Federal Drug Administration (FDA) has announced its draft guidance on Social Media in Pharma. What question does it answer and what remains still unregulated? What are the consequences of this guidance and expected next steps?
When finalized this guidance will regulate all Internet activities of pharmaceutical companies operating in the United States. The guidance was long expected by the pharma industry. According to earlier announcements from FDA more comprehensive guidance shall be released by July 2014.
Main proposals of the new FDA guidance for Social Media in Pharma
Pharma companies responsibility for the content published in social media:
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A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.
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Under certain circumstances, a firm is responsible for promotion on third-party sites.
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A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.
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Pharma companies obligation to submit interactive promotional materials to FDA:
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At the time of initial display, a firm should submit in its entirety all sites for which it is responsible on Form FDA 2253 or Form FDA 2301. For example, the firm should submit the comprehensive static product website with the addition of the interactive or real-time components.
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For third-party sites on which a firm’s participation is limited to interactive or real-time communications, a firm should submit the home page of the third-party site, along with the interactive page within the third-party site and the firm’s first communication, on Form FDA 2253 or Form FDA 2301 at the time of initial display.
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Once every month, a firm should submit an updated listing of all non-restricted sites for which it is responsible or in which it remains an active participant and that include interactive or real-time communications. Firms need not submit screenshots or other visual representations of the actual interactive or real-time communications with the monthly updates.
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However, if a site has restricted access and, as such, FDA may not have access to the site, a firm should submit all content related to the discussion (e.g., all UGC about the topic), which may or may not include independent UGC, to adequately provide context to facilitate the review. Screenshots or other visual representations of the actual site, including the interactive or real-time communications, should be submitted monthly on Form FDA 2253 or Form FDA 2301.
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When submitting the site, FDA recommends that a firm take formatting factors (e.g., appearance, layout, visual impression) into consideration to enable the Agency to view the communications as a whole.
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What the industry expected to be addressed? Is it addressed with the new FDA draft guidance?
In general FDA has addressed two of five main points raised by pharmaceutical companies. Those are responsibility for the content published in the Internet and in Social Media, and 2253 Submissions requirements.
Internet control and 3rd party controlled social media responsibility
FDA has defined scope of responsibility for pharma companies. In general pharmaceutical companies are responsible for any content that they have control or influence on. Let us repeat the phrasing of the document:
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Pharma companies responsibility for the content published in social media:
1. A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.
2. Under certain circumstances, a firm is responsible for promotion on third-party sites.
3. A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.
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2253 Submissions
FDA requires all prescription drug labeling and advertising to be submitted at the time of initial dissemination through an FDA Form 2253. [21 C.F.R. § 314.81 (b)(3)(i)].
Until this draft guidance however, it was not clear what are companies obligations for submitting social media content. For the sake of security social media activities were limited to the safe topics and avoided mentions of any product. It may change now, as the guidance states clearly what and when should be submitted to the Agency. While industry may not be happy with the request to feed FDA with all User Generated Content that may be considered promotional, at least now everyone knows what to report.
What is left unanswered by the new FDA Guidance on Social Media in Pharma?
Space limitations and one click statement rule
FDA requires that every promotional material includes comprehensive information about the product, including safety information. Due to space limitation and “hypertexted” nature of the digital media, pharmaceutical industry developed theory of so called “one-click rule”. The assumption was that to meet FDA’s expectation it is enough to provide on the interactive promotional material a link to the website that would include required information.
This has been questioned by the Agency which issued enforcement letters to 14 companies who used Google display advertisement where risk information was available under “one-click”. In the following statements FDA declined existence of any one-click rule, but did not offer any alternative. New guidance does not refer to this aspect of the regulation. Therefore any promotional activities mentioning pharmaceutical products on platforms with limited message space ie. on Twitter are still not possible.
Off-label discussions
Another issue that is not addressed by the guidance is off-label use discussion. Promotional messages may not recommend or suggest the drug for off-label uses. Technically it means that anyone in relation to the company is not allowed to even mention any use of the drug that is not approved by FDA. Any response to such mention in social media by pharmaceutical company may be considered as suggesting and therefore promoting off-label use. As we are discussing here open communication channels available to general public, even scientifically valid and supported by pending trials question about any product use that is not approved has to remain unanswered. This limitation remains in force with the new draft guidelines.
Drug Safety and Adverse Events Reporting
Drug Safety or Pharmacovigilance is probably the most important reason why embracing social media in pharma marketing is so slow. It is extremely important (human life is at stake), and there are too many questions unanswered around it.
The first obligation is to provide possibility to report any adverse event to the public. For websites addressed to US-based audience it is usually solved by adding MedWatch icon/link, or easily available report form. In social media this is much more difficult, as there is no way to include such link in every message.
If the company engages in social media, should not it also proactively monitor this space for any possible adverse events? Companies are obliged to report any AE found within limited timeframe, but there is possibility that report is discovered long after it was posted online. It may be written in exotic language and not recognized immediately.
Another question is if the company is obliged to actively pursue any post that may be adverse event but does not include all necessary information for AER. If that would be the case the workload could be overwhelming. Another complication is when the post mentions generic name of the drug manufactured and distributed by many companies. Shall all of them contact the original poster to find out missing information?
Those questions remain unanswered with the draft guidelines.
What will happen next?
All interested parties can submit their comments to FDA within 90 days from the date of publication in the Federal Register (01/14/2014) to www.regulations.gov electronically or in written form to the addresses provided in the document. We also expect more comprehensive guidance as mandated in FDA Safety and Innovation Act (FDASIA) of 2012. Section 1121 of FDASIA orders FDA to, “issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by the FDA.”.
Although in his e-mail conversation with Regulatory Focus Stephen King, FDA’s spokesman maintains that the guidance released on 13 January 2014 actually meets the statutory requirements of FDASIA, FDA “plans to issue additional guidance for drug and device manufacturers related to the Internet and social media,” Those documents, according to the same spokesman: “Issues with character space limitations, links (the appropriate use of links), and sponsor correction of misinformation about their products disseminated by third parties.” We may then wait longer than expected for full set of regulations, but at least some steps have been done and we know that there is no need to submit every tweet to FDA before publication.
Full text of the FDA guidance: Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics
Federal Register link
