Passage seemed likely Friday despite warnings from consumer organizations and others that the measure would weaken government safeguards against risky or ineffective products.
The measure, approved on a 344-77 vote, would provide $1.75 billion in additional annual funding to the Bethesda-based NIH in exchange for the agency’s placing a greater emphasis on young scientists – who often struggle to win grants – and requiring more accountability in grant making.
“Hopefully it will in fact trigger a similar reaction in the Senate, where families know that there really is hope”, Rep. Fred Upton, R-Mich., chief author of the bill with Rep. Diana DeGette, D-Colo., said of the lopsided House vote. Pressed by industry and patients¿ groups, the House is nearing approval of a bipartisan bill that would speed federal approval of drugs and medical devices and boost biomedical research.
“The strong bipartisan support for the Cures Act in the House, together with broad support from the Obama Administration, are strong indications that the Senate will approve the Cures Act with small changes”, said Ross Muken, an analyst at Evercore ISI, in a research note. There is not yet a Senate version.
Upton has been conducting hearings all over the country, including one in at the new WMU Homer Stryker School for Medicine, to gather input on how they can get the regulatory and approval process up to speed with advances in research.
Supporters said that with medicine rapidly creating new treatments, it was time to modernize how the federal Food and Drug Administration assesses the safety of new products and allows their use by patients.
By 281-141, the House rejected an amendment by Brat under which the research money would not be guaranteed.
Other provisions would let regulators use shorter studies with fewer people as they decide whether drugs and devices are safe. New uses of existing drugs could be based partly on case studies and other processes that are less rigorous than traditional clinical trials. Producers of existing drugs would get an extra six months of protection from competition if their drug is approved for use against rare diseases.
Daniels welcomed the House’s passage of the bill as an important step in addressing dwindling funding for research.
The program would be paid for with the sale of 80 million barrels of crude oil from the Strategic Petroleum Reserve (SPR) over eight years. Another $2.5 billion would come from trimming federal Medicaid reimbursements to states buying certain medical equipment.
Procedures would be streamlined for approving some new antibiotics and medical devices considered breakthrough technologies.
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