Consumer groups are cautioning against approval of a medical innovation bill moving toward passage in the House and Senate, warning that it could endanger patients by lowering standards for the approval of new drugs.
Groups like Public Citizen and the National Center for Health Research say the bill, known as 21st Century Cures, would unacceptably lower safety standards at the Food and Drug Administration.
Proponents of the measure, which has been the subject of months of bipartisan negotiations, say it will speed up the FDA’s approval of life-saving new drugs and devices while ensuring that regulatory standards are still strong enough to ensure safety.
The House is slated to vote on the bill Wednesday, and the Senate is likely to follow soon. A new bill was released Friday night, though it is still undergoing tweaks.
The measure, which is being combined with a less-controversial mental health bill, is a priority for Republican leadership before Congress leaves for the year.
The consumer groups argue that Democrats are being won over by $4.8 billion in new funding over the next decade for research at the National Institutes of Health. Without this sweetener, they argue provisions loosening FDA regulations would never pass muster on the left. […]
However, the consumer groups opposed to the bill point to provisions that would allow the use of more “real world evidence” of a drug’s effects, which is a lower standard than more rigorous randomized clinical trials.
The groups, which have long been opposed to the measure, also warn against provisions allowing for companies to submit summaries of data about a drug, rather than the full data set, when seeking to expand the areas for which a drug is approved.
The bill would also create a faster approval process for “breakthrough” medical devices, which the groups warn would lead the FDA to rush the process.
Diana Zuckerman, president of the National Center for Health Research, a think tank, said overall the FDA provisions in the bill “make it much easier to get FDA approval for things that may not work and may not be safe.”[…]
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