription opioids or heroin. Drug overdoses are 
increasing the death rate 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 them the first generation since the 
time of the Vietnam war to experience higher death rates in early 
adulthood than the generation that preceded them.
  So we ask ourselves: What specifically is causing this tidal wave of 
addiction and overdoses? Well, the answer is clear. Over the last 10 
years, the Drug Enforcement Agency has increased the amount of 
oxycodone it has approved for manufacturing by 150 percent.
  For 2016, the DEA has told Big Pharma it is OK to make nearly 1.4 
million grams of oxy. That is enough for almost 15 billion 10-milligram 
pills. Let me say that again: That is enough for almost 15 billion 10-
milligram pills to be sold in America this year. That is a full bottle 
of potent painkillers for every man, woman, and child in the United 
States of America for 2016. This tsunami of opioid addiction is 
swallowing families as quickly as Big Pharma wants Americans to swallow 
its pills. Yet, despite this raging epidemic, you 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 up a sign in 
its window: ``No Help Wanted.'' The FDA began turning its back on 
advisory committees in 2013 when an expert panel established to review 
the powerful new opioid painkiller Zohydro voted 11 to 2 against 
recommending its approval, but the FDA approved the drug anyway, 
overruling the concerns voiced by experienced physicians on the panel. 
Those experts criticized the agency for ignoring this incredible 
growing epidemic. The advisory panel warned that this Oxycontin 
epidemic--this heavily abused prescription painkiller that the FDA 
first approved back in 1995--needed a new test for safety. They warned 
about the growing dangers of addiction, abuse, and dependence 
associated with the 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 the warning of real-world dangers of abuse and dependence on 
these new supercharged opioid painkillers, the FDA willfully blinded 
itself to 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 2015, the 
FDA did it again. This time it bypassed 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 called for an 
advisory committee when a question of pediatric dosing is involved. In 
other words, there is a special category when children are involved 
that calls for advisory committees, and the FDA ignored that.
  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. Why? 
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 
into the marketplace.
  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 
only to tell doctors the proper doses for children who needed the drug.
  Well, 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 use experts to determine if the opioid painkillers are safe for 
our families. We need to immediately reform the Food and Drug 
Administration opioid approval process if we want to stop this epidemic 
of prescription drug and heroin addiction.
  Last week I placed a hold on the nomination of Dr. Robert Califf to 
head the FDA. Before I can support this nomination, the FDA must make 
three needed changes to its opioid approval process. First, the FDA 
needs to make sure that every opioid approval question is reviewed by 
an external panel of experts. Second, the FDA needs to consider 
addiction, abuse, and dependence as part of its determination of 
whether an opioid is safe. The FDA cannot continue to operate as if 
safety just means dosage, when it should include all of the dangers, as 
well, of these painkillers. And third, the FDA should rescind its 
decision on Oxycontin for kids and then convene an advisory panel, as 
it should have done in the first place. Then the FDA can consider the 
Oxycontin-for-kids decision with the benefit of that panel's 
independent advice and with the proper meaning of safety in mind.
  The FDA must commit to shift the way it approaches and evaluates 
addiction before I can consider supporting Dr. Califf's nomination.
  The prescription drug and heroin epidemic knows no geographic 
boundaries, and our response should know no political boundary. That is 
why Majority Leader Mitch McConnell and I worked together to identify 
solutions to this crisis. Last spring, Senator McConnell and I joined 
together in calling for a Surgeon General's report on the opioid 
crisis.
  Last fall, Surgeon General Vivek Murthy announced that he will be 
issuing a new report on the substance abuse crisis this year. Fifty 
years ago, there was a historic report on smoking that changed the way 
our country viewed that. This is the same kind of report that we need 
from our Surgeon General for our country to see, but that is just the 
first step in a larger comprehensive national strategy that I am 
fighting for this year.
  We need to stop the overprescription of pain medication that is 
leading to heroin addiction and fueling this crisis. That starts with 
the prescribers. We need to ensure that all prescribers of opioid 
painkillers are educated about the dangers of addiction and appropriate 
and responsible prescribing practices.
  I have a bill that requires every prescriber of opioid pain 
medication in this country, as a condition of receiving their DEA 
prescribing license, to be trained in the best practices of using pain 
medications and methods to identify and manage an opioid-use disorder. 
Stopping overprescription also includes narrowing the pipeline at the 
front end.
  The PRESIDING OFFICER (Mr. Rounds). The Senator's time has expired.
  Mr. MARKEY. Mr. President, I ask unanimous consent to continue for 2 
additional minutes.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.
  Mr. MARKEY. Mr. President, this means that the DEA needs to reduce 
the quotas of oxycodone and hydrocodone that it approves for 
manufacture each year. The DEA is allowing Big Pharma to manufacture 
too

[[Page 992]]

many of these pain pills. Although the United States is less than 5 
percent of the world's population, Americans consume 80 percent of the 
global supply of opioid painkillers and 99 percent of the world's 
supply of hydrocodone, the active ingredient in Vicodin. Tragically, we 
have become the ``United States of oxy.''
  With the opioid epidemic reaching epic proportions, our Federal 
budget should reflect the magnitude and importance of investing in 
treatment and recovery services.
  In Massachusetts, approximately 65,000 people are currently dependent 
on opioids. Some 50,000 need treatment but are not receiving it. 
Treatment for prescription drug and heroin addiction is absolutely at 
the top of the list of the things this Congress should deal with, and 
that is why we need to work together. We need to make sure that the 
treatment is there for each of these patients, and that includes 
ensuring that patients receive from a physician the help they may need 
from Suboxone. Right now, that is denied to many different patients.
  I have been in Congress for 39 years. I have never actually seen an 
issue like this that has grown so quickly and affects so many families 
in our country. Not a day goes by in the State of Massachusetts where 
someone doesn't come up to me and talk to me about a family member who 
has been affected by this epidemic. It is time for us to join together 
in a bipartisan fashion to produce the kind of legislation to give hope 
to families and let them know that relief is on the way, and that 
prevention and treatment will be there to help their families deal with 
this crisis.
  I hope we can accomplish that goal this year, and I believe we can do 
it on a bipartisan basis.
  I yield back the remainder of my time with thanks to the Senator from 
Alaska for her indulgence.

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