[Congressional Record Volume 168, Number 30 (Tuesday, February 15, 2022)]
[Senate]
[Pages S687-S688]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                  Nomination of Robert McKinnon Califf

  Mr. DAINES. Mr. President, I rise in opposition to the Biden 
administration's nomination of Robert Califf to be the FDA 
Commissioner.
  As FDA Commissioner during the Obama administration, Mr. Califf 
showed blatant disregard for the unborn and for the health and safety 
of women and girls when he weakened safety and reporting requirements 
for a dangerous chemical abortion drug.
  In fact, this past December, the Biden administration went further 
and announced it would eliminate entirely the in-person dispensing 
requirement for the abortion drug. This very reckless decision promotes 
mail order, do-it-yourself abortion-on-demand and disregards the 
growing threat to women's health posed by chemical abortion drugs. For 
example, without physician in-person screening, women are denied the 
opportunity to be screened for dangerous conditions like ectopic 
pregnancies, which can cause life-threatening complications.
  Mr. Califf has refused to distance himself from the FDA's decision to 
abandon vulnerable pregnant women to the reckless and predatory actions 
of the abortion industry. Mr. Califf has a track record of putting an 
extreme abortion agenda above the science.
  The nomination of Robert Califf to be FDA Commissioner endangers the 
well-being of unborn babies, women, and girls, and I urge my colleagues 
to join me in opposing his nomination.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from North Carolina.
  Mr. BURR. Mr. President, I actually rise today to support Bob Califf 
and to say to my colleagues there has been a lot of criticism as to 
what he has done. I have never seen an FDA Commissioner, in 9 months of 
service--that was the length of his time at the FDA--who accomplished 
anything, much less as many negatives as have been raised.
  But as the ranking member of the HELP Committee and as a fellow North 
Carolinian, I would like to share with my colleagues that Dr. Califf is 
a supremely qualified nominee with bipartisan support. He has the 
robust agency and private sector experience needed to help build on the 
success of the FDA in helping Americans get back to normal life with 
the approval of tests, vaccines, and therapeutics that are bringing the 
pandemic to an end.
  He is the leader we need today but also for the future. Now, let me 
take a few moments to explain why.
  It has been 391 days since the FDA has had a Senate-confirmed 
Commissioner--391 days. No matter how effective and successful an 
Acting Commissioner can be--and we have been blessed with Janet 
Woodcock's leadership--the full backing of a Presidential nomination 
and confirmation by the U.S. Senate carry a weight that allows a 
confirmed Commissioner to push forward necessary, meaningful change and 
leadership within a Federal Agency.
  There has never been a more critical time for the FDA to have 
effective leadership. While the FDA has long played a leading role in 
the lives of the American people, regulating 20 cents of every dollar 
of the U.S. economy, the COVID pandemic brought the actions of the FDA 
during the response to the dinner-table conversation of every family in 
this country.
  In the 391 days since our last confirmed Commissioner stepped down, 
there have been two new, serious variants of the COVID virus; case 
counts that topped 1 million per day; shortages of vital therapeutics 
and diagnostic tests; and, tragically, the loss of hundreds of 
thousands of American lives. The FDA has and will continue to play a 
leading role in our response to a once-in-a-century pandemic.

  The Agency's unprecedented work helped innovators bring forward 
countermeasures, tests, treatments, and vaccines that have helped us 
withstand and fight against the virus and instill hope in Americans in 
some of the darkest moments of the pandemic. The FDA has made 
significant progress to advance medical product development.
  As new cases continue to slow and spring approaches, we are at what I 
am hopeful is an inflection point. Mask mandates are lifting, children 
are back in school, and the FDA is ready to move into the next phase of 
the response that will hopefully bring us back to normal. The FDA needs 
a leader who will not lose sight of the progress it has made.
  The silver lining of COVID has been its ability to show the value of 
American innovation and ingenuity. No one understands that better than 
Dr. Califf. His expertise at translational science means that he 
understands what it takes to transform an idea from a research bench 
into a real solution for patients.
  COVID catalyzed the FDA and the private sector to compress the 
timeline of the transformation without--without--sacrificing our world-
renowned gold standard for safe and effective

[[Page S688]]

medical products. Platform technologies were developed through programs 
like Operation Warp Speed and RADx that put us leaps and bounds ahead. 
These types of technologies are force multipliers, allowing us to bring 
new options to patients with cancer, infectious diseases, and life-
threatening conditions by adapting the same underlying technology. We 
need a Commissioner who understands and will advance these 
breakthroughs.
  I urge my colleagues, support Dr. Califf's nomination because he will 
provide the leadership needed to promote today's biomedical 
advancements and help to pave the way for tomorrow's innovation.
  As many know, I have been one of the FDA's toughest critics over the 
years. However, I am critical because I believe in the Agency's 
mission, and I know that American patients pay the price if the FDA 
falls behind.
  The FDA has an opportunity to be forever changed for the better, but 
it needs effective leadership to get there. Dr. Califf knows the Agency 
well, understands the value of innovation underway in academia, and 
knows firsthand how the private sector is advancing cutting-edge 
science that can benefit all Americans.
  I urge my colleagues this morning to support the nomination of Robert 
Califf.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from West Virginia.
  Mr. MANCHIN. Mr. President, I rise in opposition to Dr. Califf, and I 
have spoken before on this. I just want to say this for a minute or two 
here.
  I respect everyone's position on this and their decision, but I have 
never had anything that has affected my State and constituents in my 
State and our country more than the opioid addiction.
  This opioid addiction started because of the FDA's decision to bring 
a product to market in 1995 that has destroyed many families, many 
communities, many businesses, people's lives forever. In story after 
story--there is not a Senator in this body who doesn't have someone in 
their family, immediate family or extended family, or a constituent who 
hasn't been affected.
  With that, you need to change the dynamics of the leadership over 
there. Dr. Califf was there 5 years ago. He is coming back. Nothing has 
changed. Four hundred thousand people have died since he was there, and 
we are going down the same path.
  Unless we change that dynamic, that leadership position on trying to 
protect the people of America without putting more and more horrible 
drugs on the market--there was one drug back in, I think it was 2014, 
2013 or 2014, called Zohydro, and the advisory committee recommended 11 
to 2: Do not bring this drug to market. They did it anyway. It was 11 
to 2, don't do it. These are experts. They said two pills can kill a 
human being. They brought it continuously. They continue to bring more 
opiates to the market.

  We don't need this product on the market to kill more Americans. This 
Administration, under Robert Califf, will take the same old, same old 
as they did before. Nothing will change.
  I urge all of my colleagues, please consider what you are doing. 
Consider your family and your constituents and please vote against 
Robert Califf.
  The PRESIDING OFFICER. The Senator from Washington.
  Mrs. MURRAY. Mr. President, I ask unanimous consent to speak for 1 
minute before the vote.
  The PRESIDING OFFICER. Without objection.
  Mrs. MURRAY. Mr. President, I urge all of my colleagues to give 
families across the country the peace of mind and give the hard-working 
staff at the FDA the experienced, Senate-confirmed leadership it needs 
by joining me in confirming Dr. Califf today and working with him and 
FDA to continue protecting families across our country, upholding the 
gold standard of safety and effectiveness, and putting science and data 
first.
  We previously confirmed Dr. Califf in this role in a bipartisan way, 
and we recently advanced his nomination out of the HELP Committee with 
bipartisan support. So I hope today, once again, this qualified 
nomination passes with the bipartisan support it deserves.
  I yield the floor.

                          ____________________