21st Century Cures Act Appears To Be On Verge Of Passage : Shots - Health News The House could vote Wednesday on a vast bill that stretches nearly a thousand pages and holds changes large and small for the National Institutes of Health and the Food and Drug Administration.
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Congress Poised To Pass Sweeping Law Covering FDA And NIH

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Congress Poised To Pass Sweeping Law Covering FDA And NIH

Congress Poised To Pass Sweeping Law Covering FDA And NIH

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AUDIE CORNISH, HOST:

Congress is poised to vote on legislation that could boost medical research and change the way the government approves new drugs and medical devices. It's called the 21st Century Cures Act. It's up for a vote tomorrow in the House, and it could move quickly in the Senate. As NPR's Richard Harris reports, the bill is raising hopes and concerns.

RICHARD HARRIS, BYLINE: The hope is expressed by people who have been pushing for more money for medical research. The National Institutes of Health budget has slipped by about 20 percent over the past decade in terms of buying power. The 21st Century Cures Act doesn't by any means make up for that, but it does include a hefty infusion of research dollars for some new high-profile projects. Ellie Dehoney at the advocacy group Research!America is happy to see a big boost for a new government program to speed cancer research.

ELLIE DEHONEY: The Cancer Moonshot is emblematic of the way our nation, I believe, should feel about medical progress. It should be a top priority, and we should be devoting more resources, more time and more of our intellectual capital to that goal.

HARRIS: The bill, nearly 1,000 pages long, also promises faster action on potential new drugs and devices. This is where some of the concerns come in.

MICHAEL CAROME: It is a massive bill that has scattered throughout a grab bag of goodies for the medical device and pharmaceutical industries.

HARRIS: Dr. Michael Carome is director of the Public Citizen Health Research Group. Some 1,400 lobbyists had a hand in the bill, so Carome says it's not all about helping sick people get better. He's concerned that some parts of the bill will allow drugs to be approved on thinner evidence than they now require.

CAROME: There's no doubt that patients would like to get treatments faster to the market, but they need to be assured that those treatments are indeed safe and effective for each of their marketed uses. And if we have insufficient evidence to demonstrate that, then that puts patients at risk.

HARRIS: The Food and Drug Administration has been accelerating drug approvals even without the new legislation. Drugs can be approved based on inferences that they work but without proof of a long-term benefit. Diana Zuckerman, who heads the National Center for Health Research, points to a study that found 18 of the 36 cancer drugs recently approved on this basis turned out not to help people live longer.

DIANA ZUCKERMAN: What's happening is we are flooding the market with medical products that don't work very well or that we don't know whether they work.

HARRIS: She has just published a new study showing that often these new cancer drugs don't even improve the quality of life of these cancer patients despite their soaring price tag. And she's concerned that the 21st Century Cures Act will make it even easier for drug companies to use this express lane for approval. Former FDA commissioner Mark McClellan agrees that the agency doesn't have a good track record following up on provisionally approved drugs.

MARK MCCLELLAN: A lot of follow-up studies have not been performed or have not been performed well because we just don't have good systems in place to learn about drugs once they are on the market.

HARRIS: But Dr. McClellan, who served in the George W. Bush administration, expects the new legislation to improve that situation. He understands why consumer advocates are concerned about changes to the FDA's rules, but he says via Skype that the FDA needs to keep up with evolving science and to factor in what patients themselves notice and value.

MCCLELLAN: It's time to give the FDA the tools it needs to make the most of those opportunities as well.

HARRIS: The 21st Century Cures Act could end up on President Obama's desk before the end of the year. Richard Harris, NPR News.

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