Includes use of Digital/Social for this Purpose
The FDA quietly issued a 15-page draft guidance on December 28th 2011, outlining how manufacturers could respond to solicited and unsolicited requests for off-label information. The draft addresses both private requests, such as one-on-one communications, and requests made in public forums – such as conferences, product websites, blogs, forums, social networks and discussion boards.
We found some interesting nuances in the FDA guidance and will provide our interpretations for your consideration. However, no matter how we may read this guidance, it is not substitute for checking with your legal, regulatory and medical teams.
The FDA mentions Digital/Social for the first time in draft guidance and addresses responding to off-label requests online
The latest draft guidance is the first time the FDA has:
- Mentioned specific digital/social media channels in draft guidance
- Addressed off-label information on the internet, when it comes to unsolicited public requests
While the draft guidance contains direction for public off-label communications, many have noted the ambiguity of the directive. It provides little additional guidance beyond currently approved practices for the medical industry. Essentially, the FDA has just officially put guidance in place specifically for digital/social channels, or “emerging media.”
Public requests for off-label information are those made on channels that are viewable to the general public.
The FDA has three main concerns for public off-label requests: 1) Individuals currently requesting off-label information online may receive incorrect information from others, 2) by answering a question in public online, the firm may respond in such a way that an unapproved use may somehow be communicated to others who did not request information, and 3) because material can reside on the internet for a long time, the agency worries that outdated information will remain online even when new risk information becomes available. So what does this mean?
Here the FDA has provided some examples of how they would envision firms [the term “firms” is used to indicate pharmaceutical, biotechnology, device and diagnostic companies] engaging with off-label requests online: Should a consumer post an unsolicited PUBLIC request, asking if a specific product can be used for a particular condition, the firm that makes that product can respond to this off-label request.
However, should a consumer pose a question such as “What drug is good for condition X?” and the firm manufactures a drug or a device/diagnostic that is NOT YET cleared for condition X, the firm is not allowed to respond because the question is not specific to their drug. Furthermore, the firm should not respond to requests surrounding competitor products.
Should the firm decide to respond to this PUBLIC, unsolicited request in a digital medium; the following rules provide guidance within already current standards:
- The firm should respond only when the request pertains specifically to its own named product (and is not solely about a competitor’s product)
- The response is limited to providing the firms contact information and should not include any off-label information
- The firms’ public response should ensure that the question pertains to unapproved or uncleared use of its product and that the consumer can contact the firms’ medical affairs or scientific department for more information
- The firm provides specific contact information for the people or department that the consumer can use (Email, Telephone, Address, etc.)
- The firm keeps records of all correspondence and communication
- The representative of the firm responding should be completely transparent as to their relationship with the firm and the response itself should NOT BE PROMOTIONAL in nature or tone
The most critical piece of information regarding public requests exists near the end of the document, where the FDA notes that communications within the above guidelines would not be considered a violation of law:
“If a firm responds to public unsolicited requests for off-label information, including those encountered through emerging electronic media, in the manner described, FDA does not intend to use such responses as evidence of the firm’s intent that its product be used for an unapproved or un-cleared use. Such responses also would not be expected to comply with the disclosure requirements related to promotional labeling and advertising.”
However, the guidance goes on to state that:
“Firms may choose to respond to unsolicited requests for information about off-label uses of their approved or cleared products in a manner other than that recommended in this draft guidance. Such activity would not constitute a per se violation of the law, but could potentially be introduced as evidence of a new intended use.”
This means that if a company chooses to respond in a way other than what is mentioned above, while not a direct violation of the law, those communications can be construed as evidence of intended use in unapproved or uncleared use, so be careful.
The FDA defines “non-public” as private communications a firm may receive, including mail, e-mail, telephone or through firm-controlled websites. The following guidance reinforces current FDA regulation for these private communications:
- Information distributed in response to an unsolicited request should be provided only to the individual making the request directly to the firm as a private, one-on-one communication
- Information distributed should be tailored to answer only the specific question(s) asked
- Information distributed should be truthful, non misleading, accurate and balanced
- Information distributed should be scientific in nature
- Responses should be generated by medical or scientific personnel independent from sales or marketing departments
- The firm must keep records of all correspondence and communication
- Information distributed in response to an unsolicited request should be accompanied by the following:
- A copy of the FDA-required labeling, if any, for the product
- A prominent statement notifying the recipient that FDA has not approved or cleared the product as safe and effective for the use addressed in the materials provided
- A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product
- A prominent statement providing all important safety information including, if applicable, any boxed warning for the product
- A complete list of references for all of the information disseminated in the response (e.g., a bibliography of publications in peer-reviewed medical journals or in medical or scientific texts; citations for data on file, for summary documents, or for abstracts)
What does it all mean?
With this draft guidance, the FDA has opened the door to allow manufacturers to respond to public requests for off-label information online, with specific guidelines that companies already follow in regards to off-label communications.
We suspect that most firms will not take advantage of this as the time and cost involved in monitoring the entire web for off-label requests, and then responding to them, is probably not justifiable. Furthermore, many have noted the ambiguity of the guidance – much of it can be left to interpretation, which may lead to increased caution.
At the least, we believe that this guidance shows that the FDA is continuing to think about digital/social and this document may give insight into what we may see from the agency in 2012.
We recommend that clients weigh the potential costs involved in monitoring for off-label requests with the return on investment it would provide and if the decision is made to engage in these types of requests, to take the same precautions in responding as they would in any traditional forum. We expect to see further guidance from the FDA in 2012 regarding digital/social media and are cautiously optimistic that it will provide the specifics the industry expects. We will keep you posted.