Opening Pandora's pillbox: using modern information tools to improve drug safety.
How the Food and Drug Administration (FDA) responds to criticism of its drug safety process will determine whether drug safety actually improves. Propping up the Office of Drug Safety with more bureaucratic prominence or adding new requirements to the preapproval process will add to the cost of drug development and not make drugs safer. New information tools can dramatically improve postmarketing surveillance and collection of data on safety. This information could then be used to reach more definitive regulatory conclusions sooner. New incentives will be needed to entice payers and product developers to work on building a broader, more robust system for collecting data on drug safety.
Gottlieb
Scott
S
American Enterprise Institute in Washington, DC, USA. Scott.Gottlieb@mssm.edu
D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D014487:Centers for Medicare and Medicaid Services, U.S.; D003625:Data Collection / Q000379:methods; D017277:Drug Approval / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D020407:Internet; D006278:Medicare; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards; D012107:Research Design; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*