[Congressional Record Volume 159, Number 161 (Wednesday, November 13, 2013)]
[Senate]
[Pages S7970-S7971]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                     DRUG QUALITY AND SECURITY ACT

  Mr. BURR. We have heard about horror stories. I want to talk about 
another one, the bill that is in front of the Senate today, the Drug 
Quality and Security Act.
  The Senate has an important opportunity to advance balanced 
bipartisan legislation on behalf of our Nation's patients. The Drug 
Quality and Security Act will respond to the tragic events surrounding 
last year's meningitis outbreak and will strengthen and improve our 
national pharmaceutical supply chain. Last year's unfortunate 
compounding meningitis outbreak has reminded us that had the early 
warning signs been heeded, we might have been able to prevent or 
mitigate the crisis in the first place.
  In light of what Congress has learned since the outbreak first 
occurred last fall, this bipartisan legislation includes provisions 
that respond to and take a big step toward addressing the issues which 
led to the unfortunate pharmaceutical compounding tragedy over 1 year 
ago.
  America's patients expect and deserve the peace of mind that 
medicines they take are safe and effective. FDA's repeated warnings of 
counterfeited drugs making their way into our prescription drug supply 
chain and the increased number of pharmaceutical thefts are the early 
warning signs of a potential and growing threat that could 
significantly compromise or endanger the health and well-being of 
patients across our Nation.
  In recent years, States have responded by putting new requirements in 
place. At a time when we should be working to lower the cost of health 
care, this increasing patchwork of State and regulatory requirements 
is, instead, driving up the cost of health care in America.
  For more than 1 year I have worked with Senator Michael Bennet and my 
colleagues on the Senate Health, Education, Labor and Pensions 
Committee on bipartisan legislation to address these problems and to 
strengthen the safety, security, and accountability of our Nation's 
pharmaceutical drug supply chain.
  The Drug Quality and Security Act, which we have before us today, 
includes provisions that will establish strong, uniform prescription 
drug-tracing standards that reflect today's realities and ensure a 
safer and more secure pharmaceutical drug supply chain.
  The Drug Quality and Security Act establishes a uniform electronic 
unit-level system over the next decade that will increase the security 
and ensure a safer pharmaceutical drug supply chain from manufacturers 
all the way to dispensers. This legislation will require trading 
partners to be authorized to pass and receive information as part of 
their transactions. It raises the wholesale distribution licensing 
standard. It establishes licensure standards for third-party logistics 
providers and requires suspect and illegitimate products to be 
appropriately handled.
  I would like to thank Chairman Harkin and Ranking Member Alexander 
for their leadership on this very important bipartisan bill. I 
especially would like to recognize Senator Bennet, who has been a 
strong partner throughout the crafting of this legislation. For more 
than 1 year we have worked together on this bipartisan legislation with 
our colleagues and have finally achieved an important balance with this 
bill.
  I might add we were told this couldn't be done. We were told this was 
too difficult. But for 1\1/2\ years we have tackled this objective. 
Congress has the opportunity to proactively put in place uniform, 
workable standards that will allow stakeholders greater regulatory 
certainty and give patients the confidence they deserve in the safety 
and security of our Nation's pharmaceutical drug supply chain.
  Congress's opportunities are twofold because this legislation is also 
our chance to respond to a crisis that impacted the lives of hundreds 
of patients nationwide, and I hope my colleagues will join me in 
supporting the Drug Quality and Security Act.


                              Health Care

  To follow up the conversations on today's bill, I listened to my good 
friend Senator Blunt talk about Aaron, one of those Americans caught in 
the crosshairs of the Affordable Care Act and its unintended 
consequences. I was home this weekend and I was stopped by five 
individuals--five individuals--with practically the identical story. 
They came up and said: Richard, I was covered. I had insurance. I have 
no preexisting conditions, nor does anybody in my family. I had a 
$10,000 deductible insurance policy that cost me about $450 a month, 
and I had the security of knowing it was there. I just got my new 
notice and my insurance went to a $15,000 deductible and my monthly 
premium is $1,440. These are five individuals--five different 
families--but with a similar story.
  I think of the yearlong debate we had on the Affordable Care Act and 
the claims that were made: reduced premiums, bring down health care 
costs, provide coverage for those who don't have it. Today what do we 
see? Today's snapshot, and this may change: dysfunctional Web site, 5 
million people who have been notified they have lost their insurance, a 
very tepid enrollment of individuals, and what has gotten lost in 
reality is that there are hundreds of thousands of Americans

[[Page S7971]]

