Beyond debacle and debate: developing solutions in drug safety.
In the 5 years since the Vioxx debacle, efforts have been made to enhance drug safety. These include the introduction of legislation that expands the power of drug regulatory agencies, new data transparency standards and increased requirements for funding of post-marketing drug surveillance. Nevertheless, some doubt remains that these changes will be sufficient to address the increasing challenges in the field of drug safety. Here, from the perspective of a drug researcher, I discuss key areas for further development that could deliver long-term solutions to these challenges: enhanced tools for the detection of safety signals, innovative phased drug launches, new risk stratification techniques and improved pharmacovigilance operations.
Ray
Amrit
A
Bristol-Myers Squibb Company, Research & Development, Princeton, New Jersey 08543-5400, USA. amrit.ray@bms.com
D000818:Animals; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000379:methods / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000639:trends