21st Century Cures effort gains steam

May 2, 2015 in Medical Technology

One year to the day that Rep. Fred Upton and Rep. Diana DeGette launched the 21st Century Cures initiative, the House Energy and Commerce Subcommittee held a hearing Thursday to discuss draft legislation that in the future could mean more cures for more diseases for people across the country.

As experts have pointed out, there are 7,000 known diseases, and cures for 500 of them. The goal of the 21st Century Cures initiative is to change that ratio significantly.

Upton, a Republican from Michigan, chairs the committee. DeGette, a Democrat from Colorado, is a ranking member.

During the hearing, Upton showed a photo of Brooke and Brielle Kennedy, of Mattawan, Michigan. He said they served as an “inspiration for the the 21st Century Cure initiative.” The girls are six and seven years old, and they live with the rare disease known as Spinal Muscular Atrophy, or SMA, for which there is no known cure.

Over the past year, the committee has solicited ideas from patients and experts across the country. Among those joining the discussion – there were eight hearings – have been Martin Harris, CIO of Cleveland Clinic; Jonathan Bush, CEO of athenahealth; and Joseph M. Smith, MD, chief medical and science officer at West Health. The bipartisan discussion draft released Thursday is the product of this yearlong effort.

[See also: House panel drafts bill to speed cures.]

At the hearing Thursday, Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, and Jeff Shuren, MD, director of the Centers for Devices and Radiological Health, testified on behalf of the Food and Drug Administration saying they were pleased the committee had included provisions in its draft legislation to incorporate patients’ voices into FDA’s decision-making regarding the benefits and risks of new products.

Kathy Hudson, MD, deputy director for science, outreach and policy at the National Institutes of Health, said: “All of us at NIH believe passionately in this mission, and are dedicated to the pursuit of knowledge and, ultimately, cures.

“With your support,” she added, “we can anticipate a bright future of accelerating discovery across NIH’s broad research landscape, from fundamental scientific inquiry to translational and clinical research.”

Former FDA Commissioner Andrew Von Eschenbach, wrote in a statement Upton read at the hearing that he viewed the potential of the draft proposal “to be one of the most transformational pieces of legislation that has come along since the National Cancer Act of 1971.”

[See also: FDA must make smarter use of big data.]

“This committee’s ambitions stretch across the century and so we want to do everything we can to improve the process of discovering, developing and delivering new biomedical advances,” DeGette said.

Subcommittee members discussed the progress that has been made over the past year, reflected in the discussion document, and the work that remains to getting this bill to the president this year.

“Work continues on several complicated, yet critical issues, including the regulation of diagnostic tests and telemedicine,” Health Subcommittee Chairman Joe Pitts, R-Penn., said.

Learn more about 21st Century Cures online hereThe draft legislative text is available online here.

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