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Critics Question Parts of 21st Century Cures Act

A biomedical research funding bill that was approved unanimously last week by the US House of Representatives' Energy and Commerce Committee is raising safety concerns, the Wall Street Journal reports.

The bill, called the 21st Century Cures Act, would increase funding for the National Institutes of Health by $10 billion over five years, starting in Fiscal Year 2016, and would establish an NIH Innovation Fund, with $2 billion a year for FY 2016 through FY 2020, as GenomeWeb has reported. The bill is expected to go for a full vote next month.

Provisions of the bill also aim to speed up the drug-approval process and could make phase III trials less common. Critics of the bill say this could lead to the sale of drugs and devices that haven't been fully vetted, the Journal says, including of needed new antibiotics.

For instance, the health advocacy group Public Citizen said in a letter last week to House members that parts of the bill "would undermine public health and threaten patient safety."

However, about a dozen public health groups welcome the provisions. "It is often not feasible for these drugs to be developed using traditional, large clinical trials," those groups said in a separate letter.

A spokesperson for the House committee majority tells the Journal that the bill "upholds the gold standard of safety and efficacy" and that it "seeks to break down barriers to further discovery and innovation while maintaining thorough safety standards."

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