just like the five who came up to me this weekend. They are still 
getting insurance, but their deductible went up to $15,000 and their 
premium went up to $1,440 a month.
  Tell me, where in that scenario is this affordable? Tell me, where in 
this process did they get a better plan than they had before? Their 
deductible went up $5,000. That means the first $15,000 of their health 
care is coming right out of their pocket and they are paying $1,440 a 
month to have the security of knowing there is insurance after that.
  Clearly, these are five Americans who would tell me this falls 
woefully short of the promises made to them. I would be willing to bet 
in every State, in every House district around the country, we are 
going to continue to hear stories about this.
  We will, I am sure, debate heavily where we move to from here. But 
don't forget that under this bill, now that we have extended the 
enrollment period to March 31, under the law every insurer who bids to 
be in the exchange, starting April 1 of next year through April 27, has 
to submit their bids for 2015. Let me repeat that. For every insurer 
that wants to be in the exchange, starting April 1 of next year through 
April 27, they will have to submit their premium bids for 2015. They 
are going to do that having no experience with the pool of insured 
lives because we have extended until March 31 the enrollment. That 
assumes the Web site gets fixed and that people are going to enroll. 
With little actuarial history, these insurance companies are going to 
have to bid for 2015. Imagine what the premium cost is going to be in 
2015 when it is not 5 percent of the American people now in the 
exchange but it is 100 percent--it is all the employers that are 
impacted by 2015 prices.
  I have always been taught there are signs you should pay attention 
to. When five people come to you and say: Listen, my deductible went 
from $10,000 to $15,000 and my premium went from $450 to $1,440, that 
is a warning sign. We ought to listen to it.
  We still have a chance to fix this. Most important, as Senator Blunt 
talked about, it means when you have a high-risk pool in Missouri and 
North Carolina, you let them keep the high-risk pool. We can manage it 
much better on a State level than we can in nationalizing and doing 
top-down health care in this country.
  This will not be the end of the conversation on the Affordable Care 
Act. The American people deserve better and this Congress must produce 
it.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Indiana.
  Mr. COATS. Madam President, there is an old expression used by many 
Hoosiers and others across America that is time tested: Your word is 
your bond. In Indiana, as in so many other places across our country, 
we value honesty and good old-fashioned truth-telling, even if it hurts 
a little bit to hear the truth.
  Having spent the previous 4 days in Indiana listening to Hoosiers, it 
is clear to me many people in my State--and as I am reading, 
nationwide--are pretty fed up with Washington right now, and they have 
good reason to be. They are frustrated because the promises that were 
made to them are being broken and outright guarantees have been 
disregarded.
  President Obama, both before and after his signature legislation--now 
called ObamaCare--passed, promised all Americans they could keep their 
health insurance plans if they liked those plans. It was a promise 
repeated over and over again. For many Americans it was the sole reason 
they supported the Affordable Care Act. But the President's guarantee, 
announced publicly by him several times, simply was not true.
  In recent months, millions of Americans have received notifications 
their plans are being canceled because of the ObamaCare law, and 
reports indicate now the White House has known this for over 3 years--
that these cancellations were coming. So when the American people found 
out the White House knew the bad news was coming all along, they were, 
to put it mildly, not happy.
  It is clear that some of those who voted for ObamaCare and continued 
to support it are now agreeing with the majority of Americans that the 
President's health care law simply is not working. One such Member has 
floated the idea of having the Government Accountability Office and the 
inspector general for the Department of Health and Human Services 
conduct ``a complete, thorough investigation to determine the causes of 
the design and implementation failures of HealthCare
.gov.''
  We need to talk about the fundamental policies and provisions that 
undermine this law going forward.
  Fixing the Web site, if that happens--it can happen and eventually it 
would have to happen--is not the real problem. The real problem is a 
flawed design. Two Democrats have introduced a bill entitled ``Keeping 
the Affordable Care Act Promise Act.''
  A House Democrat recently stated, ``I think the President was grossly 
misleading to the American public'' when he promised Americans they 
could keep their health care coverage if they liked it. Even former 
President Bill Clinton has said he thinks the President's pledge to 
allow Americans to keep their coverage should be honored.
  In an interview this week, former President Clinton said:

       So I personally believe, even if it takes a change in the 
     law, the President should honor the commitment that the 
     Federal Government made to those people and let them keep 
     what they got.

  There is a growing admission from the supporters of ObamaCare that we 
are dealing with more than just a Web site glitch; that we are dealing 
with fundamental policy design flaws. So I agree with President 
Clinton. Regardless of whether you support ObamaCare, there should be 
100 percent bipartisan support for letting Americans keep what they 
have been promised--that they can keep their existing health care 
insurance plans if they like them.
  It is time to acknowledge, however, as Senate minority leader Mitch 
McConnell said yesterday, that it goes beyond this; that the Affordable 
Care Act is beyond repair. This disastrous law needs to be repealed and 
replaced with real reforms that drive down the cost of health care, 
increase the quality of care, and put patients, not Washington 
bureaucrats, in charge of their health care decisions.
  Unfortunately, this President and Senate Democrats have made it clear 
they will never allow a full repeal to pass, despite all the broken 
promises to the American people and despite the fact the law simply 
isn't working.
  Given this reality, the appropriate step, I believe, and one with 
growing, bipartisan support is for a 1-year delay of the implementation 
of ObamaCare.
  I have offered a bill to delay the individual mandate--to join with 
the decision already made by the President to have a 1-year delay of 
the employer mandate--so all Americans can have the same relief, not 
just business. By delaying the mandates--all the mandates in this 
health care law--we can give the American people a fundamental choice 
when they go to the polls in 2014: continue ObamaCare or replace it 
with sensible, affordable reforms that drive down the cost of care, 
increase the quality, and, most important, put patients, not Washington 
bureaucrats, in control of their health care decisions and their health 
future.
  In closing, I would say this to the President: Your word needs to be 
your bond. As Albert Einstein once said: Whoever is careless with the 
truth in small matters cannot be trusted with important matters.
  I yield the floor, and I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Ms. WARREN. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Ms. WARREN. Madam President, I ask unanimous consent to speak as if 
in morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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