In time for the last night of Hanukkah – some long awaited (draft) guidance on social media. Well, sort of.
According to the FDA:
This draft guidance is intended to describe the Food and Drug Administration’s (FDA or Agency) current thinking about how manufacturers and distributors (firms) of prescription human and animal drug products (drugs) and medical devices (devices) can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off-label information) related to their FDA-approved or cleared products. This draft guidance updates and clarifies FDA’s policies on unsolicited requests for off-label information, including those that firms may encounter through emerging electronic media.
“Emerging electronic media.” You gotta love the lingo.
The rapid growth of the Internet, including social media tools and other emerging technologies, has made it easier for both consumers and health care professionals to quickly seek information about medical conditions and treatments. Many firms have also used emerging electronic media to disseminate product information. As a result, firms may encounter requests for off-label information about their products through product websites, discussion boards, chat rooms, or other public electronic forums that they maintain and over which they have full control. In addition, third-party sites (i.e., websites and other venues that are either entirely independent of a firm’s control and influence or not fully controlled by a firm) also may reveal questions about off-label uses of a firm’s products. These questions about off-label uses are typically directed to users of the site at large, rather than directly and privately to firms. Such posted information is likely to be available to a much broader audience than just the original requester, especially because communication threads (i.e., questions and replies) are often available for an indefinite period of time.
This draft guidance provides FDA’s recommendations to firms wishing to respond to unsolicited requests for off-label information, including both requests made directly and privately to firms and requests made in public forums, including through emerging electronic media. FDA recognizes that firms are capable of responding to requests about their own named products in a truthful, non-misleading, and accurate manner. Furthermore, as these firms are regulated by FDA and have robust and current information about their products, FDA recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to the most accurate and up-to-date information about the firm’s products.
Now here’s the important part:
If a firm responds to unsolicited requests for off-label information in the manner described in this draft guidance, FDA does not intend to use such responses as evidence of the firm’s intent that the product be used for an unapproved or uncleared use. Such responses would also not be expected to comply with the disclosure requirements related to promotional labeling and advertising. 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.
(Note: Bolded remarks throughout this discussion are my own emphasis.)
So, what’s the difference between “unsolicited” and “solicited?” Here’s the FDA view:
Unsolicited requests are those initiated by persons or entities that are completely independent of the relevant firm. (This may include many health care professionals, health care organizations, members of the academic community, and formulary committees, as well as consumers such as patients and caregivers). Requests that are prompted in any way by a manufacturer or its representatives are not unsolicited requests. Two types of unsolicited requests are addressed in this draft guidance: non-public unsolicited requests and public unsolicited requests. Responses to unsolicited requests can likewise be non-public (private) or public.
Non-public unsolicited requests
A non-public unsolicited request is an unsolicited request that is directed privately to a firm using a one-on-one communication approach.
Example 1: An individual calls or e-mails the medical information staff at a firm seeking information about an off-label use. In this case, neither the request nor the response would be visible to the public.
Public unsolicited requests
A public unsolicited request is an unsolicited request made in a public forum, whether directed to a firm specifically or to a forum at large.
Example 2: During a live presentation, an individual asks a question, directed to a firm’s representative but heard by other attendees, regarding off-label use of a specific product. This request is a public request. Similarly, a response by the firm that is conveyed to the same audience as the original question would be considered a public response.
Example 3: An individual posts a question about off-label use of a specific product on a firm-controlled website (or a third-party discussion forum) that is visible to a broad audience. The request could be directed to a firm specifically or posed to users of a discussion forum at large.
This request is a public online request. Similarly, a response by the firm that is visible to the same audience as the original question would be considered a public online response.
FDA considers requests for off-label information that are prompted in any way by a manufacturer or its representatives to be solicited. Such solicited requests may be considered evidence of a firm’s intent that a drug or medical device be used for a use other than that specifically approved or cleared by FDA. Although not exhaustive, the following examples illustrate what FDA generally considers to be solicited requests for off-label information.
Example 4: If a firm’s sales representative mentions a use of a product that is not reflected in the product’s approved labeling and invites a health care professional to request more information, resulting requests would be considered solicited requests.
Example 5: If a representative of a firm, such as a medical science liaison or paid speaker (e.g., key opinion leader), presents off-label use data at a company-sponsored promotional event (e.g., a dinner) and attendees then ask or submit requests for more information, these requests would be considered solicited requests.
