Prescription Drug Addiction

Floor Speech

BREAK IN TRANSCRIPT

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.
BREAK IN TRANSCRIPT

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 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.

BREAK IN TRANSCRIPT

Source