In its ongoing efforts to address the “rapid growth of the Internet, including social media tools and other emerging technologies,” and its use by medical professionals, consumers and drug and medical device manufacturers and distributors, the Food and Drug Administration (FDA) recently issued a draft guidance proposing ways that a drug or device company may choose to respond to unsolicited requests for information regarding use of a drug or device for an “off-label” purpose without running afoul of FDA regulations.1
Before marketing a product, a drug or medical device company must demonstrate, through various processes, that the product is safe and effective when used for specific purposes and with labels and warnings that have been approved by the FDA.2 After FDA approval, however, a doctor, other medical provider, or even sometimes a patient may determine that the product may be safely and effectively used for a purpose that was not approved by the FDA—that is, an “off-label use.” Still, manufacturers and distributors are forbidden to “promote” the off-label use, no matter how well-accepted by the medical community the alternative may become.
The FDA’s draft guidance inherently recognizes the tension between the strict prohibition against promotion of off-label uses and the public benefit to be gained by manufacturers responding to inquiries regarding off-label uses of their products. It notes that there is an ever increasing likelihood that companies will encounter requests for off-label information through company-sponsored websites, discussion boards, chat rooms or other public fora. Of particular concern to the FDA is the likelihood that inquiries would be posted to the public at large, through third party sites, resulting in the dissemination to a broader audience of information (and, perhaps, misinformation) that could remain available even after scientific advances make the information obsolete.
The guidance, when complete, is designed to provide recommendations to companies by which they may respond to unsolicited “private” and “public” requests for off-label information, including through “emerging electronic media.” The FDA recognizes that companies are capable of providing “truthful” and “non-misleading” information about their own products. It also notes that companies generally will be in possession of the most “robust” and state of the art product information. Therefore, the drug or device company is in the best position to provide accurate and up to date responses to questions concerning off-label use of its products.
Notably, the draft guidance provides that if a drug or device company responds to unsolicited requests for off-label information as recommended by the FDA, the FDA does not intend to use those responses as evidence of the company’s promotion of its product for an off-label use. Thus, once the draft guidance becomes final, it may provide something like a “safe harbor” for companies that adhere to its recommendations.
Solicited Versus Unsolicited
The draft guidance does not apply to “solicited requests” for off-label information, i.e., information requests that the FDA determines have been prompted, in any way, from overt or covert promotion of an off-label use by a company. The FDA may consider responses to such “solicited requests” for off-label information as evidence that a company is promoting a drug or medical device for an off-label use. Thus, the first issue to be addressed by a company is whether a request is solicited or unsolicited.
The draft guidance contains numerous examples setting forth the differences between solicited and unsolicited requests, some of which do not intuitively fall within the FDA’s categorization. The FDA offers as an example of a “solicited” request a question that comes from someone who views a video of an off-label use that was posted on YouTube by someone not affiliated with the company, but in response to the company’s invitation to users to post videos of their product experience.
In another example, the FDA points out that if a company announces the results of a study via a microblogging service such as 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.3 The draft guidance does not apply to these or other kinds of solicited requests.
The next issue that a company must address is whether an inquiry is “private” or “public.” The draft guidance provides different paths for each. However, in either circumstance, companies may respond to unsolicited requests for information about FDA-regulated medical products so long as they provide truthful, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request, even if doing so requires a company to provide information on unapproved indications or conditions of use.
It seems clear that the FDA is more comfortable when companies respond to non-public unsolicited requests for off-label information through private one-on-one communications. As examples, individuals might send private requests for information on an off-label use to a company through mail, e-mail, telephone or a company-controlled website that enables individuals to conduct private communication with the company.
