Nomination of Robert McKinnon Califf

Floor Speech

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Mr. MARKEY. Mr. President, I rise today to speak in opposition to the nomination of Dr. Robert Califf to lead the Food and Drug Administration.

For more than two decades now, the United States has suffered a devastating epidemic of opioid use disorder, overdoses, and deaths. Since 1999, almost 1 million Americans have died of drug overdoses, with the vast majority of those deaths attributable to opioids.

As our country continues to deal with the COVID-19 pandemic, we must remember and prioritize this other deadly public health emergency.

In 2020, overall drug overdose deaths reached an alltime high for the year, with approximately 93,000 Americans losing their lives. More than 60 percent of those deaths were from synthetic opioids like fentanyl. That is a staggering 69,000 Americans dead from an opioid-related overdose--more than gun violence, more than car accidents, more overdose deaths than ever before in our history.

We cannot let the tragedy of COVID-19 overwhelm the daily suffering of the opioid epidemic. Sadly, for the scourge of opioid misuse and overdose in our country, there is no vaccine.

My home State has been hit especially hard. In Massachusetts, more than 2,100 residents died from an opioid overdose in 2020--a 5-percent increase from the previous year--and many more struggled with opioid use disorder. Early data from 2021 shows this unfortunate trend continued through the first 9 months of last year, where 1,613 people died in Massachusetts from opioid overdoses.

We cite these numbers with outrage and disbelief, but for impacted families and loved ones, it is an ever-present mourning for lost opportunities, futures gone too soon, and unanswered questions; all the while, for each and every community, there is the growing challenge still to be addressed.

In Congress, my colleagues and I have worked to respond to this crisis, passing several bipartisan packages--the Comprehensive Addiction and Recovery Act, CARA, and the SUPPORT Act to help bring relief to our communities.

I am proud several pieces of legislation I authored to fund and expand opioid use disorder prevention and treatment programs became law in those packages. Those investments are important, and we must continue to build on them, but we cannot forget how we reached this epidemic in the first place or we are doomed to repeat it for those families.

Those failures started at Big Pharma and were aided and abetted by the Food and Drug Administration. The FDA is supposed to be our Nation's pharmaceutical gatekeeper, but over many years, it repeatedly rubberstamped new prescription painkillers that increased the risk of misuse and dependence.

As evidence of the deadly harm those opioids caused became clear, the FDA did almost nothing. It acted too slowly to remove them from the market, to limit access to those supercharged opioids.

What started as an OxyContin prescription for back pain became full- blown dependence on heroin for countless Americans. Even well into the crisis, the FDA continued to approve powerful new opioids, either over the express objections of its own advisory committees or without convening an advisory committee at all. The FDA became the country's biggest pill pusher, and Big Pharma made billions in profits.

The Nation's pharmaceutical watchdog became the Nation's pharmaceutical lapdog, and the country became the ``United States of Oxy.'' I consistently raised concerns about the FDA's egregious mishandling of opioid approvals when Dr. Califf was first nominated to be Commissioner in 2015.

At that time, I opposed Dr. Califf's nomination until the Agency took steps to rescind approval for pediatric OxyContin--yes, OxyContin for kids. I demanded the FDA commit to impanel advisory committees for all opioid regulatory decisions and consider public health factors in opioid regulatory decisions, in particular the impact of new opioids on opioid misuse and dependence.

When the FDA did attempt to address its failures in regulating opioids after strong criticism from me and many of my colleagues, Dr. Califf and Dr. Janet Woodcock requested a National Academy of Sciences study of FDA's policies for evaluating opioids--not a major step but at least an effort to recognize its participation in the epidemic.

That study emphasized many of the efforts which I urged Dr. Califf and the FDA to undertake back in 2015; in particular, the need to include public health factors at every level of FDA regulation of opioid drugs. But to date, the FDA still has not implemented many of those recommendations. And where it has taken steps to do so, it has not gone far enough to address its past failures.

There was no real commitment to reforming the FDA or to learning from the mistakes that enabled this public health crisis.

At this point, the opioid epidemic has evolved from being driven by prescription drugs to being fueled by the illicit synthetic opioids, like fentanyl. But that does not dismiss the FDA from accountability or the need for reform.

When I met with Dr. Califf last year, I asked him to commit, if confirmed as FDA Commissioner, to finally change FDA's processes to ensure it does not make the opioid overdose epidemic worse than it already has. During our meeting, Dr. Califf did not commit to the decisive and comprehensive action which we need.

After years of Agency failures and in the midst of a worsening opioid epidemic, we need FDA leadership that is fully committed to using all of the Agency's oversight authority to protect public health.

I cannot support Dr. Califf's nomination in light of that critical mandate which we need. We need a leader at the FDA who will center public health and implement reforms to its review of opioids.

And, specifically, we need the FDA to conduct a full, comprehensive review of approved opioids as the National Academy of Sciences study recommends. We need to finalize strong rules for opioid approvals that require analysis of the impact of new drugs on opioid dependency and misuse. And the FDA needs to be aggressive in mitigating the risks of approved opioids by requiring robust prescriber education on opioids and performing regular, formal reviews of approved opioids.

These are not all the steps that must be taken, but with these, we can at least be sure that we are on the road to opioid misuse disorder reform; that there won't be another FDA green light in front of it.

Here in the Senate we must also commit to doing more to addressing the opioid overdose epidemic. Prescription opioid medications still lack a clear, concise, and consistent warning label informing patients of the risks of the drug for dependence and misuse.

Some physicians still lack the education and tools necessary to identify and help patients with substance use disorders. And, critically, treatment remains inaccessible and stigmatized for many people in need, especially those ensnared in the criminal justice system.

We have to pass legislation to address these concerns, and I stand ready to work with my colleagues. I recently introduced legislation with Senator Rand Paul that would modernize the outdated and burdensome Federal regulations on methadone, one of the most effective forms of treatment for opioid use disorder.

We can do a lot. And working with Senator Cotton, I worked to promulgate and now we need to implement the recommendations of the Commission on Combating Synthetic Opioids Trafficking, and we need to do that this year.

We need leaders in all branches of the Federal Government to bring this aggressive, intentional approach to their work, if we have any hope of ending the epidemic of opioid overdose deaths.

Dr. Califf is simply not that person for the FDA, and I will vote no on his nomination.

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