FDA Announces “Bad Ad Program”

May 13, 2010

The FDA announced yesterday a new program called the “Bad Ad Program” designed to help health care providers detect and report misleading drug advertisements.  When I read about the new program it immediately brought to mind the various antihistamine advertisements touting how a particular drug works against outdoor and indoor allergens.  The ads basically imply, without specifically saying, that one antihistamine works for all types of allergies whereas another might only work for indoor allergies and another for only outdoor allergies.  I have had many patients ask me if a particular drug that seemed to be working for pollen allergy would also work for indoor allergies such as cat or dust mite allergy. 

The bottom line is histamine is a mediator that is responsible for many of the symptoms of allergies.  If a person is allergic to an allergen and has allergen antibodies (IgE antibodies) circulating in their system directed against a particular allergen, histamine is released by cells in response to the allergen.  Antihistamine medications act against this histamine release regardless of the allergen that is causing the problem.   Antihistamines work for histamine release caused by a food allergy, medication allergy, pollen allergy, dust mite allergy or pet allergy. 

It is completely misleading for a pharmaceutical company to create an ad highlighting the fact that their antihistamine works against indoor and outdoor allergens, since all antihistamines work against indoor and outdoor allergens.  Now, you may ask, how is it that one company can include this in their ad and another can not.  Well, that is actually the FDA’s fault.  The FDA approves each medication for a specific indication.  If the drug company does efficacy studies on an antihistamine using outdoor and indoor allergens, the FDA will approve the medication for both.  If the drug company’s efficacy study for a particular antihistamine only involves pollen, the FDA approves the drug specifically as only being indicated for seasonal pollen allergies (or outdoor allergies) and not indoor allergies.  This does not mean the medication does not work for indoor allergies, and the FDA should know that.  The problem is, drug companies are only allowed to include in their ads information pertaining to the specific FDA approved indication of the medication.   

Note: The content of this blog is for informational purposes only and is not meant as specific medical advice for a specific person.   If you have a medical problem, please contact your doctor.

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One Response to “FDA Announces “Bad Ad Program””

  1. Sharon Bar-Lev Says:

    Very informative and kinda pisses me off that the FDA can work in this fashion. I thought this was an organization that was created to benefit/inform those TAKING the drugs.
    Your explanation is SO logical and it amazes me that people can be so misled by advertising. Sometimes people need to just sit back and think logically for a minute.


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