[Congressional Record Volume 164, Number 188 (Thursday, November 29, 2018)]
[Senate]
[Pages S7220-S7221]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                          Lowering Drug Prices

  Mr. GRASSLEY. Mr. President, millions of Americans woke up this 
morning and started the day with their doses of prescription 
medications. Their daily regimens are prescribed by their healthcare 
providers to treat illnesses and to improve the quality of their lives, 
and for many Americans, prescription medicine extends and saves their 
lives. Without their prescription medication, millions of Americans 
would not survive.

  For so many of our loved ones who have diabetes, high blood pressure, 
cystic fibrosis, epilepsy, or other chronic healthcare conditions, 
prescription drugs are a basic necessity for their living. Without 
pharmaceutical treatment or cures, too many family gatherings at 
Thanksgiving, which has just passed, arguably, would have had fewer 
plates at the table this holiday season.
  As a nation, we are incredibly blessed to live in a country where 
investment and innovation unlocks cures and treatments. Yet the 
escalating price of prescription drugs are a consuming concern for too 
many millions of Americans, even including Iowans who bring up this 
subject regularly at my county meetings.
  I have come to the floor of the Senate to address the sticker shock 
that greets consumers when they pick up their medicine at the pharmacy 
or open their medical bills after a hospital visit. Rising drug prices 
that Americans pay out of pocket are gobbling up a bigger share of 
income.
  For some people on a fixed income, sky-high drug prices are eating up 
every spare penny they can scrape together to pay for their 
prescriptions. It is time we talk turkey to our friends at Big Pharma. 
I don't make fun of our friends at Big Pharma. I use the word 
``friends'' because we all enjoy a longer life and better quality of 
life because of miracle drugs.
  As a fiscal conservative who wholeheartedly believes in free 
enterprise, I don't want the government intruding unnecessarily in the 
marketplace. The reason millions of Americans benefit from lifesaving 
drugs in the first place is due largely to capitalism and the 
entrepreneurial spirit that drives innovation and opens new frontiers 
of modern medicine.
  I also believe strong intellectual property rights help incentivize 
companies to invest in research and development so new cures are found 
for our loved ones. However, government does have a responsibility to 
keep a check on unfair business practices and to actually rein in anti-
competitive behavior that harms consumers and fleeces taxpayers.
  There is a general agreement that these are constitutional as well as 
legitimate roles for government. Of course, if you are going to protect 
the consumers and not fleece taxpayers, this can happen in a number of 
ways.
  It happens when brand-name and generic drugmakers game the system to 
pad their profits at the expense of taxpayers and consumers. It happens 
when hospitals, middlemen, and providers determine which drugs to 
prescribe based on its reimbursement and markup from insurers, 
including public health programs for the military and veterans or the 
big ones like Medicare and Medicaid.
  Throughout my public service in the U.S. Senate, I have established a 
fundamental commitment to transparency. Remember that transparency, 
particularly in government, brings accountability, but transparency in 
the private sector will also bring accountability.
  From whistleblower protections to the public's right to know, 
sunlight sweeps away wrongdoing, strengthens good government, and helps 
consumers and taxpayers get the most bang for the buck. I have worked 
across the aisle to apply this standard to help lower drug prices. It 
is an issue that resonates loudly and very clearly in every household 
of America.
  In fact, Iowans contacted my office a couple of years ago regarding 
real sticker shock for their EpiPens. The escalating price they were 
paying for lifesaving anti-allergy medication jumped $600 for a two-
pack. On their behalf, I started digging for answers.
  It turned out that Mylan, the EpiPen distributor, had jacked up the 
price for over a decade during the Obama administration. In fact, from 
2006 through 2016, it rose more than 400 percent.
  EpiPen is the most widely prescribed epinephrine autoinjector in the 
United States. Parents, grandparents, daycare providers, and teachers 
across the country keep their homes, their cars, and their classrooms 
stocked in case of an emergency.
  A 400-percent increase--how was Mylan able to accomplish this? It 
classified EpiPen as a generic drug instead of a brand-name drug in the 
Medicaid Drug Rebate Program. Simply, that incorrect classification 
cost the U.S Treasury and States big time by allowing Mylan to pay 
lower rebates.
  The watchdog at the Department of Health and Human Services, at my 
request, found the misclassification may have resulted in the taxpayers 
and the States overpaying for the drug by as much as $1.3 billion.
  What is more, a competing pharmaceutical company sued Mylan using the 
False Claims Act--a whistleblower law I have updated over the years. 
This anti-fraud tool encourages people to report and expose wrongdoing 
against the government. In this specific case, this whistleblower 
exposed fraud against the taxpayers for misusing the Medicaid Drug 
Rebate Program to the tune of $456 million.
  I would like to share a time-tested lesson I have learned throughout 
my 30 years of oversight work in the U.S. Senate: When you smell smoke, 
there is a fire.
  The EpiPen misclassification may be the tip of the iceberg. As part 
of my EpiPen oversight, I requested additional misclassification data 
from the Office of Inspector General at HHS.
  As of early 2018, the Office of Inspector General identified the 
names of 10 drugs that accounted for 68 percent of Medicaid 
reimbursements for potentially misclassified drugs just in the year 
2016. The EpiPen and some of its variants are included within the group 
of 10 drugs, as well as a commonly prescribed antibiotic and a commonly 
prescribed drug for an underactive thyroid condition.
  In a nutshell, it appears the same drug companies may be undermining 
the rebate program by misclassifying commonly prescribed drugs that can 
be found in medicine cabinets in households all across the United 
States. That is simply wrong, and I am going to do whatever I can to 
fix that issue.
  Recently, the FDA approved the first EpiPen generic. Of course, that 
is a good step in the right direction.
  As a senior member of the Senate Finance Committee and also the last 
4 years as chairman of the Senate Judiciary Committee, my sights are 
set squarely on lowering drug prices without compromising access for 
innovative cures and treatments delivered by the American 
pharmaceutical industry.
  Through oversight and even legislation, I am working to set things 
right. That includes putting a stop to the shenanigans that manipulate 
regulatory loopholes and unfairly extend monopolies over certain drugs. 
This happens when a brand name and a generic drugmaker work in cahoots 
to delay the lower priced generic's entry into the market.
  For starters, a bipartisan bill I have with Senator Amy Klobuchar of 
Minnesota would inject a healthy dose of Midwestern commonsense 
medicine into Big Pharma with a bill we have that would do away with 
what we call the pay-for-delay shenanigans. This bill, called Preserve 
Access to Affordable Generics Act, would end sweetheart deals between 
brand-name and generic drugmakers that end up costing the American 
consumer and at the same time the U.S. taxpayers an arm and a leg. It 
would increase access to more affordable generic drugs sooner rather 
than later because of the pay-for-delay scheme.
  Specifically, our bill would crack down on anti-competitive payoff 
schemes that effectively rip off taxpayers and consumers. These so-
called

