Key Elements in Adverse Drug Reactions Safety Signals: Application of Legal Strategies.

Abstract

Adverse drug reactions, or unintended and harmful outcomes related to the administration of a pharmaceutical product, are a major public health concern, particularly for cancer patients. If counted as a separate cause of death, adverse drug reactions would represent the fourth leading cause of death in the United States. Several legal strategies are available to help mitigate their occurrences and to compensate victims for the harm that results from adverse events. Prior to FDA approval of a drug, the limited size and duration of clinical trials often fail to detect adverse drug reactions. However, after FDA approval, pharmacovigilance efforts are bolstered by recent expansions of FDA post-marketing regulatory powers codified in the 2007 Food and Drug Administration Amendments Act, as well as advances in big data analytics that improve adverse signal detection through data mining of large electronic health records. For victims of adverse drug reactions, tort lawsuits filed in the courts help compensate for the harm suffered and may also serve as warnings to manufacturers to improve drug safety to avoid future legal liability. While encouraging developments have occurred, new and existing legal structures to mitigate and compensate for adverse drug reactions must continue to be refined given increasingly complex pharmaceutical agents.