And it’s about time. The Food & Drug Administration in the U.S. is looking for tattle-tales who are fed up with aggressive prescription drug advertising and promotion practices that skate around the truth. For the sake of clarity, let’s call this “lying”. The FDA’s new and long overdue ‘Bad Ad Program’ is asking health care professionals to recognize and report sleazy tactics in:
Big Pharma TV, radio and print advertising
all presentations by pharmaceutical sales reps
all presentations by physicians who are being paid by Big Pharma
all written or printed prescription drug promotional materials
Here are three examples of the ‘bad ads’ that concerned health care professionals are now being asked to look out for:
1. You attend a presentation given by a physician funded by the manufacturers of Drug X, which features a slide show presenting benefits about Drug X, but no risk information.
This presentation would be misleading because it fails to include a fair balance of benefit and risk info for Drug X.
2. You visit the commercial exhibit hall during a medical conference, and a drug company representative there tells you that Drug X is effective for a use that is not on the FDA-approved product labelling.
This presentation would be illegal because it promotes an off-label use for which it has not been approved.
3. A drug rep visiting your office during a routine ‘detail’ call tells you: “Doctor Smith, our company’s Drug X delivers rapid results in as little as three days.”
This presentation is misleading because it overstates the effectiveness of the drug. The majority of patients studied in the clinical trials for Drug X showed results at 12 weeks, with only very few showing results in three days.
The plan for the program came from two former drug company pitchmen who joined the FDA as ad watchdogs, according to Reuters. Mike Sauers, who conceived of the idea with Bob Dean, said the goal is to teach doctors “how to be better consumers of information they receive from the drug reps” – a skill they don’t typically learn in medical school.
The FDA news release adds:
“The Bad Ad Program will help health care providers recognize misleading prescription drug promotion, and provide them with an easy way to report this activity to the agency.”
Reports can be made anonymously. Bad ads include one or more of the following fraudulent claims:
- omitting or downplaying of risk
- overstating the effectiveness
- promoting off-label or unapproved uses
- misleading drug comparisons
Arguably, the FDA is in the regulatory business, not the monitoring and policing business.
When Big Pharma stretches the truth about its drugs - as it likes to do when billion dollar sales are at stake – the FDA can’t keep up. Monitoring prescription drug promotion until now has relied primarily on reviewing suspect pieces submitted to the agency by industry complaints or field surveillance at large medical conferences. So the FDA has had limited ability to monitor promotional activities that occur in private – like in doctors’ offices or at by-invitation only meetings to convince docs to prescribe their specific drugs.
Health care professionals who are concerned about Big Pharma’s misleading promotional tactics will essentially be partnering with the FDA in the crackdown on these fraudulent practices.
Back in Big Pharma Land, of course, this announcement has rattled a few cages. Quelle surprise . . .
Peter Pitts (who wears the uber-CorporateSpeak title of ‘Global Head of Regulatory & Public Policy’ at Omnicom Group’s Porter Noveli) explained in an Advertising Age interview:
“‘Bad Ad’ is a bad program because it deputizes people who don’t understand the law. That means many bad things, not the least of which is vigilantism, with doctors who might not like Direct-To-Consumer drug ads who go on personal jihads on ads they don’t like - ads that very well might be in perfect compliance.”
The Bad Ad Program is administered by the FDA’s Division of Drug Marketing, Advertising, and Communications in the Center for Drug Evaluation and Research.
Find out more about this program from the FDA.