Comprehensive Addiction and Recovery Act of 2015

Floor Speech

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Mr. MARKEY. Madam President, before I begin, as we discuss the Comprehensive Addiction and Recovery Act, I would like to take a moment to thank Senator Whitehouse for his role in developing the bill and bringing it this far. I also convey my gratitude to Minority Leader Reid and the ranking member of the Judiciary Committee, Senator Leahy, for their excellent staffs and for urging that my amendments--which I will address momentarily--be a part of the discussion and for managing the negotiations on this bill. I also thank Senator Murray, the ranking member of the HELP Committee, for help and counsel on amendments.

Let us pause for a moment and consider the causes of the prescription opioid and heroin epidemic gripping our country. Understanding the causes will help us focus on the right solutions. Three distinct parties bear much of the blame for this public health crisis.

First, there is Big Pharma. In the mid-1990s, the seeds of this epidemic were planted with the aggressive, misleading, and ultimately criminal marketing of the powerful opioid painkiller, OxyContin by Purdue Pharma. Perdue claimed OxyContin was not addictive and couldn't be abused. Neither of those claims turned out to be true. Purdue Pharma built a massive marketing and sales program for OxyContin. From 1996 to 2000, Purdue Pharma's sales force more than doubled from more than 300 sales representatives to almost 700 sales representatives. In 2001 alone, Purdue gave out $40 million in bonuses to its burgeoning sales force. As a result of these sales and marketing efforts, from 1997 to 2002, OxyContin prescriptions increased almost tenfold, from 670,000 in 1997 to 6.2 million in 2002.

Purdue's marketing of OxyContin broke the law. In 2007, Purdue Pharma paid $600 million in fines and other payments after pleading guilty in Federal court to misleading regulators, doctors, and patients about the risks of addiction to OxyContin and its potential for abuse.

Second, Purdue Pharma's criminal wrongdoing did not occur in a vacuum. The Federal Government helped to enable this epidemic. The Federal Drug Enforcement Administration is responsible for approving the annual production quotas for pharmaceutical companies to manufacture oxycodone, the principal ingredient in OxyContin. From 1996 to 2016, the Drug Enforcement Administration obliged Big Pharma and increased by almost 150 percent the amount of oxycodone authorized for manufacture. In 1996, the DEA authorized U.S. pharmaceutical companies to make the equivalent of 6 billion 10-milligram OxyContin pills. By 2016, that figure had increased to almost 14 billion 10-milligram pills. That is right. Today the Drug Enforcement Administration is telling Big Pharma it is OK to make 14 billion OxyContin pills to sell in the United States in 1 year.

The Federal Food and Drug Administration was also complicit, approving new opioid after new opioid. In the process, the FDA, charged with ensuring the safety of all prescription drugs on the U.S. market, began turning a blind eye to outside experts who were warning of the dangers these drugs posed.

In 2013, 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.

In 2014, in the wake of the Zohydro decision, the FDA twice skipped the advisory committee process altogether when it approved two new prescription opioids.

Then, in August of 2015, the FDA did it again. This time it bypassed an advisory committee of outside experts on the question of a new use for OxyContin for children aged 11 to 16. The FDA even ignored its own rules that specifically call for advisory committee advice when a committee of pediatric dosing is involved. It was clear that the FDA was intentionally choosing to forgo advisory committees in order to avoid another overwhelming Zohydro-like vote, recommending against approval of a prescription opioid and in order to avoid any impediments to new opioids being sold in the United States.

Finally, the medical profession must bear its fair share of responsibility for this crisis. Doctors are prescribing opioids at an alarming rate. In 2012, America's doctors wrote 259 million prescriptions for opioid pain relievers, enough pills for every single American adult to have a bottle of opioid pills given to them in the year 2012.

And America's doctors are dangerously uninformed about the drugs they are prescribing. A recent survey of 1,000 physicians nationwide found that ``only two-thirds correctly reported that the most common route of abuse was swallowing pills whole.'' It is unconscionable that our doctors are so ill-informed. Nearly half of the doctors surveyed also erroneously reported that so-called abuse-deterrent formulations of opioids were less addictive than their counterparts. Abuse-deterrent opioids are supposed to be harder to crush, so they are harder to snort or to mix with liquid and inject, but abuse-deterrent formulations of opioids are just as addictive as non-abuse-deterrent opioids. Whether an opioid is abuse-deterrent or not hasn't prevented tens of thousands of people who have had their wisdom teeth removed or experienced lower back pain from getting addicted to these painkillers simply by swallowing them.

