Browsing by Subject "FDA"

Now showing 1 - 3 of 3
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    Do Faster FDA Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act
    (2008) Grabowski, Henry G; Wang, Richard
    times have significantly declined since the passage of PDUFA in 1992, while agency resources have expanded through user fees. After the recent withdrawal of Vioxx and other high-profile products, there have been increasing concerns that PDUFA has adversely affected drug safety. Combining several comprehensive databases, we analyze how FDA review time, drug novelty, and U.S. launch lag affect the occurrence of serious adverse events 1992-2002 U.S. new drug introductions. We find that more novel drugs and those with shorter U.S. launch lags have a larger number of serious events. After controlling for these and other factors, there is no association between FDA review time and adverse events. Many novel products, with significant anticipated benefits and risks, have black box warnings at the time of product launch. We find that black box warnings (except for pregnancy ones) are associated with more serious events. Notably, many serious adverse events involve rare occurrences that are not observable in pre-market clinical trials. Policymakers should consider our findings in future PDUFA changes, including dedicating a portion of user fees to post-marketing surveillance.
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    Lost in Translation: The Gap in Scientific Advancements and Clinical Application.
    (Frontiers in bioengineering and biotechnology, 2016-01) Fernandez-Moure, Joseph S
    The evolution of medicine and medical technology hinges on the successful translation of basic science research from the bench to clinical implementation at the bedside. Out of the increasing need to facilitate the transfer of scientific knowledge to patients, translational research has emerged. Significant leaps in improving global health, such as antibiotics, vaccinations, and cancer therapies, have all seen successes under this paradigm, yet today, it has become increasingly difficult to realize this ideal scenario. As hospital revenue demand increases, and financial support declines, clinician-protected research time has been limited. Researchers, likewise, have been forced to abandon time- and resource-consuming translational research to focus on publication-generating work to maintain funding and professional advancement. Compared to the surge in scientific innovation and new fields of science, realization of transformational scientific findings in device development and materials sciences has significantly lagged behind. Herein, we describe: how the current scientific paradigm struggles in the new health-care landscape; the obstacles met by translational researchers; and solutions, both public and private, to overcoming those obstacles. We must rethink the old dogma of academia and reinvent the traditional pathways of research in order to truly impact the health-care arena and ultimately those that matter most: the patient.
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    You Can Trust the FDA’s Vaccine Process
    (Wall Street journal (Eastern ed.), 2020-09-20) McClellan, Mark; Gottlieb, Scott