Nomination of Robert Califf

Floor Speech

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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 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.

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