Uncle Sam (and the FDA) Wants You!

How you can help the FDA keep drug companies honest

(RxWiki News) The FDA is reaching out to healthcare professionals and others who may come across misleading medical advertising with their Bad Ad Program.

On December 3rd, the Food and Drug Administration sent their first warning letter on behalf of their new Bad Ad Program, which allows prescribers and healthcare professionals to report misleading drug labels and other concerns directly to the FDA. More importantly, the program is open to any person who wants to report misleading drug promotion -- although at the moment it is directed at medical professionals.

The Bad Ad Program's first official warning letter was sent to Derma-Smoothe/FS® and outlines in detail customer concerns listed on the company's website that were inaccurately dismissed using false information. Derma-Smoothe Body Oil is used as a skin ointment for children and infants, who are more sensitive to adverse reactions and side effects.

Designed by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC), the Bad Ad Program aims to widen the FDA's effectiveness by asking everyday people to report misleading information. The most common complaints about unethical advertising include the downplaying of a drug's health risks, suggesting off-label uses, comparisons to other drugs and exaggerations of its effectiveness. An online program called EthicAd will help consumers know how to spot bad ads.

The FDA kicked off the initiative in May 2010 with three phases in mind: Phase 1 included exhibition of the program to medical societies up until September 2010. Phases 2 and 3 involve further expansion and the improvement of educational materials.

People can send in complaints anonymously, however including contact information helps in cases that require follow-up and further investigation. Reports can be made by email at badad@fda.gov or by calling 877-RX-DDMAC.

To read the first Bad Ad Program warning letter, go here:

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Review Date: 
December 27, 2010