[Ip-health] DeLauro and Colins on March-In, and reasonable terms earlier this year

Jamie Love james.love at keionline.org
Wed Dec 14 07:17:53 PST 2016


>From this hearing:



DRUG COSTS Ms. DELAURO. Taxpayers provide more than about $30,000,000,000
annually for NIH’s research. Dr. Collins, you have said that NIH conducts
the basic science that ‘‘fosters innovation, ultimately leads to effective
ways to treat complex medical conditions.’’ And yet, in so many cases,
taxpayer-funded research leads to drugs that are sold back to the taxpayers
at exorbitant prices.

Example. UCLA led to a patent for Xtandi, a drug to treat prostate 26
cancer. The drug now costs patients $129,000. The same costs patients in
other countries about a third of that amount.

Look, I realize the pharmaceutical companies invest their resources. They
bring a new drug to market. They should profit from that innovation. But
what I want to know is why U.S. taxpayers are getting gouged for drugs that
wouldn’t exist without the significant investment of U.S. taxpayers.

Can you better explain why U.S. taxpayers are paying for biomedical
research on the front end and paying exorbitant prices at the back end? And
I will just say that 50 of my colleagues and myself have sent a letter to
you and to Secretary Burwell, requesting that the NIH and HHS assert
March-in rights when taxpayer-funded research leads to a patented product
that is not available to the public on reasonable terms.

What are reasonable terms? A drug shouldn’t cost $129,000 for people to get
access to it.

Dr. COLLINS. Well, I know this is a topic of great interest, and well it
should be. And certainly, my heart goes out, as all of us do, to patients
who are in need of a therapeutic which is outside of their financial means
to be able to gain access to, and that really ought to be the thing that
drives us trying to come up with better solutions.

I would say with regard to March-in rights, we read the letter carefully.
You saw the response from Secretary Burwell. NIH does, in fact, have the
ability to march in if reasonable terms are not being met and if we have
intellectual property that is attached to that particular product.

Ms. DELAURO. What is a reasonable term?

Dr. COLLINS. Well, that is very much where it gets down to the
nitty-gritty, doesn’t it? And we have looked at that situation several
times in the past, and have not felt like we reached reasonable terms. But
we are totally open to considering that on a case-by-case basis, and we
will be glad to do that with other products that are brought forward for
our consideration. We get it that this is a serious issue.

Ms. DELAURO. And let us have further conversation. And I have gone over my
time. I thank you, Mr. Chairman.


Later in the same hearing, DeLauro says that a va​ccine for Zika should be
affordable, relevant since the NIH and the Army are licensing Zika vaccine


​Ms. DELAURO. I would like to continue this conversation to look at breast
cancer particularly. And I might just ask you to take a look at the Wall
Street Journal this week. Bristol, and this is Bristol-Myers Squibb bets
against Precision Medicine. I would ask you to take a look at it and tell
us, you know, what Bristol-Myers Squibb is thinking about or talking about
when we are trying to move in this direction.


Ah, I have got 4 seconds left. La-da-da. All I will just say is, and this
is to Dr. Fauci, if, one, I want to make sure that any vaccine that we deal
with for Zika is going to be available and affordable for people. This is
this reasonable terms issue. But secondly, I will just offer my view. I
think it is critical for us to deal with supplemental emergency resources
in order to address this issue and this problem. You are right. I will tell
you that 46 we are now sending blood products to Puerto Rico in response to
a Zika outbreak. What happens when we are looking at a blood supply that is
potentially going to be difficult or people are not going to understand the
safety of a blood supply with regard to Zika, and what kind of problems
that is going to cause here in the U.S.?

And let me just tell you, American women are not going to—they are going to
be outraged if we are not doing something about them and about their
ability to be pregnant and to bring a child to term. So thank you for the
great work that you are doing in this area. I have another question, but
that is okay. [Laughter.]

Mr. COLE. Well, I am not sure that was a question, but it was——

Ms. DELAURO. Genetically modified mosquitoes. Are they—is it— genetically
modified mosquitoes? Mr. COLE. I am going to ask the gentlelady to take
that one for the record. Ms. DELAURO. Okay. All right. Thank you. ​

James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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