FAQs on FDA’s New Draft Social Media Guidance for Prescription Drugs and Biologics
On January 13, 2014, the FDA issued a Draft Guidance entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.” This long-awaited (and long-delayed) Draft Guidance explains how FDA intends to regulate statements about drugs and biologics in various forms of social media. The Draft Guidance is required under Section 1121 of the Food and Drug Administration Safety and Innovation Act (FDASIA) where Congress required the FDA to set forth its policy regarding the promotion of medical products using the Internet, including social media, within two years from the date the Act was signed (July 9, 2012).
What Products Are Covered?
- Human Prescription Drugs
- Animal Prescription Drugs
What Firms and Individuals Are Covered?
- NDA or ANDA applicants/sponsors
- NADA or ANADA applicants/sponsors
- BLA applicants/sponsors
- Employees or agents acting on behalf of the above applicants/sponsors, including sales representatives, medical science liaisons (MSLs), and paid speakers (key opinion leaders)
What are examples of social media covered by the FDA’s definition in the Draft Guidance of “Interactive Promotional Media”?
- Product websites
- Social Networking Sites
- Online communities
- Live podcasts
- Discussion boards
- Chat rooms
What happens if the “Interactive Promotional Media” is owned, controlled, created, influenced, or operated by, or on behalf of, a pharmaceutical company?
The pharmaceutical company must submit all content to the FDA with a Form FDA 2253 (or a Form FDA 2301 for animal drugs).
What happens if the “Interactive Promotional Media” is not owned, controlled, created, influenced or operated by, or on behalf of, a pharmaceutical company — i.e., third-party sites?
If the pharmaceutical company only provides financial support through an unrestricted educational grant, then, generally, the company does not need to submit the content to the FDA.
If, however, regardless of the lack of financial support, the pharmaceutical company has any control or influence on the third-party site (including collaboration, or editorial, preview, or review privileges), then content must be submitted to the FDA.
If the pharmaceutical company merely provides promotional materials to a third-party site but does not direct the placement of the promotional materials within the site and has no other control or influence, the company only needs to submit to the FDA the content it places on the site. If, though, the company makes suggestions on the placement of the promotional materials, then the surrounding pages must also be submitted.
Is User Generated Content — UGC — covered?
Yes for UGC that consists of communications of employees, or agents, or third parties acting on behalf of the company.
UGC that is truly independent of the company even on company-owned or company-controlled venues such as blogs, message boards, and chat rooms is not covered as long as the company has no influence over the UGC.
How should companies submit “Interactive Promotional Media” to the FDA?
Static promotional materials (e.g., sites that do not allow real-time communications and emails with predetermined content) need to be submitted at the time of first use. If the company then updates one page or one section of the static product materials, the company can submit only the updated page or section with a cross-reference to the original submission.
“Interactive Promotional Media” sites for which a company is responsible should be submitted at the time of initial display and should include annotations to describe the interactive parts. Any subsequent changes should be annotated and resubmitted, with a cross-reference to the submission date of the most recent version of the site. However, if the site is publically accessible without restrictions such as a password or subscription (“non-restricted”) and remains unchanged other than displaying real-time information, the company need only submit once a month an updated listing of the site and need not include screenshots or other content. If the site has restricted access, the company should submit all content related to the discussion (all UGC about the topic) every month.
For third-party sites on which the company’s participation is limited to interactive or real-time communications, the company should submit, at the time of initial display, the home page along with the interactive pages within the site and the firm’s first communication. After the initial submission, if the company remains an active participant and the site is “non-restricted,” the company should submit once a month an updated listing of the site but need not include content or screenshots of the UGC. For “restricted” sites, the company should submit screenshots and other visual representations of the site including the UGC every month.
If you have questions concerning this Draft Guidance or would like assistance in submitting comments to the FDA, please contact Wayne H. Matelski, James R. Ravitz, Brian P. Waldman, or Joanne S. Hawana.