[Congressional Record Volume 168, Number 30 (Tuesday, February 15, 2022)]
[Senate]
[Pages S685-S686]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                  Nomination of Robert McKinnon Califf

  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

[[Page S686]]

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.
  The PRESIDING OFFICER. The Senator from Virginia.