Medical Products Promoted Through Social Media: FDA to Issue Guidance

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A customer loads Pfizer's Facebook page and leaves a comment on a wall post asking about an off-label use of one the company's products. How should the pharmaceutical company respond, if at all? That issue is one of the many topics to be addressed in guidance the Food and Drug Administration is required to issue within two years. Section 1121 of the Food and Drug Administration Safety and Innovation Act (S. 3187), signed into law by President Obama on July 9, tasks the agency with issuing guidance on its policy "regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration."  The forthcoming guidance is essential for the current generation. The developing social media and internet media are different from broadcast and print. They reach a global audience, can exist indefinitely,and are an active dialogue between people.The most contentious issue will be how companies should respond to off-label questions posed on social media platforms. Almost everyone objected to the FDA's stance in a December 2011 draft guidance that companies respond privately to any question on social media that addressed off-label uses.

The FDA had noted that it may be true "that the original, unsolicited off-label question may have been available to a very broad audience." Nonetheless, "the firm should not make its detailed response with off-label information publicly available within the same forum." The issue is important because federal law only permits companies from promoting a drug or medical device for uses that have received FDA clearance. The FDA also has not been hesitant to issue warning letters to companies it believes have engaged in improper off-label communications through social media.

Draft guidance.

FDA Looking to Overhaul Compliance Approach

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An article published in Regulatory Focus gives FDA's latest thinking on the relationship between Compliance and Quality.

In a presentation to the Regulatory Affairs Professionals Society's (RAPS) San Francisco membership chapter on 27 July 2012, Roh, regional food and drug director for FDA's Pacific Region, said the US Food and Drug Administration (FDA) is heading towards a significant change in compliance policy in the coming years. This is a result of rapidly surging imports of pharmaceutical, medical device and biologics products. Under the new system, stand-alone compliance issues would become secondary in importance to quality systems put in place by companies.

The rate at which products were being imported from overseas manufacturing facilities was fast outstripping FDA's ability to effectively exercise oversight. Some of the largest US trading partners are projected to experience enormous growth trends in imports, Roh said in his presentation. China in particular is expected to experience a 426% growth in exports by 2020, while India (+465%) and Mexico (+159%) are projected to exhibit similar percentage increases, though on a smaller overall scale. This could have huge ramifications for the US, which already imports approximately 10% of all products regulated by FDA. The US is expected to see growth rates between 5% and 8% during most years, with estimations going as high as 15% during some years.

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