Some questions and answers on prescription drug advertising

FDA Consumer, July-August, 2004 by Amie C. Braman

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) regulates prescription drug advertising. When we meet people outside the office, we are often asked the same questions. Here are answers to the most common questions we hear:

Q. Ten years ago, there were no TV ads for prescription drugs. Why are there so many now?

A. FDA regulations for prescription drug advertising have never prohibited advertising directly to consumers. Historically, doctors made most medical decisions, so pharmaceutical companies promoted only to health care providers. As time went on, however, patients became more empowered about their own role in maintaining their health. Pharmaceutical companies recognized this trend and started advertising directly to consumers in magazines and newspapers in the 1980s.

The regulations require that ads for prescription drugs that give information about the product's benefits must also give information about the product's risks. Print ads must provide all risks, whereas TV and radio ads must either list all risks or identify the major risks and give ways to provide additional information. For many years, companies struggled with how to accomplish this in a TV ad. In 1997, the FDA presented draft guidance describing one way companies could satisfy this requirement for prescription drug ads on TV. This guidance is why prescription drug ads provide ways to obtain more information in addition to the risk information contained in the TV ad itself, such as a Web site, a toll-free telephone number, encouragement to visit a doctor, or direction to a magazine ad with full risk information provided. Despite the sometimes-common misconception that the FDA relaxed the rules, in fact the guidance was simply a clarification of how companies could fulfill the requirement of the existing laws.

Q. Who approves these ads?

A. Companies must submit their ads to DDMAC at the time they first show them on TV or print them in magazines or newspapers. In most instances, we have no authority to pre-approve ads before they go on the air.

Companies have the option to submit proposed ads to us ahead of time. We are happy to provide comments before the ads are shown to the public.

Q. Are only the safest drugs allowed to be advertised on TV?

A. You may have noticed an announcer listing side effects in many TV ads--events such as headache, nausea, seizures, even fatalities. The regulations do not restrict advertising to only the safest drugs. This means that companies can advertise any approved prescription drug, no matter how serious the risks, as long as they present these risks in compliance with FDA rules. When the FDA approves a drug, it takes into account the benefits of the drug in relation to its risks.

All prescription drugs have some risks, and advertised drugs are no exception. Before you take a prescription drug, it is important for you to talk with your health care provider about whether the benefits of any drug outweigh its possible risks in your particular case.

Q. There are some drugs I don't want to see advertised. Why are they allowed on TV?

A. The regulations do not prohibit advertising of particular types of drugs. Therefore, prescription drugs for potentially embarrassing or private conditions such as acne, foot fungus, herpes, and erectile dysfunction can be advertised. Regardless of the type of drug or condition it treats, however, an advertisement that presents the benefits of a drug must include the risks associated with that drug. Sometimes these risks refer to personal topics, but they are still important to discuss with your health care provider. It is up to the sponsor and the network or cable TV station to determine when these ads air. The FDA does not have authority over such decisions.

Amie C. Braman, Ph.D., is a social science analyst in the FDA's Division of Drug Marketing, Advertising, and Communications.