FDA releases new off-label social media guidelines

The United States’ Food and Drug Administration (FDA) concluded 2011 by announcing new social media marketing guidelines for pharmaceutical companies.
The FDA released its “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” document, which mentions Twitter and YouTube.

The 15-page guidance document addresses off-label information, telling pharma companies how they should respond to consumers who are looking for information for a prescription drug on aspects outside of its intended use.

Some critics say that the advice given is too ambiguous – a comment that the FDA refutes.

Karen Mahoney, an FDA spokeswoman, said: “We understand the level of interest and wanted to get out what we had available to provide guidance.”

“This is just the first of multiple planned guidances that respond to testimony and comments from the Part 15 public hearing that FDA held in November 2009.”

In the guidance document, the FDA writes: “FDA recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to the most accurate and up-to-date information about the firm’s products.

“Statements that promote a drug or medical device for uses other than those approved or cleared by FDA may be used as evidence of a new intended use. Introducing a product into commerce for such a new intended use without FDA approval or clearance would, under these requirements, generally violate the law.”

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