Back to Journals » Drug Design, Development and Therapy » Volume 1

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

DOI https://doi.org/10.2147/DDDT.S2352



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

Creative Commons License © 2007 The Author(s). This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.