The FDA provides a number of recommendations for companies faced with this situation. It states that:
1. Information should be provided only to the individual making the request as a private, one-on-one communication;
2. Information should answer only the specific question or questions asked;
3. Information should be truthful, non-misleading, accurate and balanced;
4. Information should be scientific in nature;
5. Responses should be generated by medical or scientific personnel independent from sales or marketing departments; and
6. Information should be accompanied by a copy of the FDA-required labeling, if any, for the product; a complete list of references for all of the information disseminated in the response; and “prominent” statements (i) notifying the recipient that the FDA has not approved the product as safe and effective for the use addressed in the materials provided, (ii) disclosing the indication or indications for which the FDA has approved the product, and (iii) providing all important safety information including, if applicable, any boxed warning for the product.
The FDA also recommends that companies maintain records regarding the request for information, including the name, address and affiliation of the requestor; the information provided to the requestor; and any follow-up inquiries or questions from the requestor.
Social Media Requests
Of apparent greater concern are requests that are made publicly. The draft guidance has a lengthy section dealing specifically with requests for off-label information encountered through what the FDA characterizes as “emerging electronic media,” such as product websites, discussion boards, chat rooms, company-controlled electronic forums, and third-party sites over which companies do not maintain control.
In these situations, the FDA apparently is concerned that companies might post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating off-label use information to individuals who have not requested that information. The FDA also is concerned about the “enduring nature” of detailed public online responses to off-label questions because specific information may become outdated. Accordingly, the draft guidance contains a number of recommendations that essentially enables a company to respond to a public request privately.
First, the FDA recommends that a company respond only when the request pertains specifically to its own named product (and is not either generic or solely about a competitor’s product). Thus, for example, if an individual poses a non-specific question such as “What drug can be used for Condition Y” in a public communication thread and a pharmaceutical company manufactures or distributes a drug that is not FDA-approved or cleared for that condition, the company should not respond to the request because the question is not specific to its drug.
Even when an unsolicited request for off-label information is posed as to a specific drug or device, the FDA also recommends that a company’s public response be limited and should not include any off-label information.
The response should convey that the question pertains to an off-label use and state that individuals can contact specifically identified medical/scientific representatives of the company or its medical affairs department for more information. Contact information for the specific individuals should be provided so that individuals can follow up independently with the company to obtain specific information about the off-label use of the product through a non-public, one-on-one communication. The company representatives who provide public responses should clearly disclose their involvement with their company. In addition, a public response should include a mechanism for providing readily accessible current FDA-required labeling, if any, for the product (such as an FDA-approved package insert, an FDA-approved patient labeling or, for new animal drugs, an FDA-approved client information sheet).
Moreover, a 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, company websites or 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; the example provided by the FDA in the draft guidance is that it “should not be www.bestcancercure.com.”
When and if any individual follow up occurs as a result of information publicly posted, the FDA recommends that companies thereafter proceed as if the request was privately generated in the first instance and follow the steps set forth above. Nevertheless, regardless of the fact that the unsolicited off-label question may have originated in a public forum, a company should not make its detailed response with off-label information publicly available within the same forum. Instead the company’s detailed response should be directed solely to the individual requestor through the means of communication, such as an e-mail address, that the individual provides.
The FDA’s draft guidance does not seem to necessarily impose excessive restrictions on social media use by companies and, in fact, may provide welcome recommendations. Even companies that are not in the drug and medical device industry but that use social media for marketing purposes should pay close attention to the draft guidance as it becomes finalized, as it may provide an excellent template for best practices depending on the nature of the industry involved. Comments are due on this draft guidance by March 29, with the draft guidance likely to be finalized soon thereafter. Once that happens, drug and device companies will need to ensure that their marketing, sales and science staffs, as well as personnel in charge of recordkeeping functions, are fully familiar with the FDA’s recommendations and the new standard.
Shari Claire Lewis is a partner at Rivkin Radler and can be reached at firstname.lastname@example.org.
1. See Draft, “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm285145.pdf.
2. Id. at 2.
3. It also should be noted that footnote 7 of the draft guidance points out that some activities in the examples the FDA cites as soliciting requests for off-label information “may themselves give rise to specific regulatory violations,” although the draft guidance itself does not indicate what those violations might be.