(Senate - October 29, 2019)

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[Pages S6245-S6247]
From the Congressional Record Online through the Government Publishing Office []


      By Ms. COLLINS (for herself and Ms. Smith):
  S. 2723. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
reduce drug storages, and for other purposes; to the Committee on 
Health, Education, Labor, and Pensions.
  Ms. COLLINS. Mr. President, I rise today to introduce legislation 
with my colleague from Minnesota, Senator Tina Smith, to help prevent 
drug shortages. Our legislation has the support of the American 
Hospital Association, the American Society of Anesthesiologists, the 
American Society of Clinical Oncology, the American Society of Health-
Systems Pharmacists, Premier, and the Institute for Safe Medication 
  I often hear from patients, pharmacists, and physicians who find 
themselves caught in the middle of a drug shortage, with very little 
certainty of when the problem might be resolved.
  For example, Wayne is a kidney and bladder cancer patient who called 
my Portland office about a shortage of BCG. Wayne received several 
treatments, went into remission, and then was declined additional 
preventive treatments that his doctor recommended due to this shortage. 
Wayne sees his physician every 90 days, but he lives with the constant 
fear that his bladder cancer could return, and the time and uncertainty 
between his appointments weigh heavily on him.
  I have also heard from patients living with a rare immunological 
disorder called Mast Cell Activation Syndrome who were affected by an 
IV Benadryl--diphenhydramine--shortage, as well as an Epi-pen shortage. 
One of these patients, a former nurse, spoke about the helplessness her 
family felt in trying to manage the shortage and was incredulous that 
shortages like these could be happening in a country like ours. She 
said, ``I am an in-charge kind of person, but I cannot fix this.''
  Physicians and hospitals try their best to manage these shortages 
behind the scenes but are understandably frustrated. Drug shortages add 
$230 million a year to U.S. drug costs and $216 million a year in 
increased labor costs. One of Maine's largest health systems reports 
that they address approximately two new impactful shortages a week and 
have had to commit 3.5 unbudgeted full time employees to address them.
  Another health system was experiencing 11 critical shortages and 30 
less critical, ongoing shortages. For one drug, the hospital pharmacist 
was able to procure a supply of the drug in shortage but had to switch 
to a more expensive product at ten times the cost.
  Our legislation, the Mitigating Emergency Drug Shortages Act of 2019, 
takes several steps to help FDA manage drug shortages. In the event of 
a likely drug shortage, our legislation gives FDA the authority to 

[[Page S6246]]

review of abbreviated new drug applications and manufacturing 
inspections. It also improves the timely and effective coordination 
between those conducting manufacturing inspections and the FDA Office 
of Drug Shortages.
  Our bill strengthens reporting requirements for pharmaceutical 
companies to disclose the root causes and expected duration of 
shortages. It also requires manufacturers to have contingency and 
redundancy plans to ensure the ongoing supply of essential medications. 
This is critical as we learn the lessons from Hurricane Maria in 2017 
in Puerto Rico. Approximately 10 percent of drugs prescribed in the 
United States are manufactured in Puerto Rico.
  Our bill also requires the Departments of Health and Human Services 
and the Department of Homeland Security to conduct a risk assessment of 
national security threats associated with the lack of adequate domestic 
capacity and capability for the manufacturing and distribution of 
certain critical drugs, their active pharmaceutical ingredients--APIs--
and associated medical devices used for preparation or administration. 
Today, China and India are the world's largest suppliers of active 
pharmaceutical ingredients.
  Finally, our legislation requires the Secretary to develop 
recommendations to incentivize manufacturers to enter the market for 
shortages as well as improve consumer notification of drug shortages.
  I thank Senator Smith for joining me in this effort to help combat 
this stubborn and persistent problem for patients and physicians. I 
encourage my colleagues to support its adoption.
  Thank you,
      By Mr. INHOFE:
  S. 2731. An original bill to authorize appropriations for fiscal year 
2020 for military activities of the Department of Defense, for military 
construction, and for defense activities of the Department of Energy, 
and for other purposes; from the Committee on Armed Services; placed on 
the calendar.
  Mr. INHOFE. Mr. President, for 58 years, the Congress has passed the 
National Defense Authorization Act with large bipartisan margins, and I 
believe we are going to do so again this year. In fact, we must. If it 
were up to me, it would have already been done by now.
  People have to realize that this is the most important bill of the 
year. It is one that we have to do. We have to do it by the end of the 
year--and that is the end of December--or we are not going to fund our 
military. I mean, that is how serious it is.
  I will keep working with my colleagues in the House and the Senate to 
get this done. I am going to say that again because there is an ugly 
rumor out there to the contrary. We are still working to get a 
comprehensive bill done. We are going to keep working on it.
  It is even more important because of what happened over the weekend. 
Our brave Special Operations forces successfully executed a dangerous 
mission to get ISIS leader al-Baghdadi, and it was successful. It was 
the right call by President Trump to bring down one of the most 
dangerous terrorists the world has ever seen, and it was successful.
  It also underscored the importance of the annual Defense 
authorization bill. There is no better time to pass an NDAA--that is 
the national defense authorization bill--that puts our servicemembers 
and their families first than after a perilous operation demonstrating 
the bravery, service, and sacrifice of our troops, because it took a 
lot of people to pull this off. But to ensure that we give the men and 
women in the Armed Forces the tools they need to fight and win no 
matter what, we are filing a ``skinny bill'' today. Let me explain what 
that is.
  We have to have a defense authorization. It has to happen. It is one 
that has happened for 58 years in a row. It has to happen. It has 
happened for 58 years in a row. If it has happened for 58 years in a 
row, it is going to continue to happen. We all know that.

