[Congressional Record (Bound Edition), Volume 157 (2011), Part 5]
[Senate]
[Pages 6865-6867]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           PROFIT OVER HEALTH

  Mr. BROWN of Ohio. Mr. President, yesterday across this country, we 
celebrated Mother's Day, marking the contribution of mothers across our 
country. But 2 months ago, the health of tens of thousands of expectant 
mothers and their unborn children was threatened by a drug company 
putting profit over public health. Two months ago, there was justified 
public outrage that the cost of a drug hormone, progesterone, to 
prevent premature births went from approximately $10 a dose--20 doses 
are needed through the course of a pregnancy--to $1,500 per dose. The 
entire course of the 20-week treatment, therefore, was about $200 three 
months ago. Two months ago, it went to $30,000--$200 to $30,000.
  This was once an affordable, common treatment to help women facing 
high-

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risk labor. I visited Toledo Children's Hospital, MetroHealth in 
Cleveland, and St. Elizabeth's Health Center in Youngstown to hear 
directly from patients and physicians and hospital executives about how 
the outrageous price increase affects them. Patients explained what it 
was like to overcome a previous miscarriage and rely on this 
progesterone to carry to full term today. Physicians and public health 
advocates explained the risk to women and children's health if the 
therapy were no longer affordable and accessible. Hospital 
administrators and State Medicaid directors worried what such an 
exorbitant increase would mean to already-stretched budgets.
  Meanwhile, several colleagues and I began to ask questions about how 
and why the increase happened in the first place. We are concerned 
about how companies, private companies, abuse the FDA approval process 
or manipulate existing rules to shortchange consumers while those 
companies reap massive windfall profits. That is especially so because, 
in addition to affixing such a high cost to the drug, this company, KV 
Pharmaceuticals from St. Louis, sent a letter threatening a cease and 
desist order to compounding pharmacies--those pharmacies that actually 
make their own progesterone, in this case--a cease and desist order to 
prevent these pharmacies from producing it, further solidifying KV 
Pharmaceutical's monopolization in the marketplace. All the while, 
pregnant women are left without the critical medicine their doctors 
prescribe for them, and either taxpayers foot the bill, insurance 
companies foot the bill, driving the price up, or women simply do 
without, increasing the number of miscarriages, increasing the number 
of low-birth-weight babies, increasing the cost to taxpayers, and 
increasing the heartache in mother after mother and father after 
father.
  Fortunately, in an unusual response--unusual in the sense that this 
case was so dramatically outrageous and unbelievably greedy on the part 
of KV Pharmaceutical executives--the FDA did something it doesn't 
normally do: It asserted its authority and made clear it would not 
enforce the cease and desist order. What was KV's response after the 
public outrage, after the refusal to enforce the cease and desist 
order, therefore allowing the pharmacies to keep producing the 
progesterone? It reduced the price from $1,500 a dose--remember, it was 
$10 per dose as recently as 3 months ago. They take a shot every week 
for 20 weeks during the pregnancy. It was $10 a dose, and they raised 
it to $1,500. But do you know what they did after the FDA and a small 
number of Democratic Senator's pushed them, embarrassed them in public? 
They brought the price down to $690 a dose. It went from $10 when 
compounding pharmacies were doing it, to $1,500 when they thought they 
could get away with it, to $690--as if they thought they were doing 
America's women a favor. That means instead of it being $30,000 for the 
whole cost of the pharmaceutical, the 20 doses, it would be about 
$15,000. What a bargain. On top of that, they did what companies whose 
hands are caught in the cookie jar always do: They hired high-powered 
Washington, DC, lobbyists to fight for their rights, this exclusivity 
for this drug, trying to prohibit the critical work of compounding 
pharmacists.
  I agree with drug companies; generally they need to recoup their 
investment. I want America's drug companies to do the boldest, most 
innovative, most progressive research in the world, and I want them to 
make a profit doing it so they can afford to do it and keep doing it. 
They should reflect the amount of R&D to bring drugs to market, the 
cost of their manufacture, the cost of their distribution, but in the 
case of this progesterone, the case of this pharmacy compound, 
taxpayers--in this case, through the National Institutes of Health--
funded the initial research and continue to fund critical research on 
premature births. KV Pharmaceutical didn't do the research; they bought 
the exclusive rights to a monopoly by reimbursing another company--
contracting with them--I believe that actually conducted the clinical 
trials and incurring the costs needed for FDA approval.
  Something is very wrong when a company with limited R&D investments 
can grossly overprice a drug that in its absence virtually guarantees 
an increase in premature births.
  Think of the greed involved here. They paid some number of millions 
of dollars to do a clinical trial, which was a good thing. They then 
brought the price from $10 to $1,500--times 20, again, with the number 
of doses people need in their treatment. With an initial investment of 
less than $200 million, the first year they would have reaped over $3 
billion in revenue. Those are the kinds of numbers they were operating 
on, as if that is fair.
  When a company used taxpayer-funded research to produce a drug so 
important that it reduces infant mortality and birth defects, that 
company should also take on the responsibility for pricing it in a 
reasonable manner. But prices should never be inflated, particularly on 
a public health drug where this company did not do the basic 
foundational research; all it did was pay for clinical trials that did 
not prove much more than we already knew. A company should never be 
allowed to inflate prices of a public health drug to reap these kinds 
of massive profits, nor should the FDA approval process ever be 
manipulated to achieve that same end, which it was.
  While balancing the benefits of corporate profit--and I understand 
the balance, and I want the companies to continue to invest and move 
ahead--while it can be challenging balancing corporate earnings and 
societal benefits, we can't lose sight of our responsibility to make 
innovative medicines available and accessible to as many people as 
possible.
  I would like to close with a story about why all this matters. Not 
too long ago--last month, I guess it was, early April--I was in Port 
Columbus International Airport about to fly to Washington when Karen 
Turano, whom I never met before, walked up to me to share her story. 
She has since e-mailed after our discussion where she talked about this 
drug, and she sent me this letter:

