FDA Issues Proposed Ad Guidelines For Drugs, Medical Devices

The Food and Drug Administration Tuesday issued proposed advertising guidelines for drug and medical device makers with suggestions about how to properly present risk information in promotional material aimed at consumers and health-care professionals.

The draft guidelines, posted on the agency's Web site Tuesday, aren't binding, but they contain several suggestions to industry on how to avoid running afoul of agency rules. The FDA said the mission or minimization of risk information is the most frequent violation of the regulations cited in dozens of enforcement or warning letters sent to sponsors each year.

The agency said, "the public health is best served when risk and effectiveness information about drug and device products is clearly and accurately communicated."

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

The FDA said it looks at the "net impression" of a consumer advertisement or material given to doctors to determine if a piece conveys accurate information about a particular product.

The FDA said promotional material can be misleading even if specific individual claims or presentations aren't misleading. As an example, the FDA said an advertisement for a cholesterol-lowering drug that uses audio to lay out the drug's side effects could be considered misleading if it contains upbeat music and "discordant" images of patients benefiting from the medicine while the risk information is detailed.

The 24-page guidance document goes into detail about how fonts, the type of contrast and white space used in print materials can be used to best present risk information.

The guidelines suggest a product that requires monthly blood tests to check for liver damage should state that in clear language rather than using statements that state there's a need for "certain monitoring."

The agency will be accepting comments on the draft guidance document for 90 days before it issues final guidelines. The draft guidance document is set for publication in Wednesday's Federal Register.

Source: Nasdaq