Making Research Data Available: An Ethical Imperative Demonstrated by the SSRI Debacle

Abstract

The last decade has seen enormous expansion in the use of psychotropic medications to treat behavioral and emotional disorders in children and adolescents. Because much prescription of these agents is off-label, serious attempts are being made to encourage pharmacological research in children. In 1979, the FDA began to encourage increased labeling for pediatric drug use with limited success. In 1997, FDAMA legislated 6 months of market exclusivity as an inducement for pharmaceutical manufacturers to provide pediatric information for labeling. In January 2002, the Best Pharmaceuticals for Children Act extended previous legislation and mandated studies of off-patent medications that do not have exclusive marketing rights by pharmaceutical manufacturers ( Best Pharmaceuticals for Children Act, 2002 Best Pharmaceuticals for Children Act, Public Law 107–109, 115 Stat. 1408 (2002) (codified as amended at 42 USCA § 284m (West 2003), 21 USCA § 355b (West Supp. 2003), 21 USCA § 393a (West Supp. 2003) Google Scholar ). On December 3, 2003, President Bush signed the Pediatric Research Equity Act into law. This law gives the FDA authority to mandate pediatric research on medications for which manufacturers hold patent or exclusivity rights. Consequently, we can expect more pediatric research on psychotropic medications in the future ( Pediatric Research Equity Act, 2003 Pediatric Research Equity Act (2003), Public Law 109–155, 117 Stat. 1936 (to be codified at 42 USC §§ 217–217a, 262, 284m, 21 USC §§ 355–355b & 393a) Google Scholar ).