Eliminating the Disparity in 2253 Filing Requirements

One of the difficulties with the guidance on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (or the 2253 guidance as I call it*) on social media is that it establishes a distinction in filing requirements between forums that are publicly accessible and those that are not.

Sponsors of prescription products who wish to engage in social media are granted two pathways via this guidance for meeting their 2253 filing requirements, which is the obligation to submit all promotional materials at the time of first use or prior to initial dissemination.

For forums that are publicly accessible, sponsors can submit the initial communication on a third-party site, along with any home or profile page, and the URL where the real-time communications will occur. Then, every month, firms should submit the list of all URLs where it is engaging in real-time communications.

However, forums that are not publicly accessible have a different requirement. Instead of merely submitting a list of URLs each month, FDA requests that sponsors who choose to use such forums submit screenshots of the interactions that occur.

It has been pointed out by others (including yours truly) that this distinction is difficult to understand or draw in practice. For example, many platforms have a minimal requirement that to view any discussions in the platform, you must be a member of (and logged in to your account on) the platform. Would such a requirement be seen by the FDA as making the site not publicly accessible?

Moreover, for third-party sites, this requirement might change without notice. Were that to happen, a sponsor could go from being in compliance to being out of compliance without having themselves made any changes, and that seems odd. It certainly seems that what a sponsor is operating compliantly should not depend on the policies of a third-party site.

Another difficulty is that the disparity in filing requirement is huge and would put a barrier in front of participating in non-restricted forums. Preparing all of the screenshots on a monthly basis could be a significant undertaking depending on the volume of the communications in the forum. While that might seem desirable at first blush, there are good reasons to want to operate such closed forum. Such forums enable, for example, full verification of credentials prior to admission. That means that information can be more freely shared without concern that people who should not have access to the information might receive it. For example, if I were the sponsor of a pain medication, I might want to discuss methods that some patients are using to circumvent abuse prevention mechanisms, but obviously I would not want that information to be available in a publicly accessible forum.

The essence behind this requirement seems to be the desire of FDA to monitor the real-time communications and to rely on the possibility of FDA monitoring of communications to ensure that all communications are appropriate.**

One way of addressing these concerns and eliminating the disparity in filing requirements is to require that when sponsors make use of third-party platforms with restricted access that they set up credentials for FDA to access the forum.

It would be easy for FDA to create an email address and name (e.g., OPDP Social Media & OPDPSocMed@FDA.gov) that could be created as a user for any restricted access platforms. To further simplify things, FDA could establish and publish a list of its credentials on the most prominent forums (e.g., YouTube, Facebook, LinkedIn, Twitter) for monitoring purposes. In that way, sponsors could simply create a user account with FDA's credentials when they set up their restricted-access forums. The sponsor could then include as part of their initial 2253 filing requirement a password (if required) for FDA to access the forum.

From that point forward, sponsors would then be on equal footing with the requirement simply to file monthly reports indicating their continued involvement in the platform but not being required to submit screenshots of all of the interactions.

This method would enable FDA to monitor the conversations in real-time without creating a disparity in filing or a barrier to establishing and maintaining restricted-access forums. It also would ensure that changes made by third-parties could not cause a sponsor to find themselves out of compliance with FDA requirements.


* It is worth noting that the guidance also affects filing of FDA Form 2301 for veterinary medicines. Nothing in this post is affected by this nuance.
** Quoting from the guidance, "if a site has restricted access and, as such, FDA may not have access to the site" (page 7, emphasis added)



No comments:

Post a Comment