COVID-19 Patient Support Program

  • We have general COVID-19 resources that we would like to share via our Patient Support Program. We would send as information only to enrolled patients. This would be done using Corporate branding and no product mention. Please advise if PAAB review is required.

  • Hey @SKW,

    If the sponsor is creating content and distributing through a patient support program, the content should be reviewed. While it may appear unbranded because there is no product mention, it is being distributed to patients through a branded program. Review should occur to ensure that the message is non-promotional and consistent with the limitations of the products TMA.

    Due to the time sensitive nature of COVID-19 content, we can do our best to expedite the review if you notify admin to flag the file.

  • @Jennifer-Carroll Good morning, We are not creating the content it is independently prepared and provided to us.

  • @SKW

    If independent third party content on COVID-19 is being provided to a patient through a branded patient support program, an assessment of the linkage should be performed to ensure the acceptability of the content within the context of the brand. This remains true even if being sent without the brand logo (i.e. they are being sent the content because they are part of the branded patient support program). PAAB would do an assessment of the linkage to the content which could be done through an opinion file and would be subject to the four day turn around time.