The Senate on Wednesday approved the 21st Century Cures Act, which aims to boost funding for medical research, enhance mental healthcare research, provide more money to fight the national opioid epidemic and significantly change the regulation of drugs and medical devices.
The bill outlines quicker, more pro-industry processes for the Food and Drug Administration to approve new drugs and devices, reports The Wall Street Journal.
Here are four ways the legislation could change the regulation process.
1. The bill would allow the FDA to rely more widely on shorter, simpler trials when reviewing drugs for approval. New antibiotics could undergo shorter trials and an abundance of other drugs could receive expanded approvals for new treatment uses based on lower amounts of evidence, according to WSJ.
2. The act would also allow the agency to more heavily rely on "surrogate endpoints" — outcomes based on measuring things like biomarkers in blood or changes to a tumor — when reviewing clinical trials, as opposed to outcomes like death rate that are harder to prove and measure, according to the report.
3. When reviewing medical devices, the bill would allow the FDA to use smaller studies, less scientifically rigorous research and real-world evidence. Examples of real world evidence include data from company registries of patients and other information that does not meet the current gold-standard: clinical trials where patients are randomly assigned a study drug, placebo or conventional treatment, reports WSJ.
4. Devicemakers would also benefit from a measure requiring the FDA to more quickly approve breakthrough products offering significant improvements over existing devices through the agency's priority review program.
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