[[Page S7221]]

reverse agreements delay consumer access to the cheaper generic drug.
  I am 100 percent certain that our pay-for-delay bill would help lower 
drug prices for our consumers and save the taxpayers money through 
Medicare and Medicaid. That is because generic drugs can be up to 90 
percent cheaper than brand-name drugs, and that happens to be a 
tremendous savings.
  Ending these payoff agreements would gut artificially inflated prices 
consumers are paying for some prescription drugs. Putting an end to 
these payoff schemes will end the choke hold they put on the market. By 
doing so, we can restore timely access for affordable generics to reach 
the market, boost competition, expand consumer choice, and at the same 
time lower drug prices.
  In addition to the pay-for-delay bill that Senator Klobuchar and I 
have, I am also cosponsor of a bill led by my friend Senator Pat Leahy 
that would inject another dose of bipartisan common sense into the 
pharmaceutical industry. We use the acronym CREATES for this 
legislation, the Creating and Restoring Equal Access to Equivalent 
Samples Act. It seeks to stop anti-competitive practices that block 
lower cost generic drugs from the pharmacy store's shelves. It would 
help generic companies get the samples they need to manufacture 
equivalent products.
  Right now, a common practice by bad actors in the industry prevents 
potential generic competitors from obtaining the samples they need to 
test their drugs or blocks them from participating in shared safety 
protocols. This practice of deny and delay is fueling deficit spending. 
That is because the tax-paying public shells out a whole lot more money 
to fill brand name prescriptions for veterans, the elderly, and the 
disabled, when the cheaper generic drugs would do the same thing. This 
would save a tremendous amount of money. We have the scoring by the 
Congressional Budget Office saying that our bill--the CREATES bill--
would result in a $3.8 billion net decrease in the Federal deficit.

