FDA proposal addresses cognition and context in drug, medical device promotions.

Merely citing the specific risks of a drug or medical device may not be enough to satisfy the Food and Drug Administration’s watchdogs. Advertisers may have to tone down the happy imagery and take care with their typography, too.

In proposed advertising guidelines for drug and medical-device makers, the FDA would consider “the net impression conveyed by all the elements of a piece” The draft guidelines, posted May 26 on the agency's Web site, suggests ways to present risk information to consumers and health-care professionals.

Prescription drug ads often show healthy looking patients while explaining benefits and then rush through or provide distractions when required risk information is conveyed, Reuters reported.

Example: A Schering-Plough Corp. ad for allergy drug Nasonex drew criticism at a 2008 Congressional hearing. In the ad, a bee flew around during a description of side effects, but hovered while benefits were explained.

Proposal Is Preventive Medicine

The proposed guidelines wouldn’t be binding but would offer ways the industry could avoid running afoul of FDA rules, the Wall Street Journal reported. The FDA said the omission or minimization of risk information is the most frequent violation cited in dozens of enforcement or warning letters each year.

For instance, the guidelines suggest a product that requires monthly blood tests to check for liver damage should state that in clear language, rather than the vague phrase, “certain monitoring.”

The proposal said promotional material can be misleading even if specific claims aren’t. A television advertisement for a drug could be considered misleading if it contains upbeat music and images of patients benefiting from the medicine while the risk information is detailed.

“Manufacturers should focus not just on individual claims or presentations but on the messages conveyed by the promotional piece as a whole,” the proposal said.

The 24-page document even discusses typography and layout, the type of contrast and even white space in print materials that can best present risk information.

While drug and medical-device trade groups have advertising guidelines, the industry has asked the FDA for advice on how to comply with agency rules, which require that information about effectiveness and risk be presented in a balanced manner.