Drug and medical device ads on TV shouldn't overstate drugs' benefits while downplaying their risks, the U.S. Food and Drug Administration said in a new draft guidance.
In issuing the guidelines, the FDA noted that the omission or minimization of risk information was the most common violation cited in enforcement or warning letters, the Wall Street Journal reported.
The proposed advertising guidelines offer several suggestions on how drug and medical device makers can avoid breaking FDA rules. For example, the agency said that a product that requires monthly blood tests to check for liver damage should clearly state that fact, instead of telling patients and health-care professionals there is a need for "certain monitoring." The FDA also advised companies against the use of distracting music and images and music that may affect consumers' ability to learn about potential side effects.
The draft guidelines were posted Tuesday on the FDA Web site. The agency is accepting comments for 90 days before issuing final guidelines, the Journal reported.