FDA has been rolling out new guidelines for using interactive media in recent months. The new guidances clarify some murky areas, but may not make online communications any easier.
FDA’s Office of Prescription Drug Promotion (OPDP) provides some useful advice in its new advisories, which were discussed further in an OPDP webinar July 10. Overall, the agency sticks to its rules requiring ads and promotional messages to be accurate, not misleading, balanced, and limited to approved uses. Because it’s very hard to get full risk information into a 140-character tweet or search engine listing, such communiqués may not fit FDA’s regulatory scheme for drugs and medical products, according to a draft guidance on using the Internet and social media platforms with character space limitations. There’s no leeway to use icons to indicate that all drugs are risky, as proposed by industry; without equal presentation of risks and benefits in a character-limited message, OPDP advises marketers to “reconsider using that platform,” especially for products with complex indications or serious risks.
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