[Congressional Record (Bound Edition), Volume 163 (2017), Part 6]
[Senate]
[Page 7639]
[From the U.S. Government Publishing Office, www.gpo.gov]




                      NOMINATION OF SCOTT GOTTLIEB

  Mr. McCONNELL. Mr. President, the heroin and prescription opioid 
epidemic is taking a heartbreaking toll on families and communities 
across our country. Experts estimate that as many as 2 million 
Americans are struggling with prescription drug addiction, with heroin 
and opioid overdoses claiming an average of 91 lives every day.
  We continue to read the devastating headlines, too, like one article 
published by CNN entitled ``A Generation of Heroin Orphans.'' It told 
the story of five Kentucky children living with their grandparents due 
to their mother's addiction. Sadly, this family is not unique. Nearly 3 
million grandparents or other relatives across the country are caring 
for grandchildren. According to experts, this uptick in children left 
without their parents is due, at least in part, to this epidemic. It is 
one of the many reasons the heroin and prescription opioid crisis 
requires continued action.
  Americans across the country--law enforcement, nurses, family 
members, and many others--have dedicated themselves to reversing this 
crisis. Congress has taken significant steps to combat this growing 
problem on a bipartisan basis. Through legislation like the 
Comprehensive Addiction and Recovery Act, CARA, and the 21st century 
cures bill, we authorized important ways to help fight the opioid 
epidemic through things like expanded education and prevention 
initiatives, improved treatment programs, and we bolstered law 
enforcement efforts. Implementation of these initiatives is already 
helping to tackle this crisis.
  I was proud to support these pieces of legislation because I knew 
they could make a real impact in the fight against opioid abuse, and 
they are. We were able to take another positive step just last week. 
Congress passed an important piece of funding legislation, now law, 
that is helping advance and support many of the programs Congress 
authorized in CARA and the 21st century cures bill last year--programs 
that can advance medical innovation and promote research and treatment 
development.
  That funding legislation dedicated significant new resources to the 
fight against the opioid epidemic. It helped fund groundbreaking 
research into the field of regenerative medicine. With its passage, 
Congress took one more critical step forward in the advancement of 
medical research and addiction treatment.
  The Senate will soon have another opportunity to move ahead in the 
fight against this devastating disease by voting to confirm Dr. Scott 
Gottlieb to oversee the Food and Drug Administration.
  The FDA plays a central role in the approval of new drug treatments 
and therapies. An important part of the 21st Century Cures Act provided 
an accelerated pathway for the FDA to approve regenerative medicines. I 
look forward to having a Commissioner like Dr. Gottlieb, who is 
committed to the development of groundbreaking medicines and treatments 
to combat serious illnesses.
  Additionally, the FDA will continue to be a crucial partner as States 
like Kentucky continue their fight against the opioid epidemic. The FDA 
plays an important regulatory and oversight role in combating this 
crisis.
  I have encouraged the agency to incentivize the approval of safer, 
more abuse-deterrent formulations of drugs, and I am glad when they 
have concurred. These types of constructive policy decisions show an 
FDA that is ready to join the fight against heartbreaking disease and 
opioid abuse, and I am proud to support that kind of rigorous oversight 
from the agency.
  Dr. Gottlieb has the necessary experience to serve in this key role. 
Not only has he worked in hospitals, interacting directly with those 
affected by disease and treatment, but he has also developed and 
analyzed medical policies in both the public and private sectors. He 
formed his perspectives on the dynamic public health sector by 
overseeing medical research and innovation projects.
  In 2005, Dr. Gottlieb was appointed the FDA's Deputy Commissioner for 
Medical and Scientific Affairs. He also has served as senior adviser to 
the FDA Commissioner and as the agency's Director of Medical Policy 
Development.
  As a practicing physician with a wealth of policy experience, Dr. 
Gottlieb has the necessary qualifications to lead the FDA at this 
critical time. The Senate voted to advance his nomination last night on 
a bipartisan basis, and I look forward to his confirmation.

                          ____________________