Health care economic information that is disseminated to formulary committees must be based on “competent and reliable scientific evidence.” Yet FDA has traditionally applied a more restrictive “substantial evidence” standard in its enforcement approach, said panelists at a recent conference, who questioned whether the growing government involvement in funding comparative effectiveness research would change this approach.
The government’s growing role in sponsoring research on comparative effectiveness of pharmaceutical treatments is triggering questions about how the resulting data and analytical methods will be viewed by FDA in its regulation of companies’ dissemination of such information.
Under the current statutory standard, health care economic information that is disseminated to formulary committees and similar entities must be...