[Congressional Record Volume 166, Number 53 (Thursday, March 19, 2020)]
[Senate]
[Pages S1827-S1828]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  SECURING AMERICA'S MEDICINE CABINET

  Mrs. BLACKBURN. Mr. President, we are continuing to roll out our 
response to the coronavirus and to this pandemic, and I want to 
encourage my colleagues to begin to think about how we move past this 
immediate crisis that we are in and begin to look toward what is going 
to happen in the future with our supply chains and our healthcare 
delivery systems.
  As we talk about the problems that are before us today, let us not 
forget that 3 months from now, 6 months from now, a year from now, we 
need to be looking at today and say: Here were the lessons learned, and 
these are the steps that we have taken to make certain that it doesn't 
happen again.
  What we have learned and what many Americans know is something that 
some of us started working on a couple of years back. It was looking at 
the fact that Americans and American drug manufacturers rely heavily on 
Chinese companies to produce active pharmaceutical ingredients, or 
APIs, as they are called. We also know that bad actors in China are 
poised to use that vulnerability as leverage and to use it as a way to 
disrupt and interrupt the supply chain of those active pharmaceutical 
ingredients coming into our country.
  This is an issue that we cannot wait to address. This is something we 
need to do right now. That is why my colleague from New Jersey, Senator 
Menendez, and I introduced the Securing America's Medicine Cabinet Act, 
or the SAM-C Act, as a way to encourage and increase American 
manufacturing of these active pharmaceutical ingredients.
  Here is what it would do. It would expand upon the Emerging 
Technology Program, which is housed within the FDA, to prioritize 
issues related to national security and critical drug shortages and 
bring that pharmaceutical manufacturing out of China and back into the 
United States, not in 5 years or 10 years but now. It is something that 
we need to do right now.
  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. Certainly, we have 
talked a lot about public-private partnerships and the necessity of 
them to move us through this crisis, and we have cheered as the 
President has brought private sector companies into the White House to 
work with him on addressing these issues.
  One thing we have to realize--and why this is important that we do it 
now--is that the number of API manufacturing facilities in China is 
still growing. China has found a vulnerability in our system, and it is 
continuing to exploit that vulnerability. Although we don't yet know 
down to the precise percentage how dependent we are on these Chinese 
APIs, we do know that the more Chinese products that flow into the 
United States, the more potential there is for trouble and the more 
vulnerable our supply chain is.
  The bottom line is that, if we continue to rely on the Chinese to 
stay healthy, we will be doing so at our own peril. So I am asking my 
colleagues to join Senator Menendez and me and support this legislation 
as a part of these coronavirus response efforts that we are making.
  The spread of the Chinese coronavirus has put considerable strains on 
our healthcare delivery system. Primary care physicians are overbooked, 
and potential patients are afraid of going to clinics at all for fear 
of putting an elderly or a vulnerable person at risk. I am in daily 
contact with physicians' offices and nurses' practices. I am hearing 
from those who care for the elderly and from caregivers for those who 
have complex medical conditions, and this is a primary concern. For 
that reason, conversations here on Capitol Hill have turned toward 
boosting telehealth services in order to free up in-person appointments 
for those who need them the most.
  I am so grateful that the Vice President and the coronavirus task 
force have made this a priority. We appreciate that. The coverage of 
these efforts has made telemedicine feel, to many, like a new concept, 
but thank goodness we started building the foundation to support 
healthcare technology years before COVID-19 spread beyond China's 
borders.
  As just a little bit of history, back in 2015, when I was over in the 
House, I introduced the SOFTWARE Act, which was to eliminate redtape 
that was preventing innovation in healthcare delivery. The bill ended 
up being rolled into a piece of legislation called the 21st Century 
Cures Act, which we passed through the House in late 2015. In 2016, it 
cleared the Senate.
  The SOFTWARE Act directs the FDA to come up with a more efficient way 
of approving healthcare software so it will not discourage innovation 
because, at that point, that is what we were beginning to see. The 
redtape would just pile up on the new concepts in delivery, and by the 
time one would get approved, a new generation of technology would begin 
to emerge.
  SOFTWARE's provisions made it possible for regulators and the private 
sector to bring us a lot of new innovations. We have Teladoc, Noom, 
Fitbit, and hundreds of other healthcare applications that we carry on 
our mobile devices. We have also seen many hospitals conduct post-
operation care to patients once they go home. They are entering their 
data on iPads that are specific to their surgeries, and those 
physicians are monitoring their care and recoveries. This push for 
responsible tech policy has gone hand in hand with efforts to bring 
broadband to rural and unserved areas.

