It’s been nearly five years since drug makers and other in the industry were promised FDA-approved guidelines as a part of the Prescription Drug User Free Act (section 1121.) For many drug companies, the lack of guidelines has hindered their marketing outreach due to fear that any participation in social media (or online advertising for that matter) could result in fines or penalties based on unclear policy and regulation. This week, the FDA released a 10-page document that outlined the first in what promised to be more concise guidelines for the industry, which are due in July of this year as a part of the 2012 FDA Safety and Innovation Act (FDASIA) which requires the agency to “issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products” that it regulates. The bulk of the drafted guidelines still focuses on the POSTmarketing requirements that have long been in question with regard to social media and online advertising.
Following are the key points that you need to know.
- The FDA has for the first time committed itself in the document to not holding advertisers responsible for things they don’t control. (James D. Dickinsen originally reported.)
- The definition of “promotional labeling” says no physical relationship between the promotional words and the product is necessary.
- The FD&C Act requirements for postmarketing submission have been softened a bit. The FDA recognizes that the regulation requiring submission of content and location of promotional materials at the time of production isn’t always possible in an online world. That being said, they will lighten up on submission requirements and allow more “discretion.”
- That being said, according to Medical Marketing & Media Magazine, “In the case of user-generated content, the draft guidance says FDA will “exercise enforcement discretion” (read: take no enforcement action) if firms participating in such discussions one of five steps: (1) Submit all sites in their entirety on Forms 2253 or 2301 at the time of initial display; (2) in the case of a firm’s interactive or real-time communication on a third-party site, submit the home page, the interactive page and the firm’s first communication on either form at the time of initial display; (3)submit monthly updates of all non-restricted sites for which the firm is responsible; (4) submit all content from restricted sites that is related to the discussion, making sure the report accurately reflects the context; and (5) ensure that site submissions take formatting factors into consideration “to enable the agency to view the communications as a whole.”
- You are still required to submit marketing materials that will be utilized online are in any way under your control. This includes of course your Twitter, Facebook, and other blogs and sites. They further explain the scope of “controlled content” to include any site where you have ANY editorial input, interview, or approval in the process of publishing. The document gives some specific examples, but to break it down simply: if you publish the content and have any editorial control or interaction with the content, then you have to report the content AND the ongoing interactions to the FDA under the current process. If you are ONLY providing content (or financial support) for a website (as an example) but no other authority over placement, timing, or the like, then you only have to report the ORIGINAL content.
- A firm IS responsible for employees content placed on sites if it’s in any way deemed promotional. The way the draft is written reads more like FINRA regulation which makes a firm liable for ALL communication, even conducted outside of the office. So to be safe, continue with current UCG and communications of employees or “anyone acting on behalf of the firm” when it comes to content being posted about your company or product. This includes sales people, paid speakers, content created by your social media firm or ad agency, and the like.
- If you are being covered in a blog, or asked to guest blog, you are required to submit the material. You can answer the transparency “suggestion” by simply having the proper byline or logo with your name.
- You should submit Form FDA 2253 or Form FDA 2301 for the non-restricted sites on a monthly basis. (This is better than the previous “as it happens” criteria.) For websites, you can include screen grabs or a document with the URL, date range, etc. If the site has restricted access (behind a user name and password for example) you MUST submit screenshots. Don’t forget to update these monthly IF there was any continued dialogue.
- And they ask you to submit your forms in a pretty fashion. No, I’m not joking. They ask you to “take formatting factors into consideration.”
There will surely be more to come down the line. But for now, the parameters are at least a little bit more defined.
Amanda Vega, CEO
Amanda Vega Consulting
PR, Social Media and Compliance