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 era of big pharma off-label promotion cases may be coming to a close, but federal prosecutors are eyeing other industry practices for enforcement, including unsupported promotional claims of economic superiority and superior efficacy, and manipulation of the average sales price system.

Pfizer's $2.3 billion settlement with the U.S. Department of Justice is unprecedented in size and scope, resolving allegations of off-label marketing of four drugs and kickbacks to health care providers involving nine other drugs. Moreover, the deal includes the largest criminal fine ever imposed by the U.S. government in any matter