Example 6: If a firm issues to health care professionals business reply cards that are intended for use in requesting off-label information, presents statements or contact information in promotional pieces in a manner that solicits requests for off-label medical or scientific information (e.g., “Product X continues to be evaluated in more than 50 trials in a broad range of conditions and patients” and “Call 1-800-… for more information”), or displays a commercial exhibit panel suggesting a new indication (e.g., a sign that reads “Coming Soon, a new use for Product X”), requests made in response to these types of prompts would be considered solicited requests.
Example 7: If a firm provides a phone number, e-mail address, 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 solicited requests.
Example 8: A firm asks or otherwise encourages users to post videos about their own uses of its product on third-party video-sharing sites (e.g., YouTube), which may result in video postings about an off-label use of its product. If the firm’s initial request for posting of videos results in any questions about off-label uses, or if any off-label video posting made in response to the firm’s encouragement of video postings results in questions about the product’s off-label use, these questions would be considered solicited requests.
Example 9: If a firm sends out packets of information to known bloggers or online consumer reviewers and encourages them to write about an off-label use of its product on third-party sites and this then provokes a discussion about that off-label use, any requests inquiring about the product’s off-label use as a result of these blogs, whether posted as comments to the third-party site or directed to the firm, would be considered solicited requests.
Example 10: If a firm announces 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.
Example 11: If a firm sets up a website that enables viewers to read prepared standard responses for the firm’s products that are generated from prefixed pull-down menus naming various disease states, including any standard responses related to off-label uses for the firm’s product, resulting requests for off-label information would be considered solicited. Moreover, if this website makes it possible to use search terms to generate standard responses that go beyond the scope of the product information being requested, including off-label use information, resulting requests for and responses to such a search would be considered solicited requests.
For all of you out there who thought the FDA was going to answer all your questions and solve all your problems relative to social media and regulatory ambiguity, sorry. Here’s what the agency is telling you – just do what makes sense.
Or, put another way:
FDA has long taken the position that firms can respond to unsolicited requests for information about FDA-regulated medical products by providing 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 firm to provide information on unapproved or uncleared indications or conditions of use. If responses to unsolicited requests fall within these parameters, FDA has not expected those responses to meet regulatory requirements for promotional labeling or advertising and has not considered these responses as evidence of intended use. This draft guidance sets forth FDA’s current thinking on this topic, consistent with the Agency’s past policy statements about responding to unsolicited requests.
Now, here’s the fun stuff –
RESPONDING TO PUBLIC UNSOLICITED REQUESTS FOR OFF-LABEL INFORMATION, INCLUDING THOSE ENCOUNTERED THROUGH EMERGING ELECTRONIC MEDIA
While it certainly isn’t news, here’s the conclusion the FDA has reached regarding “the Internet” – The Internet has revolutionized communication, information-sharing, information exchange among systems, and collaboration, enabling consumers to become more proactive about their health and safety. Consequently, the Internet has become a widely used medium for manufacturers and distributors of FDA-regulated medical products to disseminate information.
So stipulated. Now here’s the interesting part
The Internet has also spawned a variety of social media tools that host online content primarily created and published by users other than the intellectual property owner or product manufacturer. In some cases, this online content may not be accurate. Because consumers increasingly use the Internet to search for information about medical conditions and treatments, firms may receive public requests for off-label information about their products through, for example, product websites, discussion boards, chat rooms, or other public electronic forums that they maintain and over which they have full control. Firms may also encounter requests for off-label information on third-party sites (i.e., websites and other venues that are either entirely independent of a firm’s control and influence or not fully controlled by a firm). Questions about off-label use may be directed to the website users at large, rather than specifically to a firm.
FDA recognizes that firms are capable of responding to requests about their own named products in a truthful, non-misleading, and accurate manner. Moreover, because firms usually have robust and current information about their products, it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are made in public forums, especially since other responders may not provide or have access to the most accurate and up-to-date medical product information.
However, because product information posted on websites and other public electronic forums is likely to be available to a broad audience and for an indefinite period of time, FDA is concerned that firms may post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating unapproved or uncleared use information about FDA-regulated medical products to individuals who have not requested such information. In this circumstance, communications to persons who have not requested information may promote a product for a use or condition for which FDA has not approved or cleared. FDA is also concerned about the enduring nature of detailed public online responses to off-label questions because specific drug or device information may become outdated (e.g., new risk information may become available).