  The problem with that is, everybody knows it is going to pass. 
Consequently, people put more and more things on the bill, and many of 
the things have nothing to do with the military because they know the 
bill is going to pass. What happens is, then they decide to get 
everything in there, and consequently there are so many people lined up 
with different things they want to put on the Defense authorization 
bill that we have not been able to come to an agreement.
  This has happened in the past. What happens is, in the event of the 
Defense authorization bill--this would be the largest bill of the year, 
the most significant bill of the year--if, for some reason, we are not 
able to pass it, military operations will stop.
  A skinny bill is simple. It extends necessary authorities for 
military operations, takes care of servicemembers and their families, 
and authorizes essential military construction and acquisition 
programs. That is it. That is one paragraph. That is all it does. That 
part has to pass. At the end of the day, that is what we have to do by 
the end of this year, by the end of December.
  There is this old document that nobody reads anymore; it is called 
the Constitution. If you read that, it says what we are really supposed 
to be doing, what is really important.
  I say to my friend from West Virginia, out of all the things we do, 
sometimes they are not all that significant. This is that significant. 
That is why this is important. It is going to pass. We ought to make 
sure it passes.
  By introducing this as a skinny bill, it takes out everything that 
has nothing to do with the military, and we just pass the bill to take 
care of our troops.
  Here on Capitol Hill, the NDAA--National Defense Authorization Act--
is an institution itself, the last bill of its kind, an authorization 
bill that passes every year.
  We always have disagreements within and between parties on the future 
of national security, but we have always managed to overcome those 
divisions to support our military. This year is not going to be any 
  Earlier this year, I worked with my Democratic colleague Senator Jack 
Reed to produce a bipartisan NDAA in the Senate. We did a great job. We 
spent hours on it, but we ultimately passed it out of committee almost 
unanimously--Democrats and Republicans alike. We brought it to the 
floor, and we passed it.
  It is not the bill where Jack Reed and Jim Inhofe would necessarily 
agree on every aspect, but these are tough decisions, and we had to 
make decisions, so we made decisions. Consequently, when it came up to 
the floor, it passed by 86 to 6. Only six people opposed it in this 
entire body.
  The same has to be true with any kind of agreement on fiscal year 
2020 NDAA. That bill would require 60 votes in the Senate. It will 
require Republican votes in the House. The bill that came out of the 
House, from the House committee on the Defense authorization bill, 
didn't have one Republican voting for it. Obviously, it has to have 
Republicans in the House vote for it. It has to pass by a 60-percent 
margin. There is no other way it can be done.
  We continue making progress. We know we can't pass a bill with as 
many partisan provisions as we saw in the House bill--things like 
unprecedented restrictions on the President's ability to defend 
America, defend the Nation, and putting social agenda above the needs 
of our troops. Unfortunately, the same problem that is slowing progress 
on the NDAA is also stalling the appropriations process.
  When I supported the Bipartisan Budget Act of 2019, I argued that a 
lower topline was acceptable if it got us on-time passage of the NDAA 
and the defense funding, but now we are facing a delayed NDAA and the 
real possibility of a full-year continuing resolution. This is 
  The Department of Defense has never operated under a full-year CR. A 
CR is a continuing resolution. A CR would simply be disastrous. What it 
says is, we are going to do the same thing for the military and the 
rest of the government as we did last year. Well, the needs have 
changed. We have new programs that have to be authorized and have to be 
voted on. It would be a huge waste of taxpayers' money if we were 
unable to get this thing done.
  We know a full-year CR would press pause on hundreds of new weapons 
programs and leave tens of billions of dollars in the wrong places.
  We had a meeting where we had General Martin testify. He is the Vice 
Chief of Staff of the Army. For the Army alone, he said we would be 
looking at delays to new-start programs and increased costs of 37 
programs, totaling $7 billion. That is according to

