Work

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

Year: 2007

Type: article

Abstract: Beyond post-marketing research and MedWatch: Long-term studies of drug risks David B ResnikNational Institute of EnvironmentalHealth 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

Source: Drug Design Development and Therapy

DOI: 10.2147/dddt.s2352

Author: David Resnik

Institutions: National Institutes of Health, National Institute of Environmental Health Sciences

Language: English

Topic: Pharmacovigilance and Adverse Drug Reactions

Subfield: Toxicology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,836