The 21st Century Cures bill advanced Thursday when The House Energy and Commerce health subcommittee sent the unanimously passed bill onto the full committee, which will address it next week.
The bill could potentially be enacted into law later this year.
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The legislation is designed to boost biomedical innovation through additional funding for the National Institutes of Health (NIH) and lowering the barriers for FDA approval. Although the measure was a bipartisan effort, some are still expressing concern – mostly about where the additional money will come from.
The bill includes $10 billion over five years in mandatory spending for the NIH. There will annual increases that by 2018 should have increased the agency’s budget by $5 billion.
How the bill will be paid for isn’t exactly clear yet, but there should be more answers next week, according to Chairman Fred Upton (R-Mich.). There is also concern about the FDA not getting more funding in this process.
According to The Hill, Rep. Diana DeGette (D-Colo.) said Thursday that if the FDA is not given more funding to aid in its approval of new cures “then we might as well not have the advances.”
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Some members of the subcommittee are concerned about a provision that states drug manufacturers would get six additional months of exclusivity for a drug with a new indication to treat a rare disease. Some Democrats think this could potential raise the price of such drugs and it isn’t necessary when looking to promote innovation.
Critics of the bill include recently departed FDA Commissioner Margaret Hamburg. She has warned that the bill could speed up the process too much.
“In the race for the newest treatment, we must remember the point that innovation doesn’t matter if the product doesn’t work,” she said in March during her final speech.
