@Larry Lugo,does your company have Social Media Policies and Procedures, and guidelines for expectations around specific types of platforms? If not, you'd be wise to assemble a multidisciplinary team asap in order to develop such SOPs and guidelines, and be sure you get buy-in from senior management (management committee) to ensure sufficient resources will be in place to undertake all activities around social media. SOPs and guidelines should include, among other things, expectations for handling product complaints and adverse events (including timelines for responding real-time). Your guidelines should include prepared responses to various scenarios. For example, if you are accepting user generated content (UGC) and a user posts a use that is off-label, you should have a prepared response that acknowledges the use the user described is off label, what the approved indication is, and any other pertinent information. You should also have guidelines for dealing with filing 2253s if any of the content your company will be posting is branded content. Finally, your guidelines should clearly spell out who is responsible for monitoring the platforms for any UGC to ensure complaints and AEs are reported and investigated timely.
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Linda Pollitz RAC
Senior Director, Regulatory Affairs, Advertising & Promotion
Bedford MA
United States
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Original Message:
Sent: 13-Dec-2018 09:43
From: Larry Lugo
Subject: Ask Me Anything Session: APL
Our issue remains providing guidance to marketing on the use of social media with respect to claims and defining a good process to monitor social media for customer feedback. The challenge is not to be overly restricted, but not to expose the company to unnecessary risk by not being able to appropriately monitor the wider expanse of feedback channels.
Specifically, our MarCom folks want to be active on Facebook, Twitter, Instagram, as well as our own website. This includes posting relevant news related to Women's Health, as well as our own commercially-focused events. While I agree that social media is a great tool for marketing and awareness, they also are portals for customer feedback. Should someone post feedback, positive or negative, on one of our sites, we have an obligation to put that feedback into our Customer Feedback "box" for review by the Quality Team. If someone were to post, regardless if the incident is true or not, that one of our products malfunctioned, we would have an obligation to review and make an AE determination for any regulatory follow-up. This is one of the problem areas....how to ensure that the various channels are being monitored actively enough to ensure we are atop the feedback loop enough so we can respond within the appropriate time frame. I relate this to APL in that social media is a portal for advertising & promotion. How do we encourage MarCom to leverage social media for advertising & promotion, but also to be cognizant that every time they push something out, they are opening up a channel for feedback that needs to be monitored.
With respect to labeling, if a claim is made on a social media channel, by us or a user, do we have to act if the claim isn't in our indications? For example, if a physician posts about an off-label use of our product, do we ignore it, remove it, or state the mentioned use is off-label. If the latter, you are slapping the hands of a potential use publicly. Perhaps these concerns have been addressed by other users, particularly from smaller companies that have limited resources to actively manage social media. The responses are likely to represent a set of best practices and "lessons learned."
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Larry Lugo
Consultant
Carlsbad CA
United States
Original Message:
Sent: 12-Dec-2018 13:25
From: Emily Stamm
Subject: Ask Me Anything Session: APL
Hi Members,
Recently, RAPS released it's quarterly article series focusing on current trends and best practices in Global Advertising, Promotion and Labeling (APL) regulations. Today, we have five APL experts, @Linda Pollitz, @Julie Batal, @Richard Lem, @Georgina Lee, and @John Wong who will be discussing the articles in real-time and available to answer your questions.
Please use this thread to ask the experts your questions.
Can't wait to read the discussions!
Best,
Emily
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Emily Stamm
Community Manager
Regulatory Affairs Professionals Society®
regex@raps.org
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