[[Page S6247]]

the Vice Chief of Staff of the Army. That is the Army alone. The total 
failure is going to be somewhere around $22 billion that would be lost.
  All said, this would put work rebuilding our military even further 
behind and waste enormous amounts of taxpayer dollars.
  The national defense strategy--that is this book. This is kind of 
interesting because this book was put together by Democrats and 
Republicans, all with expertise and a background in the military, equal 
number of Democrats and Republicans, and they all agreed that this was 
going to be our defense strategy. They have a National Defense Strategy 
Committee. That national defense strategy provided a clear vision of 
the serious challenges it faces and the necessity of ``urgent change at 
significant scale.'' That is what Secretary Mattis stated.
  Failure to pass an NDAA and accepting a full-year CR would stop our 
Nation's defense strategy in its tracks. It would undo all the good 
work we have done with Secretary Esper, the President of the United 
States, the Pentagon, as well as our partners, to follow the 
recommendations of the NDS Commission report.
  This is not just inside-the-beltway gridlock. The world is watching. 
Our allies and our enemies are watching. They want to know if America 
is serious about its role in the world and its own national defense.
  Failure to pass basic legislation on a timely basis to support our 
military sends a terrible signal that undermines our national security. 
Think of the signal that sends to our troops who are out there risking 
their lives to defend us here at home.
  Caring for our troops is about the only thing anyone in this town 
agrees on. If we lose that bipartisan support, it will be hard to get 
it back, and we need it now more than ever.
  China and Russia. This is interesting because we didn't used to be 
that concerned about them. I would say that during the Obama 
administration, his priorities were not the same. He was very honest 
about it. He had other priorities. So we didn't do the job we should 
have done at that time for our military. China and Russia are not 
waiting around for us to end our disagreements with each other.
  During the last administration, under Obama, our military funding 
decreased by 25 percent. Between the years of 2010 and 2015, we 
decreased the amount of funding for our military in that administration 
by 25 percent. Meanwhile, China had increased spending by 83 percent 
over the last decade. Think about it. China increased its spending by 
83 percent, and we reduced ours by 25 percent.
  They are continuing a campaign of aggression, building islands in the 
South China Sea. Our allies over in the South China Sea are watching 
what China is doing there and around the world and what we are not 
doing. They have come to the conclusion that a third world war may be 
imminent, and they are not sure whose side they want to be on.
  This chart I am showing right here is a picture of hypersonic 
weapons. These are state-of-the-art weapons. These are missiles that 
travel at five times the speed of sound. This is something we were 
ahead on during the beginning of the previous administration, and we 
are now behind. Right now, China is parading dozens of massive 
hypersonic missiles, and we have haven't even built one yet.
  There they are. That is a picture I haven't seen until today. Those 
are hypersonic weapons, and they were on Tiananmen Square on October 1, 
2019. A lot of people didn't know that they are--they have not just 
caught up with us; they have passed us. We haven't built one yet, and 
there they are.
  People don't realize where China and Russia are. That is China, but 
Russia continues to develop new and dangerous nuclear weapons, while it 
expands its influence in the Middle East and elsewhere.
  I have no doubt that a united America can face these challenges. I 
fear that a divided America--a country that allows defending America to 
be a partisan issue--cannot.
  The path to a final defense bill is, as it always has been, 
bipartisan. The Defense authorization bill has historically enjoyed 
broad bipartisan support, and that is not an accident. Both parties 
have compromised to get a bill worthy of our troops and worthy of our 
troops' sacrifices.
  I hope we get to a place where we can find common ground to give our 
troops and military a comprehensive bill. That is what we want to 
continue to do.
  We have been working on this bill for a long period of time. 
Normally, it doesn't take this long. We have gotten it down to what 
they call the four leaders. I am one of those four leaders who have 
been trying to put this together, but we have not been able to get it 
  What we are doing with this bill is we are putting the bill up. We 
are going to get it on the floor so we can be ready.
  Here is the problem: If we don't do it, we can sit around and do 
nothing through the month of November, and when December gets here, all 
of a sudden, we are going to be faced with the fact that we are going 
to have some bill that takes care of just the military, not all the 
other stuff that is on the bill. To do this, you have to pass it out of 
committee. You have to take it to the floor of the Senate. You have to 
pass it out. Then, if you get that far, the House has to do the same 
thing. Then we go into conference, and we confer on this thing.
  Obviously, that is going to take not just days but weeks. So to 
prepare for the unlikely possibility that we don't get together, we do 
have the skeleton bill that we are going to introduce. I am going to 
introduce it an hour from now. It is the only thing we can do right now 
to make sure we can take care of our troops if we are not able to get 
the comprehensive bill completed. That is the reason for it. I will be 
introducing it.
  Every provision in that bill is a provision to enhance our military 
efforts, to pay our troops, and to take care of our country the way we 
have been able to do in the past.