Congress Says ‘Yes’ to Fast Track FDA Approvals
Posted in News on 12.9.2016
Last week Congress passed legislation addressing questions of healthcare regulation and public health funding. The 21st Century Cures Bill was able to gain easy approval in both the House and Senate because it contains provisions that appeal to both sides of the aisle and to various industry and public interest groups.
One of the most salient features of the bill is its loosening up of current FDA standards for approving drugs and medical devices, naturally drawing ire from critics who are concerned that relying on less rigorous standards of evaluation (using types of studies other than the gold standard of clinical trials and using fewer studies to make a determination) will result in ineffective or unsafe products on the market. Advocates of the bill, including representatives from industry, say the new standards will streamline what is currently a bureaucracy-laden approval process and bring beneficial or potentially life-saving treatments to patients more quickly.
Despite lack of consensus around parts of the bill pertaining to FDA deregulation, other features written into the bill, including increased funding for the National Institutes of Health (NIH) and $1 billion earmarked for prevention and treatment of opioid addiction, helped it to gain widespread support. Read the full article here to see what Alosa Health founder Dr. Jerry Avorn has to say.
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