2004D-0042 - Draft Guidances for Industry on Making Direct-to-Consumer Advertising More User Friendly; Availability
FDA Comment Number : EC2
Submitter : Ms. Michele Okamoto Date & Time: 04/13/2004 12:04:34
Organization : Slippery Rock University
Health Professional
Category :
Issue Areas/Comments
Direct advertising of medications influences consumers to perceive a product as a desirable commodity. Ads are often framed as vague questions that may apply to large numbers of people at any given time. This creates a demand that fills the goal of increased numbers of prescription for a product. Studies show that physicians do, indeed, prescribe more of these drugs when requested by patients.

Many patients are already on one or more medications, including over-the-counter preparations. Polypharmacy (multiple medications) has been associated with adverse drug events, which include interactions and side effects. Some of these may be serious or fatal.

The US population is aging. Older adults, the largest consumers of medications, are therefore at increased risk for adverse drug events related to polypharmacy. They often must bear the most or all of the financial costs as well. They may be seriously vulnerable to direct consumer advertising that glosses over risks.

When product risk information is presented, it frequently seems to be an afterthought: after the desire for the medication has been created! It is often printed in small type and/or rapidly listed almost verbatim from the approved package insert, as if merely fulfilling some obscure government rule.

The reality is that medication decisions involve risks and benefits that are not easily separated. With every additional medication, the risk to these older adult consumers increases. There should be as much prominence in direct consumer advertising given to primary side effects, costs and potential devastating consequences as there is to potential benefits. Also, the subject of polypharmacy risk should be included.