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If passed in the Senate and signed by President Obama, the “21stCentury Cures Act” would foster significant regulatory changes in the introduction of new drugs to the market. The legislation passed 344-77 with strong, bipartisan support, though opponents raise concerns about the Act’s lack of assurances of patient safety. The purpose of this legislation is to reduce the bottlenecks in the regulatory process that allow the development of new drugs. The Act would trim regulations by allowing for shorter clinical studies involving fewer individuals for certain kinds of drugs. It would also allow for expanded use of surrogate endpoints as evidence of the efficacy of drugs. Surrogate endpoints are biomarkers which are thought to predict clinical benefit, but are not outright measures of such benefit. Case studies, patient registries and existing health care data can also be utilized to speed up clinical trial endpoints. Opponents of the Act have expressed concerns that these reforms will compromise patient safety.
The fate of the bill currently rests with the Senate.