“It should be called the Big Pharma Cash Bonanza Act. The system of drug approval we already have is bad enough but this would only make things worse.” Admin
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.
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