April 9, 2019 - Issue: Vol. 165, No. 61 — Daily Edition116th Congress (2019 - 2020) - 1st Session

[Pages S2321-S2322]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                     TRIBUTE TO DR. SCOTT GOTTLIEB

  Mr. ALEXANDER. Madam President, nearly two years ago, just before the 
Senate voted to confirm Dr. Gottlieb to lead the Food and Drug 
Administration, FDA, I said that he was ``the right person to lead the 
FDA in [its] vital mission and move the agency forward so that 
America's patients can benefit from the remarkable discoveries . . . 
that our nation's researchers are working on.''
  Since then, Dr. Gottlieb's leadership at FDA has proved that 
prediction correct.
  Dr. Gottlieb has been one of the President's best appointments.
  Two years ago, I also said that ``there's never been a more important 
time to capitalize on the significant funding Congress has given to 
medical research.''
  Congress has given the National Institutes of Health, NIH, a $9 
billion increase from 2015-2019, almost $40 billion dollars in 2019, 
and FDA plays a key role in bringing new treatments and cures to 
American patients.
  In 2016, Congress passed what Leader McConnell called the most 
important legislation of the Congress, the 21st Century Cures Act, to 
help speed the development of new drugs and devices.
  This exciting time in medicine also brings great promise to patients 
to lower the cost of medicine, as more promising treatments come to 
market, we see increased competition, which helps to drive down how 
much patients pay for medicines they need.
  Dr. Gottlieb's successful tenure at the agency includes helping to 
bring more competition to the market. In 2018, FDA approved or 
tentatively approved over 1,000 generic drugs, approved 34 novel orphan 
drugs, which are drugs to treat rare diseases, and designated 18 
regenerative medicines as regenerative medicine advanced therapies, so 
they can be reviewed faster.
  Here are just a few other important things Dr. Gottlieb has 
accomplished:
  When Dr. Gottlieb took over at FDA, Congress was working to 
reauthorize the four medical product user fee agreements that make up 
about a third of FDA's funding.
  In addition to reauthorizing the four user fee agreements, Congress 
worked with Dr. Gottlieb and authorized an expedited approval process 
for generic

[[Page S2322]]

drugs where there is little or no market competition, called the 
Competitive Generic Therapies pathway, as part of the FDA 
Reauthorization Act of 2017.
  Since August 2018, FDA has approved five new generic drugs under this 
pathway and has designated over 140 generic drug applications as 
qualifying for this pathway.
  Dr. Gottlieb also announced a new plan, called the Biosimilar Action 
Plan, to bring generic versions of biologic drugs, called biosimilars, 
to help improve competition for biologics by increasing market entry of 
biosimilars and providing more treatment options for patients.
  FDA has approved a total of 18 biosimilar products since 2010, when 
the biosimilar pathway was created, 13 of which were approved under Dr. 
Gottlieb's watch.
  At his confirmation hearing, Dr. Gottlieb described the opioid crisis 
as ``having staggering human consequences. I think it's the biggest 
crisis facing the agency. . . . I think it's going to require an all-
of-the-above approach . . .''
  Last year, 72 senators worked on legislation to combat the opioid 
crisis.
  Dr. Gottlieb provided us with crucial advice as we worked on this 
legislation and has begun to take advantage of the new law.
  He has taken steps to help prevent illicit fentanyl, which is 100 
times more powerful than heroin, from coming across the border.
  He worked with Congress to clarify his authority to require opioids 
to be packaged in blister packs, such as a 3 or 7-day supply, to 
encourage doctors to prescribe responsibly; and clarified FDA's 
authority to require safe disposal options to accompany opioid 
packaging.
  Dr. Collins, who leads the NIH, has predicted a nonaddictive opioid 
in the next decade, which really is the Holy Grail for fighting the 
opioid crisis and for helping the 50-100 million Americans living with 
pain.
  I believe Dr. Gottlieb has laid groundwork to encourage the 
development of nonaddictive and nonopioid medicines and therapies to 
treat pain.
  Dr. Gottlieb was integral to Congress's ability to reauthorize the 
animal drug user fees, which authorize the FDA to collect user fees to 
speed the review and approval of new drugs that farmers, families, and 
veterinarians rely on to keep their animals healthy and the food supply 
safe.
  The 21st Century Cures Act created the Regenerative Medicine Advanced 
Therapy Designation, which is similar to the very successful 
breakthrough drug pathway that safely shortened the development and 
review time for certain drugs, to get them to patients who need them 
more quickly.
  While we worked on that law, I heard the story of Nashville resident 
Doug Oliver.
  In 2007, Doug began to have trouble seeing and, after a near 
accident, had his driver's license taken away and was declared legally 
blind.
  The culprit was a rare form of macular degeneration.
  His doctor at the Vanderbilt Eye Institute told him that while there 
were no cures, Doug could search online for a clinical trial.
  Doug found a regenerative medicine clinical trial in Florida, where 
doctors took cells out of the bone marrow in his hip, spun them in a 
centrifuge, and then injected those into his eye.
  Three days later, he began to see.
  His eyesight eventually improved enough to get his driver's license 
back, and he became an effective advocate for more support for 
regenerative medicine, which we included in the 21st Century Cures Act.
  So, with his improved vision, he began writing letters and visiting 
me to advocate for more support for regenerative medicine, which we did 
in the 21st Century Cures Act.
  Two years ago, Doug gave me the cane he had used while he was blind. 
He said: ``I don't need it anymore.''
  In Cures, we included a pathway to bring new regenerative medicine 
treatments, similar to the treatment Doug received, to patients more 
quickly.
  Dr. Gottlieb has worked to implement that new pathway to help develop 
safe treatments to ensure more patients are able to take advantage of 
this cutting-edge, personalized medical technology.
  Additionally, Dr. Gottlieb has helped the agency develop and advance 
guidances for gene therapies that will help new innovative companies 
developing these promising therapies, some of which may be for specific 
diseases and conditions that provide roadmaps for biotechnology 
companies who are leading the way in precision medicine.
  During this exciting time in biomedical research, we are fortunate 
that Dr. Gottlieb was willing to serve.
  The FDA and the biomedical community is in better shape today to 
advance medical innovation and develop the treatments and cures of the 
future because of his leadership.

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