Direct-to-Consumer Marketing of Medications

Concerns and Complaints

CHADD and the National Resource Center on AD/HD share the legitimate concerns of parents and other consumers about the accuracy of ads that describe the benefits of particular medications.  These concerns are especially heightened when the medications in question are used to treat disorders affecting children, including AD/HD.

The Food and Drug Administration (FDA) provides detailed regulations and guidance for advertising efforts aimed directly at consumers. Pharmaceutical companies are required to follow these directives when preparing such direct-to-consumer ad campaigns. In general, such ads must include information about the medication's side effects, contraindications (situations in which it should not be taken), and its effectiveness. Companies are required to submit their direct-to-consumer advertising materials to the Division of Drug Marketing, Advertising, and Communications (DDMAC) at the FDA's Center for Drug Evaluation and Research (CDER). Further information on the FDA's role in direct-to-consumer advertising can be found at the FDA's Keeping Watch over Direct-to-Consumer Ads Web page.

DDMAC does not provide approval for each and every advertising effort. Sometimes, companies will submit materials to the FDA before they implement certain marketing campaigns. This gives the FDA the opportunity to offer helpful feedback and suggestions; however, this practice is voluntary and not required.

For further information about the DDMAC and the regulations governing direct-to-consumer advertising, visit their home page at www.fda.gov/cder/ddmac.

Concerns and Complaints about Particular Advertising Efforts

Consumers who have questions or concerns about a particular commercial or other advertising effort should contact:

1. The manufacturer of the particular medication that is advertised; and
2. CDC Division of Drug Marketing, Advertising, and Communication (DDMAC) at 301-827-2828.

FDA 101 provides Information on using the FDA's Consumer Complaint System.