Conservative and Progressive Experts Join Forces to Expose Under-the-Radar Consequences of 21st Century Cures Act

PR Newswire

November 22, 2016

Experts from opposite ends of the ideological spectrum were united over concern about the 21st Century Cures Act at an emergency briefing in the U.S. Senate yesterday. While highlighting different problems, they agreed that Congress should not rush a closed-door negotiated version of the bill during the lame-duck session.

We are in the midst of nationwide concern and discussion about healthcare issues and how best to handle them. “We each recognize there are deep problems within the FDA that have resulted in dangerous drugs and medical devices on the market,” said panelist Jonathan Emord, Esq. A majority of Americans do not think the FDA is doing a good job of regulating safety and effectiveness, according to a poll examining public opinion on the 21st Century Cures Act and the similar Senate package, conducted by Stat and Harvard TH Chan School of Public Health.

The FDA has a medical device approval pathway referred to as 510(k), which allows for device approval without standard clinical trials. Under FDA practices, the vast majority of medical devices are now approved under the 510(k) process within 90 days, according to panelist Dr. Diana Zuckerman, president of National Center for Health Research. She added, “Over a 1-year period, almost half a billion 510(k) approved devices were recalled as high-risk, some having caused death.”

The majority of Americans oppose measures included in the 21st Century Cures Act, that change standards in order to speed the approval of new drugs and devices, according to the Stat and Harvard poll. […]

 

Dr. Zuckerman provided data on the large number of drugs that showed promise in early stages of review, only to be proven ineffective or worse in later stages. This datum is key to concerns about a provision in the bill that allows for approval based on early stage indicators. […]

 

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