Medical devices and drugs could reach your hands faster if a massive House bill is approved, but leading experts question whether they will be safe.
Two medical experts are concerned several provisions in the bipartisan 21st Century Cures Act may unnecessarily speed up product approvals at the expense of thorough reviews for safety and effectiveness.
“Changing the Food and Drug Administration’s standards to get more drugs on the market is inherently risky to patients,” Dr. Aaron S. Kesselheim, associate professor of medicine with Harvard Medical School, told the Washington Examiner.
Kesselheim, with Harvard professor Dr. Jerome Avorn, wrote an editorial in the New England Journal of Medicine that criticizes parts of the measure.
The bill was unanimously approved by the House Energy and Commerce Committee last month and awaits a vote from the full chamber. That vote could happen as early as next month, Committee Chairman Rep. Fred Upton, R-Mich., and Rep. Diana DeGette, D-Colo., told the Examiner.