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April 14, 2017 Comments (0) Views: 301 April 2017, Opinion, People, Pharma, Short Stories

The Cures Act: A Remedy for Slow FDA Approval?

Five local experts weigh in

Former President Barack Obama signed the 21st Century Cures Act last December, which increases funding for the National Institutes of Health by $4.8 billion over ten years, earmarks $1 billion for states to fight addiction, and provides an additional $500 million for the FDA. The bill was approved 94 to five by the Senate—an outlier in a partisan Congress. However, some are concerned that NIH funding is not guaranteed beyond the first year. In addition, the act gives the FDA more flexibility on the evidence it requires to approve drugs and devices. Here are a few takes on the new law.

 

cures-act-p-kay-coleman

“The NIH funding has been bad for many years. Researchers spend so much time trying to get funded, they don’t have time to do the science. I am thrilled that citizens, patients, and cancer survivors finally got our government to work in a bipartisan way to do more to fund this important work.”

—P. Kay Coleman, Chair, American Cancer Society California Division Board of Directors; Partner, FCB Partners LLC

 

cures-act-evan-snyder

“My biggest concern is that it will legitimize circumventing good scientific protocol by good scientific investigators, and there will be more pressure to do clinical trials without doing the background basic science. Before you try to fix something, you need to figure out what needs to be fixed, and we don’t know that for most diseases.”

—Evan Snyder, MD, PhD, Director, Sanford Children’s Health Research Center at SBP Medical Discovery Institute

 

cures-act-daniel-bradbury

“It’s a very good piece of legislation. One of the areas that needs more clarification is the level of data the FDA will accept for approval that’s not from clinical trials. They’re talking about using data from reviews of electronic medical records, but there’s no guidance around that.”

—Daniel Bradbury, Managing Member, BioBrit LLC, life sciences consultant and investor

 

cures-act-diana-zuckerman

“Over the past few years, the standard of an effective cancer drug has gotten much lower… The standards under 21st Cures would be lowered even further under the assumption that the FDA is way too burdensome and strict. The data is showing there are a lot of products on the market with no proof that they are beneficial. We have to have some kind of objective standard of effectiveness, and it can’t just be what 21st Cures says.”

—Diana Zuckerman, PhD, President, National Center for Health Research

 

cures-act-joe-panetta

“So far, it’s looking great. The two basic components are the increased funding for the NIH and the boost that the FDA is going to get, in terms of fast-track processes for taking drugs through to approval.”

—Joe Panetta, President and CEO, Biocom

 

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