Opponents of the 21st Century Cures Act, which is intended to accelerate the transfer of scientific advances in genetics into treatment for patients, say the legislation will threaten patient safety by easing FDA rules intended to protect patients from unproven therapies, according to Medical Economics.
Critics argue looser FDA rules will result in drug approvals without the level of rigorous testing currently required.
The legislation "would lead to less effective drugs being put on the marketplace," James Rickert, M.D., president of the Society for Patient Centered Orthopedic Surgery in Bloomington, Indiana, told the publication. "People are always looking for new and better treatments but new and better treatments that are not properly vetted come with considerable risk," he says.
FierceHealthIT has reported similar concerns from doctors who say that new drugs and medical devices will be less safe and effective and cost more, and that the bill sacrifices long-term value to public health.
The bill was passed by the House of Representatives in July and the Senate is supposed to take on the legislation in early 2016.
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