4 Replies Latest reply on May 24, 2016 8:43 AM by Jennifer Kelley

    How to handle community discussion in dual-use/somewhat-regulated environment?

    jkurutz

      Hi all,

       

      My analytical chemistry instrumentation community is preparing to expand into regulated markets: pharma & biopharma, forensics, and clinical testing. We're definitely steering clear of anything close to patient data in the community, but internally there's concern about compliance with US Federal labeling requirements when it comes to medical devices. Most of our products are used in basic research and technical settings that don't need U.S. FDA regulation, but we do sell some versions of the same instruments that are labeled "For in vitro diagnostic use". The "dual-use" hardware and software are the same as "unlabeled" versions, so discussions of their maintenance and use are mostly the same; the difference lies in the extra certification of the diagnostic versions.

       

      To comply with regulations, my company is starting to require that all materials appearing on our websites be reviewed before they are posted to ensure they are not making inappropriate claims about diagnosing disease - including all posts to social media, hence our community.

       

      There's a possibility that they may ask us to send them every customer post, comment, reply, document, blog, etc. to them for review before it can go live. Review takes 3-10 days with their current staff.

       

      Does anyone else work in a dual-use environment? Do you have any insights into how to maintain a lively community? It seems a waste of time to review all posts as if they concerned medical diagnosis when most discussion is about basic research and finding the part number of an obscure O-ring. Any tips on how we can convince our compliance people that we'll just add terms to our T&Cs, monitor posts like we normally do, and remove ones that are inappropriate?

       

      Thanks. - Josh

       

       

      APPENDIX: Use cases

      1. Not a regulation concern: A scientist in a research lab using the equipment to purify chemicals produced by a new chemical reaction wants to discuss how best to purify the products
      2. Possibly a labeling regulation concern: A pharmaceutical company quality control technician wishes to discuss in general terms the best way to quantify trace  impurities in powdered pharmaceutical samples
      3. Definitely a regulation concern: A clinical researcher in a hospital wished to discuss best practices for validating a new experimental diagnostic method using the version of a device that is labeled "For in vitro diagnostic use"
      4. Concern???: The hospital technician running diagnostic tests is looking for best ways to change an O-ring on the instrument - a routine maintenance function unconnected with diagnosis

       

      In regulated situations, the instrument may be labeled "For In Vitro Diagnostic Use", and in general lab situations it would be labeled "Research use Only". The only real difference between them is that the diagnostic instruments must be certified to pass certain tests.

        • Re: How to handle community discussion in dual-use/somewhat-regulated environment?
          Billy Volpone

          Love using T&Cs for this Josh... good call there. Also, you could leverage e-discovery to find whatever you might need when you need it specific to certain content or posts. Even further, you could enable full HIPAA compliance which would provide data encryption at rest and records retention. Hopefully since there isn't patient information you won't require the latter, but the former is a good start.

          • Re: How to handle community discussion in dual-use/somewhat-regulated environment?
            jkurutz

            UPDATE:

            The FDA does not appear to have definitive guidelines concerning community discussions of regulated products, but in June 2014 they published a Draft set of guidelines and asked for comments:

            http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm401079.pdf

            Title: "Guidance for Industry Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices DRAFT GUIDANCE"

             

            The text suggests that FDA recognizes that companies cannot be held responsible for user-generated content. The regulatory focus is thus shifted to identifying when a company is and is not responsible for correcting misinformation, keeping in mind that the company has little or no control over what independent parties say about their products. With respect to company-hosted forums, it provided an interesting example:

            "141    Example 4: A firm hosts a discussion forum about its drug’s or device’s FDA-approved

            142     use on its corporate website and does not participate in the discussion, but it does monitor

            143     the forum for profanity and obscenity. The forum includes an overarching clear and

            144     conspicuous statement that the firm did not create the content of the forum. The firm is

            145     not responsible for the information that is posted by independent third parties and can,

            146     if it so chooses, correct misinformation according to this guidance."

             

            While informative, this example still does not precisely indicate the responsibility of the company if employees actively engage customers in discussions. A reasonable precautionary approach on our part would be to allow customers to post freely, but monitor for any claims of medical relevance, and engage the customers on those points. This seems like good practice anyway, but whether we are legally bound to do so remains an open question.

             

            Let's hope this gets resolved soon. The comment period, during which a couple of industry groups made some useful suggestions for improving clarity, was closed in October 2014, so it seems definitive guidance is overdue.

             

            If anyone knows of additional regulatory guidance, please post it here. Thanks. - Josh

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