So what is the result of the combination of Big Pharma's marketing of prescription opioids, the Federal Government's repeatedly approving them in ever-increasing numbers, and our doctors writing millions of prescriptions for them? Today, the United States is less than 5 percent of the world's population but we consume 80 percent of the world's opioid painkillers. We have become the United States of Oxy.

When prescriptions run out or the price of Oxy pills on the street become too high for those who have become addicted, they turn to cheaper heroin, which shares the same molecular structure as OxyContin. Eighty percent of the people suffering from heroin addiction started with opioid pain medications approved by the FDA and prescribed by doctors.

In 2014, nearly 33,000 people died of an opioid overdose in this country. Almost 1,300 of those deaths were in my home State of Massachusetts.

I had hoped to offer amendments to CARA to address both the causes of this epidemic and to provide treatment for those suffering from the results. One of my amendments would have required the FDA to convene advisory committees for all prescription opioid approval questions.

After I placed a hold on the nomination of Dr. Robert Califf to serve as FDA Commissioner, the agency announced it would only commit to convene advisory committees for non-abuse-deterrent opioids. The FDA refused to agree to convene advisory committees to inform all of its opioid-approval decisions.

We need legislation requiring the FDA to seek expert advice about the risk of addiction before it approves any and all opioids, and I will continue to fight to require advisory committees at the FDA.

We also need legislation requiring doctors to get and stay educated about the dangers of the pills they are prescribing in record numbers. Stopping the overprescription of opioid painkillers is a critical step.

We need to ensure that all prescribers of these opioid painkillers are educated in the dangers of these drugs, how easily individuals can become addicted, and when and how to appropriately prescribe. The doctors say that they do not want education to be mandated, that it should be voluntary. Well, the FDA has had voluntary education for opioid prescribers in place since 2013 and has been actively encouraging doctors to take these voluntary education programs, but in more than 2 years, only 12 percent of prescribers have actually completed FDA's voluntary education program.

It is imperative that any provider who is applying for a Federal DEA license to prescribe opioids have completed mandatory education on the basics of opioid prescribing and the inherent risk of addiction. My amendment would have done just that. It would have required basic education as a condition of a DEA license to prescribe these painkillers, and I will continue to fight to require prescriber education.

Finally, we need to remove the barriers to effective treatment, including outdated Federal restrictions on medication-assisted therapies such as Suboxone. Medication-assisted therapy for opioid addiction is cost effective, decreases overdose deaths, and reduces transmission of HIV and hepatitis C. Unlike other treatment regimens for any other disease, physicians are severely limited in the number of patients they can treat with medication-assisted therapies such as Suboxone, contributing to long wait-lists and an inability of patients to get treatment for their addiction when they need it. Of approximately 2.5 million Americans who abused or were dependent on opioids, fewer than 1 million received treatment for their condition, partly because of the already existing Federal instructions.

Senator Rand Paul of Kentucky and I have a bipartisan bill, the Recovery Enhancement for Addiction Treatment Act, or TREAT Act, which has broad stakeholder support, including the American Medical Association and nurse practitioners. It emphasizes quality of care and closes this gaping hole in our addiction treatment system. We had hoped to offer TREAT as an amendment to CARA. We will continue to fight for it and are hopeful the HELP Committee will include it in the substance abuse legislation the committee will soon consider.

My collaboration with Senator Paul shows that whether it is the Commonwealth of Massachusetts or the Commonwealth of Kentucky, this crisis is the same. It doesn't discriminate by geography, by age, by race, by socioeconomic status, or by employment. It requires a bipartisan effort.

Thirty years ago, Nancy Reagan told us to just say no to drugs. Today we have to go further. We have to say enough is enough. We have to recognize what has worked and what hasn't worked. In the past, we believed we could incarcerate our way out of the problem. That did not work. So instead of ignoring and incarcerating, let's avow and act. Let's destigmatize, not criminalize. Let's treat, not retreat. Let's have a comprehensive plan which we put in place that deals with the pharmaceutical companies, the physicians, and the kinds of treatment patients need across our country so that they get the help they need. That is our job.

I continue to believe we can do this in a bipartisan fashion as long as we understand the magnitude of the problem and what the causes of it were and continue to be and will be into the future unless and until we put these safeguards in place. So I am looking forward to continuing to work with my colleagues on the other side of the aisle. I compliment them for the work they have done so far in bringing this bill to the floor of the Senate this week, but I do believe there is more to be done.

As long as this many Americans are addicted, as long as this much OxyContin and opioids are put into our system, then we are going to find that this heroin epidemic we have in our country, which is directly related, will continue to spiral out of control.

I want to work with all my colleagues. I thank my colleagues for all the work they have done so far, but there is much work to be done in the future.

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