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

Hearing

One year ago today, April 30, 2014, the Energy and Commerce Committee embarked on an ambitious,
bipartisan goal -- to develop legislation that would bring the medical innovation cycle of discovery,
development, and delivery into the 21st century and speed better treatments and, hopefully, more cures
to patients who desperately need them.

Since then, this Subcommittee has held over a dozen hearings and roundtables to educate Members on
topics ranging from modernizing clinical trials, to personalized medicine, to digital health care, to
incorporating patient perspective into the development and regulatory decision-making process.
We heard from government, academia, patients, providers, manufacturers, and stakeholders from across
the spectrum. The consensus was clear. We can and must do more to help patients in need and to
maintain our nation's role as the biomedical innovation capital of the world.

Informed by the continued outpouring of feedback and constructive criticism from stakeholders across the
spectrum, we have worked tirelessly on a bipartisan basis to develop the second discussion draft that
was released earlier this week. While it remains a work in progress, it is the product of good-faith
negotiations and a significant step forward in this process.

While increasing accountability, this legislation would invest in the basic research so critical to equipping
our nation's best and brightest with the tools they need to discover the underpinnings of disease; it would
streamline the development of new therapies and technologies which has become increasingly
challenging and resource intensive; and it would foster a dynamic, continuously learning health care
delivery system.

Work continues on several complicated, yet critical issues, including the regulation of diagnostic tests and
telemedicine.

With respect to diagnostics, we remain absolutely committed to developing a modernized regulatory
framework for these innovative and increasingly important tests and services. Understanding this is a
particularly unique and complex endeavor, we look forward to working in a deliberative manner over the
coming weeks with Dr. Shuren and stakeholders to advance legislation.

On telemedicine, I continue to work with my colleagues in the Energy and Commerce Working Group on
Telemedicine toward a bipartisan proposal that will encourage the use of telemedicine services to
improve health care quality and outcomes, increase patient access, and control costs. I want to thank the
administration and CBO for their input and look forward to our continued collaboration moving forward.
On that note, I would like to specifically thank our three witnesses today for their assistance throughout
this process and their testimony today.

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