[Congressional Record Volume 166, Number 47 (Wednesday, March 11, 2020)]
[Senate]
[Pages S1698-S1699]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                              CORONAVIRUS

  Mrs. BLACKBURN. Mr. President, I will have to tell you and all of my 
colleagues, as they probably know, this has been a fairly tough month 
for my fellow Tennesseans.
  As you know, last week, a tornado tore through eight counties. This 
started in West Tennessee and exited through Middle Tennessee up on the 
plateau of our great State. This left multiple communities absolutely 
devastated. We have mourned the loss of life and livelihoods and 
property.
  I want to, again, thank President Trump for coming to Tennessee to 
offer his support and for listening to those who were so adversely 
impacted by this storm and for being there to encourage the emergency 
management officials, the volunteers, and all of the elected community 
officials.
  We have been encouraged that our Tennesseans have been joined from 
volunteers all across the country who have shown up to help. They have 
donated their time, their supplies, and their money to our restoration 
and rebuilding and recovery and cleanup efforts. To all of those who 
have volunteered and offered their support, you have made such a 
difference in the lives of so many Tennessee families. We know this is 
going to be a long and difficult recovery.
  After all of this occurred, on Wednesday of last week, Tennessee 
health officials confirmed our first case of coronavirus. It was in a 
patient just south of Nashville in Williamson County.
  With all that said, that is a lot to handle in any given week, but 
Tennesseans and all Americans should be encouraged that there is a lot 
of good work that is taking place. As I said, the rebuilding efforts 
span all of those counties in our State.
  And then, of course, right there in Nashville are efforts to combat 
the spread of the 2019 novel coronavirus. The Vanderbilt University 
Medical Center's Denison Lab is one of the top 20 labs in the world 
that is studying this disease. For over 25 years, they received Federal 
grants for their research into how these viruses make us sick, and they 
are currently helping with the development of treatments, anti-virals, 
and vaccines to deal with coronaviruses, and especially the COVID-19. I 
am just so pleased with the progress they are making.
  Today I want to draw attention to a threat that has, again, been 
highlighted because of this coronavirus outbreak. Pharmaceuticals are 
no different from other products in that they

[[Page S1699]]

are usually manufactured in pieces--the active ingredients in one place 
and the inactive ingredients in another place and so on. Currently, 
only 28 percent of the facilities producing active pharmaceutical 
ingredients--and you will hear these referred to by the acronym APIs--
only 28 percent of the facilities producing these APIs are in the 
United States. What this means is that American consumers rely heavily 
on foreign-sourced drugs in order to stay healthy.
  Meanwhile, the number of Chinese facilities producing these APIs has 
more than doubled since 2010. Think about that. Only 28 percent of all 
the facilities globally are in the United States. China has doubled the 
number of facilities in China that are producing these APIs.
  Why does this matter? Last year, experts at the FDA testified before 
Congress that while the United States is a world leader in drug 
development, we are falling behind in drug manufacturing. We do all the 
R&D here. We have the great scientific minds here. They are creating 
these products. They are manufactured primarily in China. Their 
testimony identified the cessation of American manufacturing of APIs as 
a key health and security concern because it created vulnerabilities in 
the U.S. supply chain.
  The FDA is not alone in their concerns. In its 2019 report to 
Congress, the U.S.-China Economic and Security Review Commission 
revealed ``serious deficiencies in health and safety standards in 
China's pharmaceutical sector.'' That is not something that somebody 
just read on the internet. It is not an assumption. That is the 2019 
report to Congress from the U.S.-China Economic and Security Review.

  The coronavirus outbreak is drawing much needed attention to the 
possibility of a global health crisis. Indeed, today the WHO classified 
it as a pandemic. I have to tell you, I think awareness is not enough. 
If the Congress does not act, our dependency on China for medications 
will continue to put American lives at risk.
  Yesterday, alongside my friend, the Senator from New Jersey, Mr. 
Menendez, I introduced the Securing America's Medicine Cabinet, or the 
SAM-C Act, to encourage an increase in American manufacturing of APIs. 
The act would expand upon the Emerging Technology Program within the 
FDA to prioritize issues related to national security and critical drug 
shortages and bring pharmaceutical manufacturing jobs back to the 
United States. In addition, the SAM-C Act authorizes $100 million to 
develop centers of excellence for advanced pharmaceutical manufacturing 
in order to develop these innovations. These centers will be 
partnerships between institutes of learning and the private sector.
  The number of API manufacturing facilities in China is still growing. 
It grows every single day. Although we cannot yet quantify our 
dependence on China's APIs, we do know the more Chinese products flow 
into the United States, the more potential there is for trouble.
  In 2007 and 2008, 246 people died as a result of adulterated Heparin, 
a widely used blood thinner. An investigation by the Centers for 
Disease Control determined that batches of Heparin manufactured in 
China had been contaminated. The contaminant, which is very cheap, was 
similar in chemical structure to Heparin and went undetected in routine 
tests.
  Since 2010, regulators have also found serious problems with batches 
of thyroid medication, muscle relaxers, and antibiotics. In 2018, the 
FDA recalled a number of blood pressure medications made in China that 
were contaminated with cancer-causing toxins.
  To be perfectly clear though, adulteration isn't the only concern. In 
2016, an explosion at a Chinese factory resulted in a global shortage 
of an important antibiotic because that factory was the drug's sole 
source of production. Think about that. The factory exploded, and there 
was a shortage of an important antibiotic because they were the only 
people who were making it. Without intervention, the FDA expects the 
pharmaceutical industry will continue to rely on Chinese companies to 
make these active pharmaceutical ingredients, the APIs.
  On February 27, 2020, the FDA announced the shortage of one drug that 
was used to treat patients with the coronavirus. They attributed the 
shortage to difficulties obtaining--guess what--the active 
pharmaceutical ingredients from a site in China that has been affected 
by the disease.
  The status quo has made us vulnerable, but the fix is sitting right 
in front of us. If we fail to act, we are placing our future in the 
hands of unregulated foreign countries we know to be bad actors. We 
have a lot of work to do before we will be able to call our supply 
chain and our healthcare delivery systems secure. But if we are 
learning anything, we are learning we need to bring this production 
back into the United States where there is proper oversight, where we 
know we are not going to have contamination in this supply chain for 
these active pharmaceutical ingredients. We must embrace telehealth, 
especially across State lines, and halt the breakdown of care in our 
rural areas.
  I have introduced bills that will help support those things, and I 
welcome additional cosponsors. The door is always open. All of this 
activity is here to secure our supply chain and our ability to access 
the healthcare that Americans need. Today I specifically ask that our 
colleagues support S. 3432, the SAM-C Act, Securing America's Medicine 
Cabinet Act. That is a first step in securing this pharmaceutical 
supply chain and securing the health and wellness of American 
consumers.
  I yield the floor.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. McCONNELL. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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