FDA Sets Up New Campaign for HealthCare Providers to “Rat” on Big Pharma – Reporting Bad Marketing and Advertising Practices

The campaign allows individuals to be anonymous too, and with recent ads on the web and TV this has become a focus. The FDA not only enforces this in the drug and device area but also looks at how foods and other items are marketed and associated advertising from the consumer side of the agency which is in a different area of enforcement.

Some of the commercials on TV that make me crazy are the ones about the anti-depression drugs. If I had my way I would ban most of those that I see as they are “suggestive” in my opinion and further enhance the idea that you may be depressed and don’t know it, or it could lead to feelings of depression, but those are my own thoughts.

Educational material will be available to create and give some guidelines as to what may be considered not appropriate. This is actually not a bad idea at all as perhaps the outcome will end up changing some of the marketing we see today and perhaps it will move to a more educative format rather than being projected as “suggestive”.

From the website:

“1. Can I report anonymously?

Yes, anonymous complaints often alert FDA to potential problems. However, complaints accompanied by names and contact information are helpful in cases for which FDA needs to follow-up for more information.

2. Will DDMAC be able to stop the misleading promotion?

In many cases, yes, especially if evidence is provided. Evidence can include the actual promotional materials or documentation of oral statements made by company representatives.

3. What will happen to my complaint once I have contacted DDMAC?

The information you provide will be sent to the Regulatory Review Officer in DDMAC responsible for this class of drugs. The reviewer will evaluate it and determine if it may serve as the basis for a potential enforcement action or as valuable information for our ongoing surveillance activities.

4. How do I learn more?

To learn more about DDMAC in-service training for large medical group/hospitals or to speak directly with a DDMAC Reviewer, call 301-796-1200.”

You can email or make a phone call. Additional information is available at the FDA Website that has been set up with some information and guidelines and they will email updates to you if you subscribe as well. BD

The FDA is asking healthcare professionals to keep an eye out for violative promotion and to call 1-877-RX-DDMAC or emailing badad@fda.com when they see it.
"Recognize and report" is the message of the agency's Bad Ad Program, an educational outreach effort by the Division of Drug Marketing, Advertising and Communications (DDMAC) that will “help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” according to DDMAC director Tom Abrams.

The program will be rolled out in three phases, said FDA. In Phase 1, DDMAC will engage healthcare providers and distribute educational materials at select medical conventions and through partnerships with medical societies. Phases 2 and 3 “will expand the FDA's collaborative efforts and update the educational materials developed for Phase 1,” said FDA.

Drugmakers spend about $20 billion per year to promote their products in various mediums, ranging from medical journal ads and information booths at conferences to multimillion dollar TV campaigns.

How's my detailing? Dial 1-877-RX-DDMAC - Medical Marketing and Media