Work

Risk, Responsibility, and Generic Drugs

Year: 2012

Type: article

Abstract: A Supreme Court ruling that generic-drug manufacturers can't be held liable for not updating their labels with new warnings leaves gaps in responsibility over late-arising safety issues. A central repository of data on adverse drug events could help address the problem.

Source: New England Journal of Medicine

DOI: 10.1056/nejmp1208781

Authors: Aaron S. Kesselheim, Jerry Avorn, Jeremy A. Greene

Institutions: Brigham and Women's Hospital, Harvard University

Language: English

Topic: Pharmacovigilance and Adverse Drug Reactions

Subfield: Toxicology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

Open Access status: bronze

Funders: Agency for Healthcare Research and Quality, U.S. National Library of Medicine

Awards: OFF-LABEL PRESCRIBING: COMPARATIVE EVIDENCE, REGULATION, AND UTILIZATION, When is a Medicine Good Enough? The Problem of Therapeutic Equivalence, 1959-2009