2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC299
Submitter : Mr. James Doering Date & Time: 12/09/2005 10:12:28
Organization : Mr. James Doering
Category : Individual Consumer
Issue Areas/Comments
Those companies that wish to advertise prescription drugs on radio and television should be required to agree to stringent "truth in advertising" regulations and be subject to severe and substantial penalties (civil and criminal) for false and/or unsubstantiated statements in their ads or for failure to reveal adverse side effects.

We have already seen certain prescription drugs advertised on television, for example, that were later found to be so dangerous that they were either pulled from the market or required to display "black box" warning labels. Such behavior should result in severe penalties for the manufacturer, including being banned from advertising for a period of years.

You are considering rules and regulations that affect the health and well being of hundreds of millions of Americans. You have as great a legal obligation to protect these people from unethical and unscrupulous advertisments for prescription drugs as you do to protect them from the importation of substandard or contaminated prescription drugs. Selling prescription drugs should be held to higher standards than promoting the sales of automobiles or washing machines.