By Steven Ross, Modern Healthcare
July 10, 2015
In a rare act of bipartisanship, House members voted 344-77 on Friday in favor of the 21st Century Cures Act, which supporters say will speed the development and regulatory approval of medical breakthroughs. Critics say that speed would come at the expense of patients’ safety.
The legislation would provide an additional $9.3 billion in mandatory funding over the next five years to fund the National Institutes of Health and establish a Cures Innovation Fund to support work toward breakthroughs in biomedical research. It also provides $550 million in added funding to the Food and Drug Administration over the same period.
Supporters of the legislation say it will remove regulatory roadblocks in the FDA review process for medications and medical devices.
It has received strong support from both the Pharmaceutical Research and Manufacturers of America and the Advanced Medical Technology Association. The industry groups argue that the bill would make the review process more efficient and less cumbersome, reducing the costs of bringing a product to market and ultimately lowering the cost of those therapies for patients. […]
The bill also has its critics, who say it would loosen FDA review standards and allow therapies to be sold before enough clinical data is gathered to determine whether they are safe and effective.
“What they’re doing is that they’re replacing the burden of proof for drug companies and device companies with a burden of uninformed decision-making for patients and doctors,” said Diana Zuckerman, president of the National Center for Health Research, a Washington D.C.-based not-for-profit patient-advocacy organization. “You’re replacing the burden of proving that your product works with the burden of having expensive products on the market that may or may not work.”
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