Senate panel drafts bill to speed cures

April 29, 2015 in Medical Technology

After a year of listening to patients, innovators, researchers, providers, consumers and regulators, Energy and Commerce Committee leaders from both parties have released a draft bill aimed at furthering its work on the 21st Century Cures initiative.

On April 30, exactly one year to the day since full Committee Chairman Fred Upton, a Republican from Michigan, and Rep. Diana DeGette, a Democrat from Colorado, launched the initiative, the Subcommittee on Health will hold a hearing to review the draft legislation.

The impetus, as described by Upton, is to find cures for diseases that don’t yet have them – and there are many.

As FasterCures Executive Director Margaret Anderson put it at the committee’s roundtable in May 2014. “There are 7,000 known diseases. We have treatments for only 500 of them. We have work to do.”

[See also: Senate panel urges medical innovation.]

The discussion draft legislation the Congressional panel released April 29 includes provisions to:

  • Incorporate the patient perspective in the discovery, development, and delivery process.
  • Increase funding for the NIH, both through reauthorization and $10 billion over five years in mandatory funding, starting in FY 2016.
  • Foster development of treatments for patients facing serious or life-threatening diseases.
  • Repurpose drugs for serious or life-threatening diseases and conditions.
  • Modernize clinical trials.
  • Break down barriers to increased collaboration and data sharing among patients, researchers, providers, and innovators.
  • Help the development of personalized and precision medicines so the right patient can receive the right treatment at the right time.
  • Provide for continued work in the telehealth space.
  • Advance a truly interoperable health care system.
  • Provide clarity for developers of software products used in health management and medical care.

[See also: Telehealth progress may stall in DC.]

The committee has held eight hearings, issued several white papers, and committee members have hosted more than two-dozen roundtables across the country to generate ideas for the initiative. Among the many participants in the panel’s information-gathering roundtables were C. Martin Harris, CIO of the Cleveland Clinic, Sean Hogan, vice president for healthcare at IBM; Jonathan Bush, CEO and president of athenahealth, Mark Blatt, worldwide medical director of Intel; Joseph M. Smith, MD, chief medical and science officer at West Health and Paul Magelli, CEO of Pervasive Health.

Working on the draft legislation were Upton, DeGette, full committee Ranking Member Frank Pallone, Jr., a Democrat from New Jersey; Health Subcommittee Chairman Joe Pitts, a Republican from Pennsylvania; and Health Subcommittee Ranking Member Gene Green, a Democrat from Texas.

“We’ve done things differently with 21st Century Cures, taking our time to listen and solicit feedback from every corner of the health care innovation infrastructure, the leaders said in a press statement. “It is because of this transparent, collaborative process that we are now ready and excited to take the next step in boosting research and delivering hope to patients and families all across the country. The ideas outlined in this draft represent a year of listening and working together to develop a product that we believe will truly help patients and bring our health care innovation infrastructure into the 21st century.”

Kathy Hudson, MD, deputy director for science, outreach, and policy at the National Institutes of Health, Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the Food and Drug Administration, and Jeff Shuren, MD, director of the Center for Devices and Radiological Health at the FDA will testify at the hearing Thursday.

Learn more about 21st Century Cures online here.

The draft legislative text is available online here.

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