Healthy Skepticism Library item: 17797
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Electronic Source
Silverman E
FDA's BadAd Program Is Brilliant: Friede Explains
Pharmalot 2010 May 12
http://www.pharmalot.com/2010/05/the-fdas-badad-program-is-brilliant-friede-explains/
Full text:
Yesterday, the FDA launched what it calls a new educational outreach effort to encourage doctors and other healthcare providers to report misleading prescription drug promotion and provide them with an easy way to report this activity to the agency’s DDMAC, the Division of Drug Marketing, Advertising, and Communications, which issues warning letters for violations. The hope for the BadAd program is that drugmakers will toe the line and curtail promotional efforts that go too far. We spoke with Arnie Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer, about the program…
Pharmalot: Do you think the program is warranted?
Friede: From the FDA’s prepecrtive, we are see an ongoing and even increasing amount of correspondence from DDMAC, and I think they perceive the messsage they’ve been sending all along is not reaching everyone and continues to be a problem in the kinds of promotional communication being seen. And I think they’ve probably concluded that if there are problems in written materials, there are likely to be greater problems in face-to-face communications that are largely unscripted.
Pharmalot: Okay, but will it work? Many doctors may be annoyed about DTC ads or the number of reps who stop by their offices, but that doesn’t necessarily mean the FDA will get lots of reports.
Friede: Look at it this way. If I’m a sales rep, I can never be 100 percent sure the doctor I’m talking to is just a dispassionate listener. Many docs are annoyed at promotional practices of pharma companes. I do think many doctors, or some doctors, would not hesitate to blow the whistle if they felt something was particularly wrong. There’s not a great deal of love out there for sales reps to begin with. Samples seem to be the way to get access. Reps aren’t seen for altruistic reasons. So I do think there are some docs who will report under this program as there are some who already do so. And to leverage these resources could be of enormous help in putting reps on their toes.
Pharmalot: Sure, but isn’t it possible some docs will simply misconstrue some conversations? And if the FDA is short on resources now, how are they going to chase down every report?
Friede: 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 from their perspective
Pharmalot: Might this not swing the pendulum in the other direction and impede the flow of information that is genuinely needed?
Friede: Those interactions between reps and doctors are valuable, and the FDA has said so, notably in respect to REMS requirements, where important safety information is to be communicated. So you might be throwing another impediment to making those interactions meaningful and putting the doctor in the role of quasi-policeman. This might be a deterrent to having open and candid conversations, the reps may feel they are impeded from going beyond anything their scrips provide. It could effect the value of that interaction, so to the extent it impedes that dialgoue, then I suppose there is a downside.
And you don’t want to encourage false reporting or distorted perceptions. But it’s not necessarily about the enforcement. It’s not about the actual reports that come in, although I suppose that it would be good to ding a few people once in awhile. The deterrent value in encouraging additonal compliance may be the predominant rationale. It doesn’t have to succeed in generating massive amounts of reports. It only has to communicate to industry there may be massive amounts of reporting. I’m certain that Tom Abrams (who heads the FDA’s DDMAC) had to sell this at the highest levels. He doesn’t have unilateral authority to initiate something of this sort himself. This obviously was well thought through.
