FDA Issues Draft Guidance for Pharma & Medical Device Makers’ Use of Social Media

FDA Issues Draft Guidance for Pharma & Medical Device Makers Use of Social Media   social media marketing social media communication social media pharmaceutical pharma mobile healthcare regulations mobile healthcare mobile health regulation mobile health guidelines mobile health mhealth regulation mhealth guidelines mHealth healthcare social media communication healthcare communication Food and Drug Administration FDA guidelines FDA Draft Guidelines FDA draft guidelines The Food and Drug Administration recently published draft guidelines for pharmaceutical and medical device companies on the use of “emerging electronic media,” A.K.A. social media marketing and communication.

Though the FDA notes the proposed guidelines aren’t comprehensive and rather the “first of many planned guidance initiatives,” the move marks the first time the FDA has clearly addressed rules for Pharma and medical device makers’ digital communication via social media and other channels — even specifically mentioning services like Twitter, Facebook and YouTube.

The first round of proposed guidelines stipulate that pharma and medical device companies provide only “ fair, non-promotional information to questions posed over social media.”  Such communication does not have to follow the strict requirements of direct-to-consumer advertising, however.  The regulations are strict in terms of how information is relayed and who does the communicating.

The draft guidance is open to public comment until March 26th.  The full draft guidance PDF is available for download here.

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