Recent FDA Guidance on fulfilling regulatory requirements clarifies the agency’s approach on promotional content, raising compliance questions for pharma PR.
Oktavia has years of experience as a pharmaceutical communications professional, so she has a firm grasp on how to walk the narrow path of FDA regulatory compliance. She was managing print and TV ad campaigns long before she started using online and social media channels to promote her current employer, ABC Drug Corp.
So when a user posts some nice comments on Facebook about how his health improved after using an ABC-manufactured diabetes drug. Oktavia doesn’t hesitate before clicking the “Like” button.
And, with that, ABC will be the unfortunate recipient of the dreaded FDA Warning Letter. Wait - what?! How could a little “like” trigger such a harsh response from the agency? This outcome is confusing – even for a seasoned pharmaceutical PR Exec like Oktavia.
She’s not alone: The FDA’s position on postmarketing reporting requirements for online communications had been somewhat murky until the issuance of a recent statement on the matter. While any pharmaceutical firm or marketing agency should always rely on legal experts for the critical details, there are some key points healthcare PR pros need to know.
Summary of the FDA Guidance
In January 2014, the FDA issued a Guidance with a long, complicated name for a relatively simple concept: The FDA wants pharmaceutical brands to report their online communications like they have been for traditional marketing. Specifically, as part of agency’s “postmarketing reporting requirements,” drug firms must submit all marketing materials at the time of initial dissemination and/or publication of the advertisement.
But what does that mean in the online environment, where you might have multiple “publications” per day via social media, press releases, your blog and website. Does that mean reporting every Like, Tweet, Re-Tweet, Share, +1, blog comment and the like – 24x7?
Thankfully, no. But there are periodic submission requirements for what the Guidance defines as “interactive promotional media,” i.e., the modern tools and technologies that involve real-time communications and interactions — e.g., blogs, social sites, online communities and live podcasts.
Submission Requirements Under the FDA Guidance
So how do you know whether you need to file the required FDA forms to report on publication of your promotional materials? Start by asking three primary questions.
- Are you publishing on sites that your firm owns, controls, creates, operates or influences?
This one is relatively straightforward, but the FDA Guidance further clarifies influence as being collaboration, or editorial and review privileges over the content.
- Are you supplying content to promote a product on a third-party site where you have a certain amount of control or influence?
The same criteria apply here for influence: If you’re collaborating or have editorial/review privileges, you must submit a report on publication for the third-party site. Even directing the position of your ad – whether it’s at the top, along the side or on a specific page – will be considered influence.
- Are you generating content through an employee or agent who is acting on behalf of your firm to promote the firm’s product?
This is where Oktavia got ABC Drug Corp. into trouble: She’s an employee that commented on Facebook about the firm’s product, so the firm is responsible for the content provided. Incidentally, AMARC Enterprises was the recipient of a real-life FDA Warning Letter under similar circumstances, showing just how serious the FDA takes its regulatory responsibilities.
Only your legal department has the expertise to answer these questions, but it’s important for pharmaceutical PR teams to know how their activities are viewed by the FDA – so you’re less likely to be caught unawares by a Warning Letter.
By Marc DeLeuw