Nomination of Robert Califf

Floor Speech

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Mr. BLUMENTHAL. Madam President, I am so honored to follow my great friend and very eloquent advocate from Massachusetts, Senator Markey, who said much more powerfully than I can our reasons for opposing Dr. Robert Califf as the nominee for the head of the FDA. To say it very simply, this agency needs drastic reform. It needs an overhaul in the way that it approves these powerful painkilling substances that can be a gateway to addiction, whether to opiates or whether to heroin. I am proud to stand on the floor with Senator Markey, Senator Manchin, and others who feel that more must be done, that our Nation is lagging in addressing an epidemic.

It is truly a public health hurricane that is sweeping Connecticut and our country. I have done roundtables around my State that are among the most moving public experiences of my service in the Senate and, indeed, my time for 20 years as attorney general on any public issue. It is an issue that concerns Iowa as well as every other State in the country. It is an issue that should bring us together on a bipartisan basis to address this true public health crisis.

My reason for opposing Dr. Califf is, very simply, the failure of the FDA to recognize its own shortcomings and the prospect that there will be no change in the way the FDA is responding or failing to respond to this crisis if he is confirmed. With his confirmation, all that we can see ahead is more of the same.

That is unacceptable. The FDA must be part of the solution or it will continue to be part of the problem. There is no question that the solution to this problem has to be multifaceted. In the roundtables that I have held around our State and in my conversations with the experts in this field and in the meetings that I have conducted with public health officials around the State with recovering addicts and their families, law enforcement, as well as public officials, I have seen that there is no single solution. There is no one-size-fits-all for recovering addicts, for communities, for different parts of the country. There has to be an emphasis on law enforcement because cutting off the supply has to be an objective, and law enforcement needs and deserves more support from this Nation and from the Congress. There has to be an emphasis on treatment and services. We are not going to arrest our way or jail our way out of this public health crisis, nor is treatment alone a sufficient solution. Part of the solution has to be more action from the FDA to oversee, scrutinize, and stop the pipeline of painkillers and opioids that are continuing to deluge our community.

The urgency of this crisis is clear. In 2015 my State had more than 700 prescriptions leading to overdose deaths. These fatal overdoses are also avoidable. The number of opioid-related deaths around the Nation has skyrocketed, and behind every one of these heartbroken families and communities is a realization that more must be done. We depend on the FDA to deal with these kinds of problems. The American people rely on this agency to implement a strong, regulatory approach to protect them.

Unfortunately, the FDA has utterly and abjectly failed to protect the American people against the epidemic of opioid overuse. The FDA has a troubling history in this area, and I am well familiar with it because I highlighted it when I was the attorney general of our State, asking for stronger warnings for patients and consumers, asking for better oversight of oxycodone and related medicine, and asking for better supervision and education of the prescribers. And I asked in letters, in petitions, and in legal actions. In effect, the FDA has fueled this crisis by approving too many drugs with too little analysis. Too often, it has failed to use an advisory committee when approving a new opioid painkiller. It has demonstrated a troubling preference for speed over safety. It has expedited consideration at the risk of public health.

It is essential to have an independent panel of experts to review and advise the agency on its approval of any opioid painkiller, giving the public a chance to provide input before a product comes to market. Unfortunately, in addition to instances where no advisory committee has been convened, the FDA has simply approved new drugs over committees objections. This failing to listen to warnings from experts harms public health and safety and confidence and credibility of this agency.

One example, which some of my colleagues may remember, concerns the FDA's approval of the drug Zohydro. This high-dose, extremely potent opioid, which lacks abuse-deterrent properties, was approved in 2014 despite strong objections from the scientific advisory panel that approved it. That panel voted 11 to 2 against approving the drug.

The questionable oversight tactics the FDA has employed so far leave me with serious doubts about its ability to implement its recently released action plan. In this plan, the agency committed to convening advisory committees when approving any opioid painkiller that is not abuse-deterrent. This approach is, very simply, insufficient.

We have seen how dangerous opioids can be. All opioids, whether or not they are classified as abuse-deterrent, should be reviewed by an independent advisory committee. And even if an opioid is classified as abuse-deterrent, that doesn't mean it cannot be abused or that an advisory committee shouldn't be consulted. The FDA itself recognizes that abuse-deterrent technology is in its infancy and independent advice is therefore essential.

Unfortunately, instances where the FDA has failed to listen to its advisory committees are not limited to the context of drug approvals. In 2012 the agency recognized that opioids could lead to a number of dangerous outcomes--addiction, accidental overdose, and death. In response, the FDA implemented a risk-management strategy for extended- release opioids, including requiring education for prescribers on safe prescription practices and the potential for abuse and addiction. Two years have passed--2 years since the first of these trainings was made available--but the FDA has yet to release information showing how many prescribers have been trained and educated on responsible prescribing practices. The FDA has ignored my call for this information to be released.

The FDA has ignored the recommendations from two advisory committees that a similar strategy should be used for immediate-release opioids as well--a crucial issue, given that 91 percent of all opioids prescribed are in this category.

I urge my colleagues to join with me in sending a signal to the FDA that more effective scrutiny and actions are vitally important. The FDA has failed to take this crisis seriously. Until it does, it is failing the American people. And a new FDA head must indicate there will be a sea change--a fundamental overhaul--in the way FDA oversees and protects the American people.

I would like to highlight as well the crucial importance of finalizing the deeming rule, which is necessary to ensure the agency's authority over all tobacco products--also pertaining to addiction; the drug is nicotine--and that is essential to ensure that not only cigarettes but also e-cigarettes--that the companies that make them cannot market to children and to people who may be led to addiction to that drug.

I am determined that the Nation do better in addressing this urgent crisis--a public health hurricane sweeping this country, as disastrous as any physical crisis of tornadoes or floods, maybe, in destroying lives and jeopardizing our national security.

I am pleased to yield back to my colleague Senator Markey and to be joined by my great friend and colleague Senator Joe Manchin of West Virginia.

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