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 The bill, known as the 21st Century Cures Act, requires the Food and
Drug Administration to incorporate patient experience into its
decision-making, streamline its review of drugs for additional uses,
and consider more flexible forms of clinical trials.
The bill, developed by the House Energy and Commerce Committee was
spearheaded by Republican Congressman Fred Upton and Democrat Diana
DeGette. Upton's goal is for the bill to be voted on by the full
House in June. A parallel measure is being developed in the Senate.
Patient advocacy groups cheered the bill. Ellen Sigal, chair of the
Friends of Cancer Research, said it "creates a more cohesive,
efficient, effective and patient-centered research and regulatory
system."
Some critics fear aspects of the bill will weaken the FDA's ability
to restrict marketing of drugs for unapproved uses and potentially
lower safety and efficacy standards by relying on less rigorous
clinical data.
The bill would increase funding to the National Institutes of Health
by $10 billion over five years. It would also boost FDA funding by
$550 million over the same period. An official cost of the
legislation is expected to be released within the next few weeks.
After last-minute negotiations lawmakers agreed to pay for the
legislation using a variety of offsets including the sale of eight
million barrels of oil for eight years from the Strategic Petroleum
Reserve, bringing in around $5.2 billion.
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Offsets would also include certain changes in government payments to
insurance companies, and a reduction in Medicaid payments for some
medical equipment.
The bill would exempt FDA user fee programs - funding the agency
receives from industry to carry out drug reviews and other
regulatory activities - from automatic government spending cuts
known as sequestration.
(Reporting by Toni Clarke in Washington; Editing by Bernard Orr)
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