       I met you at the Columbus airport with my husband Thad and 
     our 17-month-old son Ryker. Again, I just wanted to say thank 
     you for the work you are doing to make the progesterone shots 
     affordable again.
       Our first son, Tyler, was born August 18, 2008 and passed 
     away the next day, August 19, 2008. I prematurely went into 
     labor at 24 weeks and had an emergency C-section. Tyler was 
     born at 9:59, weighing 1 pound 10 ounces.
       Thad went to be with [my son] since I was recovering from 
     surgery. He called me early the next morning and told me the 
     worst news a new mother could hear: There was nothing more 
     that could be done and that Tyler would pass away. My mother-
     in-law took me to see and hold Tyler for the first and last 
     time in his precious life. It was devastating.
       Thad and I have since worked with public health advocates 
     to raise awareness on ways to prevent premature births--while 
     following doctor's orders to wait 6 months before we tried 
     again.
       After I became pregnant with Ryker, I was monitored closely 
     and started the progesterone shots at 16 weeks which 
     continued through 36 weeks.

  She had these shots through 20 consecutive treatments, once a week 
for 20 weeks.

       I am convinced that these shots allowed me to carry the 
     pregnancy to term.

  Interrupting the letter for a moment, understand that when a doctor 
sees someone like Karen who has had a pregnancy like she had where a 
baby was born that prematurely, that doctor understands that a 
progesterone like this progesterone we are talking about can make a 
huge difference in her carrying her baby to full term.

       Ryker was born at 38 weeks on October 30, 2009, my 
     Halloween baby. My husband is a Columbus firefighter and I am 
     an attorney practicing in workers' compensation. We look 
     forward to more children in the near future, but the cost of 
     this shot concerns us greatly. We have experienced the 
     horrible pain of losing a child. No mother or father should 
     have to go through this pain.

  She writes, signed:

       Sincerely, Karen, Thad, Ryker and Tyler Turano.

  Today is Karen's birthday, coincidentally. She celebrates with her 
son Ryker and husband Thad and other family and friends--and she does 
with Tyler in her memory. I thank Karen

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for sharing her story and the patients in Toledo, Cleveland, 
Youngstown, and across our Nation and State who have spoken about this, 
who deserve the affordable and accessible treatment they need. I am 
optimistic we can continue to find ways to ensure that the majority of 
women in this country will still have access to affordable versions of 
this critical lifesaving injection. It should not take public outrage, 
it should not take congressional action, it should not take the FDA 
altering a policy it normally doesn't alter for a company to do the 
right thing.
  Mr. President, as you know, with the unemployment in your State and 
the unemployment in my State and the problems we have as a nation on so 
many levels, this is particularly outrageous because this progesterone 
is a public health pharmacy compound that has worked and meant many 
more women will have safe births with growing, healthy children, 
contrasted with, if they do not have the opportunity to get this 
progesterone at a reasonable rate, at a reasonable price, we know what 
happens then. But rest assured, we will keep up the outrage, and we 
will continue to move through Congress, if that is what it takes, to 
get progesterone at an affordable price to America's women.
  It is an outrage what KV Pharmaceuticals did. I applaud the FDA for 
changing its policy to make it more accessible.
  I ask KV Pharmaceuticals to again come to the table. Instead of 
lobbying Congress to get their way and make a huge amount of money on a 
relatively small investment, I ask them to come to the table and work 
with us so we can make this very important pharmacy compound accessible 
to all American women whose doctors prescribe it to them.
  I yield the floor.

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