21st Century Cures bill clears the House
Monday, July 13, 2015
Posted by: Angela King
The House passed legislation Friday that aims to speed the development of new drugs and medical devices by increasing health research funding and streamlining the approval process for new treatments.
The 21st Century Cures Act passed on a 344-77 vote, with most of the no votes coming from Republicans who opposed a provision in the bill making $11 billion in research funding mandatory instead of subjecting it to Congress’ annual appropriations process.
“This essentially took a good bill and turned it into another runaway government program,” said Rep. Scott Desjarlais, R-Tenn.
More than 700 organizations supported the bill, however, ranging from trade associations such as the Biotechnology Industry Organization to patient advocacy groups and universities.
The bill aims to streamline clinical trials for new drugs and devices by reducing paperwork requirements and allowing researchers to screen patients in advance to determine if their genetic predisposition make them good candidates for targeted therapies. The legislation also provides more regulatory certainty for developers of new medical apps that share patient data, and creates economic incentives for development of treatments for rare diseases.
In addition, the bill “takes takes important steps toward placing patients at the center of the drug development process,” said BIO President and CEO James Greenwood.
Supporters of the bill said the changes in the approval process for new drugs and devices — which now can take up to 15 years — won’t compromise patient safety.
But some experts aren’t so sure.
The legislation “could substantially lower the standards for approval of many medical products, potentially placing patients at unnecessary risk of injury or death,” contends a New York Times op-ed written by David Kessler, a former commissioner of the Food and Drug Administration, and two co-founders of the Treatment Action Group.
Now the debate on whether the benefits of this legislation are worth its risks moves to the Senate.
Source: Louisville Business First. http://www.bizjournals.com/louisville/news/news-wire/2015/07/10/house-votes-to-speed-drug-approval-process.html