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Beyond post-marketing research and MedWatch: Long-term studies of drug risks

Authors Resnik D

Published 4 October 2007 Volume 2007:1 Pages 1—5


David B Resnik

National Institute of Environmental Health Sciences (NIEHS)/National Institutes of Health (NIH)

Abstract: Critics of the drug safety system have discussed many different potential reforms, ranging from mandatory registration of clinical trials to increasing the power of regulatory agencies, but few have discussed one of the most important ways of enhancing safety: increasing the number of long-term studies of medications. Long-term studies of the risks and benefits of drugs can provide useful information for regulators, healthcare professionals, and patients. Government funding agencies should lead the effort to conduct long-term studies of drugs, but private companies should also be required to lend financial support. Because cost-effectiveness is likely to be an important consideration in conducting this research, funding agencies should focus, at first, on drugs that are used to treat common, chronic conditions.

Keywords: drug safety, FDA, post-marketing studies, MedWatch, long-term studies

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