Here comes the “guidance” part of the draft guidance:
FDA makes the following recommendations to a firm that chooses to respond to public unsolicited requests for off-label information about its product(s), including those encountered through emerging electronic media.
If a firm chooses to respond to public unsolicited requests for off-label information, 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 level of specificity of the question posed in a public forum is important in determining the appropriateness of a firm responding to the unsolicited request.
Example 13: An individual poses the specific question “Can Drug/Device X be used for Condition Y” in a public forum (and this question is not prompted by or on behalf of the firm). It may be appropriate for the firm to respond as outlined below because the question is unsolicited and specific to the firm’s named drug or device.
However, if an individual poses the non-specific question “What drug/device can be used for Condition Y” in a public communication thread and the firm manufactures or distributes Drug/Device X, which is not FDA-approved or cleared for Condition Y, the firm should not respond to the request because the question is not specific to Drug/Device X.
A firm's public response to public unsolicited requests for off-label information about its named product should be limited to providing the firm’s contact information and should not include any off-label information.
The firm’s public response should convey that the question pertains to an unapproved or uncleared use of the product and state that individuals can contact the medical/scientific representative or medical affairs department with the specific unsolicited request to obtain more information.
The firm’s public response should provide specific contact information for the medical or scientific personnel or department (e.g., e-mail address, telephone number, facsimile) so that individuals can follow up independently with the firm to obtain specific information about the off-label use of the product through a non-public, one-on-one communication.
In other words, a post along the lines of, “Hi Bob. My name is Susan and I work for DRUG COMPANY NAME. I saw your post regarding NAME OF PRODUCT. That is an off-label use of the product. For FDA-approved indications, here is a link to the official FDA label. If you would like to discuss this product at with our medical personnel, please call this toll-free number”
Not rocket science folks. The draft guidance continues:
After an individual has privately contacted a firm for more information regarding an off-label use of the firm’s product, the firm should provide a detailed response and maintain records following the parameters outlined in Section V of this draft guidance. Therefore, any substantive communication about off-label uses for the product, in response to the original unsolicited off-label question, should occur solely between the firm and the individual who made the request. Regardless of the fact that the original, unsolicited off-label question may have been available to a very broad audience, the firm should not make its detailed response with off-label information publicly available within the same forum. For example, after the requestor has contacted the firm and provided a personal e-mail address to obtain an answer to the off-label question, the firm’s detailed off-label response, within the parameters outlined in Section V of this draft guidance, should be e-mailed to the requestor since this resulting communication will occur solely between the firm and the specific individual making the unsolicited request for the off-label information.
3. Representatives who provide public responses to unsolicited requests for off-label information should clearly disclose their involvement with a particular firm.
FDA recommends that a representative who responds to a public request clearly disclose in his/her public response that he/she is a particular firm’s representative and inform the requestor of the name of the firm representative or department to contact should the individual choose to follow up directly with the firm in a non-public forum for detailed information about the unsolicited request for off-label information.
4. Public responses to public unsolicited requests for off-label information described in numbers 2 and 3 should not be promotional in nature or tone.
In addition to a firm’s contact and disclosure information, a public response should include a mechanism for providing readily accessible current FDA-required labeling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labeling or, for new animal drugs, FDA-approved client information sheet). The public response should not provide any promotional information. For example, a public online response should include a direct link to the current FDA-required labeling, if any, but should not include links to any other information (e.g., product websites, product promotional materials, firm websites, third-party websites). Furthermore, the uniform resource locator (URL) or web address where viewers are directed to obtain the FDA-required labeling, if any, should not itself be promotional in tone or content (e.g., should not be www.bestcancercure.com).
If a firm responds to public unsolicited requests for off-label information, including those encountered through emerging electronic media, in the manner described above, FDA does not intend to use such responses as evidence of the firm’s intent that its product be used for an unapproved or uncleared use. Such responses also would not be expected to comply with the disclosure requirements related to promotional labeling and advertising.
What can we learn from this draft guidance? Well, the most important lesson is that if we just follow our own common sense, social media is a greenfield of opportunity to help market products but – more importantly – to help advance the public health.
If you were waiting to be led by the hand by the "emerging social media" savants at the FDA -- sorry.
The full draft guidance is worth studying and can be found here.
And Happy Hanukkah!