A U.S. House of Representatives committee on Thursday unanimously approved a bill to speed new drugs to the market, overcoming last-minute wrangling over how to pay for the legislation.
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.
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.