[[Page S1828]]

  Last year, I introduced the Internet Exchange Act, which enables 
these communities to support the high-speed internet connections that 
the telehealth software requires. Now, we all know that you cannot have 
access to 21st century healthcare or emergency response without having 
access to high-speed internet. These concepts go hand in hand. At a 
time when we are facing a global pandemic and the impact that this has 
on our country and our citizens, we know everyone needs that access and 
should be able to go in and access this care.
  Last year, as part of a rural health agenda that my team and I 
developed in working with our State and local electeds, I introduced 
the Telehealth Across State Lines Act so that we could bring healthcare 
to the patient rather than always taking the patient to the healthcare. 
I am so appreciative that Administrator Verma, of CMS, is paying close 
attention to this and is working carefully to relax some of the rules
  Telehealth Across State Lines would lead to the creation of uniform 
national best practices for the provision of telemedicine across State 
lines. Second, it would set up a grant program to expand existing 
telehealth programs and incentivize the adoption of telehealth by 
Medicare and Medicaid--two things that are needed.
  We have seen these gaps in access to care. This is one way we can 
make certain that everyone, during these times of a pandemic, has 
access to care. Anyone who has ever videoconferenced into a meeting--
and I will tell you that my staff has been doing that with employers 
and with organizations and with citizens around our State--knows this 
is a game-changer during a time when people are not able to go in for 
meetings.
  My support for telemedicine has been grounded in more than just 
convenience. The forethought behind this push for telemedicine was to 
ask: How do we make it more accessible? How do we make certain the care 
you are able to receive does not depend on the ZIP Code in which you 
live? Right now, as we are talking about testing and communicating with 
doctors and being curious as to if we have symptoms and how to treat 
symptoms, accessibility is so important.
  What we have learned from the dangers posed by fears of the Wuhan, 
China, coronavirus and the spreading of this virus is that it has made 
us realize that, actually, telemedicine and access to telemedicine 
makes accessing healthcare safer in so many instances--for the elderly, 
for those who are homebound, for those with complex medical situations.
  My colleagues will recall, during the first meeting that our 
conference had with the administration regarding the coronavirus 
response, I specifically asked officials with the Centers for Medicare 
and Medicaid Services to push for the temporary relief of section No. 
1135 regulations, which would prevent patients from taking advantage of 
telehealth services. Aren't we grateful that this has been lifted? I 
thank President Trump for green-lighting that. It is what you call a 
win for consumers who have a difficult time in getting to physicians' 
offices.
  It is time for Medicaid and private health insurers to get on board 
and cover these telehealth services. For our private insurers, it will 
make it easier for those who are covered under their insurance plans to 
get to the care they need in a timely manner. For our State Medicaid 
officials, this will involve rethinking some of their licensures and 
other procedures. For insurance companies, it will involve making 
complex but responsible business decisions.
  Let's remember we are all in this fight together against the 
coronavirus. We are in this fight together. It is up to us to find 
solutions as to how Americans are going to be able to access the care 
they need when they need it. We need to address these things 
immediately because this is no longer our just talking about 
convenience or our being able to call in to a meeting. The coronavirus 
has evolved into a global threat. Technology that can spare people from 
the risk of exposure should not be seen as a luxury or only available 
to a few. We have the tools we need to suppress the transmission of 
COVID-19 in the United States, and we have a plan to secure our 
pharmaceutical and our healthcare supply chains.
  It is time to get it done. We are the United States of America. We 
can come together and respond to this attack by this virus. We can 
defeat it, and we can make certain there is a way to provide access to 
healthcare for all Americans regardless of the ZIP Codes in which they 
live.
  I yield the floor.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER (Mr. Braun). The clerk will call the roll.
  The senior assistant 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 (Mr. Cramer). Without objection, it is so 
ordered.

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