  Improving access to lower cost generic drugs while preserving the 
incentives for innovation and intellectual property rights ought to be 
seen by my colleagues as a win-win solution.
  I hope you will not just take my word for it. More than 80 
organizations supported the final passage of the CREATES Act. They 
would go all the way from the AARP over to the Consumers Union, which 
tend to be liberal organizations, all the way over to Taxpayers for 
Common Sense, which I think generally tends to be more conservative.
  Our CREATES bill was approved in June by the Senate Judiciary 
Committee, which I chair, and has 30 Senate cosponsors. In addition to 
this legislation, I am also keeping tabs on proposed buyouts and 
mergers in the pharmaceutical supply chain. Without a doubt, increased 
market integration will impact consumers and taxpayers.
  For example, the mergers of Cigna Corporation with Express Scripts 
Holding Company and the CVS Health Corporation with Aetna may 
negatively impact consumer choice. According to the Kaiser Family 
Foundation, once completed, these two mergers would result in just four 
entities controlling 71 percent of all of Medicare Part D enrollees and 
86 percent of stand-alone drug plan enrollees.
  Notwithstanding the consumer benefits of business integration that 
can include more innovation and cost-saving efficiencies, we can't 
afford to turn a blind eye to potential negative consequences that 
consolidation in the U.S. pharmaceutical supply chain may have in the 
marketplace.
  I will wrap up my remarks today with this message for the American 
people: President Trump made a promise to the people to lower drug 
prices. His administration is working to deliver on that promise. Most 
of the stuff that has gone on so far has been within what the law 
allows the President, through the Secretary of HHS, to do so that 
Congress doesn't have to be involved in everything. But Congress can 
surely give support to this program.
  The President's blueprint for bringing down prescription drug prices 
lays out four principles: Boost competition, enhance negotiation, 
create incentives for lowering list prices, and, lastly, bring down 
out-of-pocket costs.
  Last month, he signed the Patient Right to Know Act into law, so he 
has the help of some new legislation now. I cosponsored this bill by 
Senator Susan Collins to ban what are called ``gag clauses,'' which 
keep pricing information from consumers every time they visit the 
pharmacy counter.
  The new law prevents health insurance companies from prohibiting 
pharmacy providers from sharing pricing information with consumers. So 
now, under the Collins legislation, a pharmacist can alert a customer 
if their copayment would cost more than paying out-of-pocket, as just 
an example.
  This puts a little bit of transparency into the whole process and 
lets your pharmacist help you as much as he can to save money. But 
there are rules that some companies have that you can't share that 
information.
  So along the lines of also hoping to save the consumer some money--or 
at least to educate the consumer on pharmacy practices and to have more 
transparency--Senator Durbin and I pushed for Senate passage of an 
amendment that supports existing Health and Human Services authority 
requiring drugmakers to disclose the list price of prescription drugs 
in direct-to-consumer advertising.
  It happens that the House of Representatives rejected our amendment. 
Nonetheless, the Secretary of HHS is moving forward with our concept to 
improve transparency by requiring companies to include these same drug 
prices in their direct-to-consumer advertising.
  Another example of where the President, through the Secretary of HHS, 
has, under present law, authority to move ahead--we wanted to let the 
Secretary know, through the Durbin-Grassley amendment, that we wanted 
to back him up in his efforts. Drug companies are already required to 
include possible side effects in their TV ads. So isn't it commonsense 
to add to that list price information to further improve consumer 
decision making? The more information patients and healthcare providers 
have to make decisions on costs and outcomes, it seems to me, the 
better off they are.
  Finally, I would like to say a word about another commonsense 
solution to high drug prices. For over 20 years, I have advocated for 
the safe reimportation of drugs from countries such as Canada. The late 
Senator McCain, along with Senator Klobuchar, introduced S. 92, the 
Safe and Affordable Drugs from Canada Act. I am a cosponsor of this 
bill, and I plan to work to get it enacted into law.
  In today's marketplace, there is a giant disconnect between consumers 
and the prices they pay for their prescription medicines. To many of my 
constituents in Iowa, it is just plain baffling why this can't be done. 
Americans have come to expect the best medicine when they need it most. 
We need to improve the marketplace so that it functions properly to 
lower drug prices and raise the bar on outcomes.
  Looking ahead, our Republican majority here in the U.S. Senate will 
keep up the momentum to deliver cost savings to the American people. On 
my watch, I will continue working across the aisle to lower drug 
prices, restore competition, and increase transparency in the 
pharmaceutical industry. I welcome the incoming Democratic House 
majority to join our efforts in behalf of the American taxpayers and 
consumers.
  As Americans count our blessings during this season of Thanksgiving 
and going into Christmas, we give thanks for the gifts of friends and 
family who gather together around these celebration tables. I am 
thankful for good health and the opportunity to serve Iowans. Along 
these lines, I will do my best to restore competition in the 
pharmaceutical market and to stop the gravy train that is taking 
taxpayers for a ride.
  I yield the floor.
  The PRESIDING OFFICER. The majority leader.

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