The House of Representatives today overwhelmingly passed a bipartisan bill designed to speed up the development and approval of new drugs and medical devices. To help make that happen, the bill would boost funding for the National Institutes of Health (NIH) and the US Food and Drug Administration (FDA).
The vote in the Republican-controlled chamber was 344 to 77.
The legislation, called the 21st Century Cures Act, enjoys support from the White House as well as medical societies such as the American College of Surgeons, disease groups such as the American Heart Association, and medical schools. However, a few groups in the healthcare field warn that the measure could allow unsafe, ineffective drugs and devices to reach the market in the name of expediency. A recent editorial in Modern Healthcare magazine dubbed it the “21st Century Quackery Act.”
One controversial measure would lessen the reliance on randomized clinical trials, considered the gold standard for assessing safety and efficacy. The provision would require the FDA to evaluate how evidence from “clinical experience” — that is, from observational trials, clinical registries, insurance claims, and FDA safety surveillance — might be used to approve a new indication for a drug already on the market. Likewise, in another broadening of scientific evidence, the bill would allow the FDA to consider registry data, studies published in peer-reviewed journals, and data collected outside the United States in its decisions on medical devices.
“The bill greatly benefits the pharmaceutical industry [and] medical device manufacturers,” said Diana Zuckerman, PhD, president of the National Center for Health Research, a think-tank focused on women, children, and families. “But by lowering standards for drugs and devices, it is likely to add billions to the cost of Medicare and all health programs without benefiting most patients. And it is an added burden on patients and physicians, because they need to decide which of the new treatments to try, without knowing if they are safe and effective.”
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