7/30/2014 … Here is the way it is being pitched,,, but given the track record of gov’t agencies one must wonder what the industry stands to gain after this is implemented…. FDA Issues Social Media Guidance
The Food and Drug Administration has released draft social media guidelines for pharmaceutical companies and medical device manufacturers in which they emphasize that despite limited space, risk information must be adequately conveyed.
The agency issued two documents: “Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices” and “Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.”
The overarching principle for the FDA: communicate risk information to consumers and provide a balanced presentation. “Risk information should be comparable in content and prominence to benefit claims within the product promotion,” the agency wrote. “Achieving a balanced presentation requires firms to carefully consider the desired benefit claims and risk profiles for their products when choosing a promotional platform.”
While the guidelines recognize the space constraints on social media – Twitter’s 140-word limit, for example – they nonetheless state that drug and device companies must still disclose product risks and indications in every communication, from a tweet to a Facebook post. Where possible, font and formatting should be used to highlight risk information.
If the allotted space doesn’t permit the listing of all possible risks, the FDA said companies should prioritize, leading with boxed warnings and fatal risks. Also important: provide a link to a source for more complete information about the drug or device and its risks. The agency approved the use of short links as another space-saving measure, but recommended that the link indicate the landing page’s information and refrain from using the truncated link as a promotional opportunity.
And if space constraints preclude the listing of reasonable disclosures, companies should reconsider the social media platform being used, the agency advised.
The FDA, as an example, recommended the following tweet for fictional prescription drug, NoFocus, to treat mild to moderate memory loss and may cause seizures in patients with seizure disorder: “NoFocus (remembrine HCl) for mild to moderate memory loss – may cause seizures in patients with a seizure disorder www.nofocus.com/risk.”
In the second document, the agency acknowledged the interactive nature of social media and the need for manufacturers to correct misinformation on the Internet. But when attempting to correct mistakes (like on a discussion forum), companies should self-identify, provide the correct information, and refrain from using the posting as a promotion opportunity.
The guidelines offered several examples of when and how to make corrections, including a situation where a firm corrects misinformation posted on a blog that allows comments. In the hypothetical, the company corrected the misinformation but failed to address other postings that state exaggerated efficacy claims for the product.
“Even if the firm corrects the misinformation in the limited posts it chose, the firm’s actions are not in accord with this guidance because it has intentionally selected only negative information about its product to correct while readily accessible and visible positive misinformation was not corrected,” the agency noted.
To read the FDA’s draft guidance on social media marketing, click here.
To read the draft guidance on correcting misinformation, click here.
Why it matters: The guidance focuses on the FDA’s interpretation and expectation of how companies will promote their products in social media. The draft guidance is nonbinding and remains to be finalized. However, pharmaceutical companies and device manufacturers would be well-advised to familiarize themselves with the documents if they are planning to promote their products on social media, especially as the issuance of draft guidance could indicate an uptick in the FDA’s enforcement efforts. Manufacturers should review their social media current policies and procedures, decide whether to submit their marketing materials to the FDA, and determine whether to provide comments and suggestions to the FDA before the August 18 and September 16, 2014, deadlines. (from: http://www.jdsupra.com/legalnews/advertising-law-july-2014-48048/)