U.S. Senators Michael Bennet (D-Colo.), Orrin Hatch (R-Utah) and Richard Burr (R-N.C.) introduced a bipartisan bill intended to aid rapid approval of breakthrough drugs and treatments for patients who need them more quickly.
The Advancing Breakthrough Therapies for Patients Act would expedite U.S. Food and Drug Administration approval and provide more flexibility when a drug or treatment shows dramatic responses early in development, while still ensuring drug safety and efficacy. For patients, this proposal would allow FDA the ability to move towards more innovative clinical trials, such as minimizing the number of patients enrolled in trials and shortening the duration of trials, when scientifically appropriate.
"Our bill provides the flexibility in approval mechanisms so home-run treatments that show great promise early on reach patients more quickly," said Sen. Bennet. "It also strikes a careful balance between providing regulatory certainty for developers of these breakthrough treatments and maintaining the level of drug safety and efficacy patients expect and deserve."
Several groups have thrown their support to the proposed legislation, including Friends of Cancer Research and the National Venture Capital Association.
The Advancing Breakthrough Therapies for Patients Act would expedite U.S. Food and Drug Administration approval and provide more flexibility when a drug or treatment shows dramatic responses early in development, while still ensuring drug safety and efficacy. For patients, this proposal would allow FDA the ability to move towards more innovative clinical trials, such as minimizing the number of patients enrolled in trials and shortening the duration of trials, when scientifically appropriate.
"Our bill provides the flexibility in approval mechanisms so home-run treatments that show great promise early on reach patients more quickly," said Sen. Bennet. "It also strikes a careful balance between providing regulatory certainty for developers of these breakthrough treatments and maintaining the level of drug safety and efficacy patients expect and deserve."
Several groups have thrown their support to the proposed legislation, including Friends of Cancer Research and the National Venture Capital Association.
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