Hearing of the House Health Subcommittee of the Energy and Commerce Committee - Legislative Hearing on 21st Century Cures

Hearing

Thank you Chairman Pitts. And let me thank Chairman Upton, Ms. DeGette and Ranking
Member Green. Today's hearing will examine a draft released yesterday that is the result of
months of discussions. It has changed significantly from the draft the Chairman released earlier
this year. While it is by no means perfect, it does reflect hard work by staff, true collaboration
between Republicans and Democrats, stakeholders, and the Administration and I am hopeful we
can bring this legislation to a successful conclusion.

Let me also thank HHS for the expert advice and help along the way. I know how many
resources have been spent on this effort as well, and this draft is a better product because of their
guidance.

Now I would have liked Members and their staff, and our witnesses, to have had more
time with the draft before a legislative hearing. The ambitious timeline has been a challenge. I
want to be clear that I am committed to ensuring that every Member is comfortable as this
process moves forward so that a final product gains broad support.

There are a large number of policies in this draft -- and not a lot of time to cover all of
them. But let me highlight just a few things.

Most notable in the new draft, and the one that I am most proud to see, is $10 billion in
mandatory funding for NIH over the next five years. It also includes a $1.5 billion increase in
NIH discretionary authorization over the next three years. This is a real win for researchers,
patients and industry alike. I believe federal funding is the foundation of our biomedical
ecosystem and is one of the most promising ways to spur economic prosperity and treatments
and cures for the 21st Century.

While this a great development, I hope that we can also ensure that FDA has the needed
resources to implement the many additional policies put forth in this draft. We cannot divert
already scarce resources nor impede the progress FDA has already made to advance the
development and review of medical products.

We also need to ensure that policies in this draft do no harm. I have said all along that
broadly extending drug exclusivity will not solve the problems 21st Century Cures sets out to
address. So I am glad to see that this new draft includes placeholder language for a much more
tailored approach at solving a targeted problem. We are going to continue discussions on how we
can incentivize development of a narrow class of drugs that have been abandoned because of
inadequate remaining patent life. Dr. Collins has spoken about the need to provide limited
additional exclusivity for drugs that have been found to be safe in clinical trials. Even though
they failed the trials for effectiveness, it may be possible to repurpose them for a different
indication or for a different population for which they may be effective. If such drugs fill an
unmet medical need for treating a serious or life threatening disease, it may be appropriate to
provide companies with limited additional exclusivity for companies to spend the resources
needed to determine if they work. I appreciate the Chairman's commitment to me to continue to
discuss this policy and ensure that it is targeted only to where it is needed.

Mr. Chairman, with the hard work of staff, I believe we have come a long way. However,
there are other complicated policies, like interoperability and telehealth, which still need
thorough vetting and further consideration.

As I've said since I became Ranking Member, I am serious about finding common
ground on important issues. True bipartisanship is critical to achieving successful and broadly
supported policies. I am confident that this much improved collaborative process can continue.
There is still much more work to be done, but today's hearing is an important step and I look
forward to our continued partnership on this initiative.

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