FDA Guidance for Pharma on Social Media and Off-Label Use

The pharmaceutical industry has been waiting (and waiting, and waiting) for guidance from the United States Food and Drug Administration on what is and isn't allowed in terms of social media communication and marketing.  Now just a little has come through - but is it of any help?  We think not much ...

In November 2009, the Federal Drug Administration held a public hearing on its intention to issue guidance to companies on the FDA’s approach to regulating the promotion of medical products on the Internet and through the use of social media tools.   The speakers included representatives from major pharmaceutical companies, social media and pharmaceutical experts, patient and user advocates, and watchdog groups.  Dropped from 2010's FDA Guidance Agenda, the topic of "Promotion of Prescription Drug Products Using Social Media Tools" was delayed, with an expected delivery of first quarter of 2011.

 

Regulations concerning off label use

The existing regulation on off-label use prohibits a pharmaceutical or medical device company from promoting its product for a use other than that previously approved or cleared by the FDA.  But once a product has been approved by the FDA for use, the product can be used by healthcare professionals for purposes not included in the product labeling:  thus, “off-label” use.

In late December 2011, the FDA issued the guidance "Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices." The guidance addresses a targeted topic within consumer/Pharma communication, but with direct application to social media communications.

In summary:

- The guidance does not change or otherwise effect existing regulations.  Rather, it offers more information on interpreting existing regulation.

- Called in the media “draft social media guidance”, this particular guidance does little to address overall social media use by pharmaceutical and medical device companies and consumers.  It does recommend how social media should be used in an off-label context, but the recommendations follow existing regulation that companies in the industry already zealously follow.

- Pharmaceutical and medical device companies already have systems and pathways in place for requests for information of off-label uses of approved products.  The guidance suggests that requests that come from social media should follow existing pathways as long as they comply with federal regulations.

- In regards to any company communication about off-label uses for approved products, the industry must continue to remain vigilant and avoid even the accidental appearance of promotion.  This tenant has not changed from existing regulation.

- The guidance makes clear that a company may choose to respond to an unsolicited request for off-label use information, but is not required to respond.  This distinction adds welcome clarity to the "policing the Internet" issue brought up in the 2009 hearings and gives the company leeway to intervene in a limited way with a potential spread of misinformation.

- If a company chooses to respond and does so in a way that honors the guidance, the FDA states that it will not use the response as evidence of the company’s intent that the product be used for an unapproved or uncleared use.

In detail:

  

Defining "Solicited Request" in Terms of Social Media

The guidance covers not only nonpublic unsolicited requests – ones “directed to firms privately through one-on-one communications” – but also public unsolicited requests.  And this is where social media comes into play, because the venue where a public unsolicited request might be made that would have the widest audience and the largest ripple-effect consequences is what the guidance calls “emerging electronic media,” i.e., social media and the Internet. 

The draft guidance offers the following scenarios in which social or online media might be a factor in which a request for off-label use information would be perceived by the FDA to be a solicited request:

URLs

If the company provides for contact a uniform resource locator (URL), or username that is a word, alpha phrase, or alpha representation implying the availability of off-label information for its product, requests using this phone number, e-mail address, URL, or username would be considered a solicited request and against current FDA regulation.

An example of this might be www.BeatConditionX.com, or for a user id handle on a forum, chat, or social media network: Condition_X_Hurts_Drug_Y_Helps, with Condition X being something for which Drug Y has a documented off-label application.

Third-Party Sites

If the company requests individuals to publicly submit via a third party site information on their own uses of a drug or device, if the information is posted about an off-label use and then questions arise about that that off-label use, those questions would be considered a solicited response.

Therefore, if a social media You Tube campaign involving a drug or device asked for user-generated content about use and a video were posted about an off-label use, questions about that specific video would be viewed by the FDA as a solicited request for off-label use information.

Bloggers

In the guidance, solicited bloggers are treated as extensions of the promotional arm of a company, so if a campaign involved sending materials to bloggers who then blogged about off-label use, any request, be it direct to the company via a private channel or on the blogger’s third-party comment system, would be considered a solicited request.

Microblogging

In the guidance, Microblogging or tweeting is given the same gravitas as any other form of publishing or broadcasting. 

For example, if an organization announces or “tweets” results of a study via a microblogging service (e.g., Twitter) and suggests that an off-label use of its product is safe and effective, any comments and requests received as a result of the original message about the off-label use would be considered solicited requests.

Online FAQs and Knowledgebases

If an organization stores information about off-label use online and makes that information available via self-learning, any request for information about an off-label use that originates from this will also be considered solicited.  The specific example used in the guidance for this tenant is one of drop-down menu choices that provide prepared standard responses about diseases or drug use also including or leading to a knowledgebase item about off-label use.

Responding to Public, Unsolicited Requests for Information about an Off-Label Use of Product or Device

The FDA’s concern with the permanence of statements made online can be seen in its recommendations for responding to public, unsolicited requests for information about an off-label use of a product or device.  In the guidance, the FDA expresses concern for the permanence of material posted publicly online, as information about a drug or product may become out-dated over time, the availability of information posted publicly online intended for one party but read by another, and that the posting of the information could be viewed as promoting an unapproved use of a product or device.

With the above in mind, the FDA recommends the following when responding to unsolicited, public requests for off-label use information:

 

• A company should respond only when a public query is made regarding its specific product (Does Drug X treat condition Y?) and not respond when the query is made about a class or category of product of which a company may have a matching product (Does this kind of drug treat condition Y?  What device can help with condition Y?)  This point is valid no matter form of emerging electronic or social media the request is publicly published.
• In its response, a company should provide only contact information publicly and provide the rest of the information privately in a closed communication loop.
• A company in its public response should convey that the question pertains to an unapproved or uncleared use of the product.
• A company in its public response should state that individuals can contact the medical/scientific representative or medical affairs department with the specific unsolicited request to obtain more information.  (The guidance specifically states that the sales/marketing departments should not be responsible for dispersing this information, nor should any address or material be used that is promotional in tone.)
• Representatives who provide public responses to unsolicited requests for off-label information should clearly disclose their involvement with a particular firm.

 

After an individual who originally made the request via a public channel makes the request again via a private, one-on-one communication, the guidance recommends following the existing procedure for documentation regarding the dispersal of off-label use information.

If responses to unsolicited requests fall within these parameters:  that the information provided be truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request, even if responding to the request requires a company to provide information on unapproved or uncleared indications or conditions of use, the guidance makes clear that it is unlikely that the FDA will apply regulatory requirements for promotional labeling or advertising and/or consider these responses as evidence of intended use as long as the off-label use information is delivered privately to a specific individual and in a one-on-one communication.

 The FDA still apparently intends to publish guidance or regulatory information on the topics originally on deck for 2011, including: fulfilling regulatory requirements when using tools associated with space limitations, fulfilling post-marketing submission requirements, on-line communications for which manufacturers, packers, or distributors are accountable, use of links on the Internet, and correcting misinformation.

  

While any information regarding social media use for Pharma at this point is appreciated, the FDA’s recent published guidance regarding off-label use leaves a conservative industry with even more qualms about using social media for interaction and information sharing.

 

Further reading: 

Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices, FDA, December 2011

eModeration's August 2011 blog post regarding Facebook’s about-face with pharmaceutical companies and comment white listing.