FDA Hopes to Keep Pharma Honest With “Bad Ad” Program

assorted-capsulesSending salespeople into doctors’ offices can be an effective way for pharmaceutical companies to get the latest treatments into the hands of patients. Drug companies spent three times more on promoting medications directly to doctors than they did on advertising in 2008, according to the Congressional Budget Office. However, complaints of fraudulent activity related to pharmaceutical salespeople has prompted the U.S. Food and Drug Administration to launch a new campaign taking aim at misleading drug promotions.

Last week, the FDA unveiled its “Bad Ad” program to encourage physicians to report questionable pharmaceutical sales pitches. The federal agency plans to send letters to 33,000 healthcare providers about the campaign, distribute educational materials, and set up booths at major medical conferences to speak with physicians. Promotional fraud includes bribing healthcare providers, not informing physicians of risks and side effects, or pushing unapproved uses for drugs (also known as off-label marketing). Although the FDA can monitor prescription drug promotion through advertisements, industry complaints, and field surveillance at medical conventions, it is considerably more difficult to monitor promotional activities that occur in private settings.

Clashes with the FDA over drug promotions are nothing new for pharma companies. A November article in Bloomberg detailed some of the disputes that companies such as Pfizer, Eli Lilly, and Bristol-Myers Squibb have had with the FDA over off-label marketing. In April, AstraZeneca settled with the federal government for $520 million in a dispute over the off-label use of the antipsychotic drug Seroquel.

One expert quoted in the Bloomberg article noted that many physicians don’t keep track of FDA-approved uses for drugs. Clinical decision support software such as SafeMed or ActiveHealth Management‘s CareEngine offer one option for keeping doctors up to date on the latest standards of care.

We’d like to hear your opinion on the FDA’s new program. How effective do you think the “Bad Ad” campaign will be at stopping promotional fraud?

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