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Clock Starts Ticking on Issuance of FDA's Social Media Guidance

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By Alexander Gaffney

The end is near—for marketing professionals waiting for the US Food and Drug Administration (FDA) to issue its long-discussed and long-delayed guidance on the appropriate use of social media for marketing healthcare products, that is.

Buried deep within the FDA Safety and Innovation Act (FDASIA), signed into law on 9 July 2012 by President Barack Obama, is a provision mandating that FDA issue social media guidance no later than 9 July 2014.

“Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.”

A Challenging Environment

At issue for life science companies is whether they can use the short-form messaging of social media—particularly Twitter and Facebook—to interact with consumers or promote their products without being able to provide a full list of potential risks and contraindications along with the product.

Twitter’s 140-character limit in particular represents a challenging environment for the industry to operate in. For instance, even a simple tweet about a company obtaining FDA approval for a drug-- COMPANY receives AGENCY approval for BRAND DRUG (DOSE) (GENERIC NAME) for use in patients with DISEASE NAME—takes up nearly the entire character limit, leaving little room for instructions-for-use, safety warnings, contraindications or other prescribing information including possible black box warnings. FDA could conceivably find the tweet to be violative of the Federal Food, Drug and Cosmetic Act (FD&C Act) based on its omission of this information, and companies have been loath to test the as-yet-unknown boundaries of FDA’s enforcement discretion.

The agency has been studying—and proposing additional studies about—the use of social media for the marketing of pharmaceutical products and medical devices for years, and has said it is looking to leverage social media tools more for its own purposes going forward to “better inform industry and the public of compliance and enforcement activities.”

FDA will apparently now have two years in which to formulate the guidance before it is found to be in violation of the law.

Read more:

FDASIA – Title XI – Other Provisions, Subtitle C, Section 1121




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