95.023 Direct-to-Consumer

95.023

Direct-to-Consumer Advertising of Prescription Drugs and Implantable Devices: The Texas Medical Association advocates that direct-to-consumer (DTC) prescription drug and medical device advertisements should contain the disclaimer, “Your physician may recommend other appropriate treatments.”  TMA strongly supports AMA Policy H-105.988, which clearly disapproves of misleading advertising for prescription drugs to the general public and supports research into the effects of DTC marketing, including physician and patient behavior and the impact of DTC ads on the cost of medical services.  TMA further opposes product-specific DTC advertisements and supports a ban on DTC advertising for prescription drugs and implantable medical devices, and until such a ban is in place, opposes product-claim DTC advertising that does not satisfy the following AMA guidelines:

(a) The advertisement should be indication-specific and enhance consumer education about the drug or implantable medical device and the disease,     disorder, or condition for which the drug or device is used. 

(b) In addition to creating awareness about a drug or implantable medical device for the treatment or prevention of a disease, disorder, or condition, the advertisement should convey a clear, accurate, and responsible health education message by providing objective information about the benefits and risks of the drug or implantable medical device for a given indication. Information about benefits should reflect the true efficacy of the drug or implantable medical device as determined by clinical trials that resulted in the drug’s or device’s approval for marketing. 

(c) The advertisement should clearly indicate that the product is a prescription drug or implantable medical device to distinguish such advertising from other advertising for non-prescription products. 

(d) The advertisement should not encourage self-diagnosis and self-treatment, but should refer patients to their physicians for more information. A statement, such as "Your physician may recommend other appropriate treatments," is recommended.

(e) The advertisement should exhibit fair balance between benefit and risk information when discussing the use of the drug or implantable medical device product for the disease, disorder, or condition. The amount of time or space devoted to benefit and risk information, as well as its cognitive accessibility, should be comparable. 

(f) The advertisement should present information about warnings, precautions, and potential adverse reactions associated with the drug or implantable medical device product in a manner (e.g., at a reading grade level) such that it will be understood by a majority of consumers, without distraction of content, and will help facilitate communication between physician and patient. 

(g) The advertisement should not make comparative claims for the product versus other prescription drug or implantable medical device products; however, the advertisement should include information about the availability of alternative non-drug or non-operative management options, such as diet and lifestyle changes, where appropriate, for the disease, disorder, or condition. 

(h) In general, product-specific DTC advertisements should not use an actor to portray a health care professional who promotes the drug or implantable medical device product, because this portrayal may be misleading and deceptive. If actors portray health care professionals in DTC advertisements, a disclaimer should be prominently displayed. 

(i) The use of actual health care professionals, either practicing or retired, in DTC to endorse a specific drug or implantable medical device product is discouraged but, if utilized, the advertisement must include a clearly visible disclaimer that the health care professional is compensated for the endorsement. 

(j) The advertisement should be targeted for placement in print, broadcast, or other electronic media so as to avoid audiences that are not age appropriate for the messages involved. 

(k) In addition to the above, the advertisement must comply with all other applicable Food and Drug Administration (FDA) regulations, policies, and guidelines. (CSA Rep. 2-I-01; substituted CSA Rep. 3-A-09; amended CSPH Rep. 5-A-19).

Last Updated On

June 11, 2019