For those who haven’t read it, Ed Silverman over at Pharmalot has a great interview with former FDA associate chief counsel and former Pfizer senior counsel Arnie Friede, about the new “BadAd” program that FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) rolled out yesterday. The program gives doctors and health care providers a way to report misleading or illegal drug promotion to the agency, which has not, until now, had a mechanism for reviewing promotion that happens in the doctor’s office, off the page or TV screen.
When Silverman asked how an already resource-strapped FDA would follow up on every report, here’s what Friede said:
On balance, the FDA probably feels there’s a lot of violative behavior they simply can not monitor with limited resources. To some extent, yes, many of these reports may reflect a doctor’s misunderstanding of what was actually said. That’s certainly a possibility and, hopefully, the FDA willl find a reasonable way to separate the wheat from the chaffe. But if the objective is compliance and not enforcement, then this is an additional incentive for a company to closely monitor and control communications by their sales people. For an enforcement agency, I think it’s an understandable, perhaps even brilliant move…Read the whole thing here.
-Kate Petersen, PostScript blogger