July 3, 2015

“21st Century Cures Act”: Much Needed Legislation

By Jeff Briggs
Colorado Democrat Diana DeGette is one of the main sponsors of the 21st Century Cures bill

Colorado Democrat Diana DeGette is one of the main sponsors of the 21st Century Cures bill

“An ambitious bipartisan plan to accelerate medical innovation in the U.S. is moving ahead in a Congress famous for political gridlock,” writes The Lancet's Washington correspondent Susan Jaffe.

After a 12-year slide in federal funding for basic medical research, the Energy and Commerce Committee of the House of Representatives decided to take on that challenge by launching an initiative called 21st Century Cures. Fred Upton, a Republican from Michigan, and Diana DeGette, a Democrat from Colorado, co-authored the legislation. In May, the “21st Century Cures Act” was passed unanimously by the committee, 51-0, and now goes before the full legislature.

From the committee and from all who have testified before Congress, the message has been the same: our current framework for discovering, developing, and delivering safe and effective medicines and medical devices to patients is too slow, too expensive, and too cumbersome.

No one is thrilled with the way new treatments, new drugs and new medical devices reach the patient in the United States — not members of the medical community like Mayo Clinic, not the National Institutes of Health (NIH), not physicians, not pharmaceutical companies, not regulators at the U.S. Food and Drug Administration (FDA), and certainly not patients desperately in need of new therapies.

The process is hugely expensive and incredibly slow. According to the Tuft's Center for the Study of Drug Development, the average cost of bringing a new prescription drug from lab to market now tops $2.5 billion and takes more than 10 years.

The new legislation seeks to change this and covers three broad areas: discovery, development, and delivery.

The NIH, the world’s largest funder of biomedical research, stands to benefit, as the act would direct an addition $10 billion dollars to the funding agency over the next five years. That would enable the NIH to accelerate research into more personalized approaches to treating cancers and genetic disorders.

NIH Director Francis Collins, M.D., Ph.D., believes this legislation is a good way to get the “NIH back on track.

“This is how we’re going to solve health problems,” Dr. Collins said, in an interview with The Boston Globe at the recent Biotechnology International Organization’s annual convention. “This is also, by the way, a very good investment in the economy. And it’s a good opportunity to shore up America’s leadership in this space, which has been slipping a bit.”

Some have argued, however, that it’s still not enough to catchup on over a decade of neglect for funding of biomedical research. Senator Elizabeth Warren, a Massachusetts Democrat, said, “A few billion dollars in temporary funding will not solve a decade of neglect, much less build a future that we need.”

Reps. Upton and DeGette launched the bipartisan 21st Century Cures initiative a year ago with this call to arms: “Health research is moving quickly, but the federal drug and device approval apparatus is in many ways the relic of another era”, its mission statement says. “We have dedicated scientists and bold leaders at agencies like the NIH and the FDA, but when our laws don't keep pace with innovation, we all lose.”

We couldn’t agree more.

Here is a link to Susan Jaffe’s excellent story in The Lancet: 21st Century Cures Act progresses through US Congress

Here is a link to the U.S. Energy and Commerce Committee’s “21st Century Cures: What You Need to Know,” which includes links to the full text of HR 6, the 21st Century Cures Act, and other important information.

If you, like us at the Center for Individualized Medicine, believe it’s time to properly fund biomedical research, please let your voice be heard.

U.S. Representatives Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) discuss the 21st Century Cures Act.

U.S. Representatives Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) discuss the 21st Century Cures Act.


Tags: 21st Century Cures Act, center for individualized medicine, FDA, NIH, Precision Medicine, Rep. Diana DeGette, Rep. Fred Upton, Susan Jaffe, Uncategorized

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