The FDA has finally dipped its toes into the digital waters by providing its first draft guidance that implicates social media. Entitled, “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” it advances the dos and don’ts on how to handle unsolicited requests for drug or device information that concerns unapproved uses. Written in fairly straight-forward terms, the guidance specifies what constitutes requests that are unsolicited from those that are, and the FDA provides concrete examples for helpful illustration. Throughout the guidance, it is clear that the FDA has thought seriously about the consequences of its advisories upon the pharmaceutical industry and has also secured the public’s safety by requiring answers that are truthful and balanced.
While many in the social media and healthcare community had hoped for grander offerings from the FDA, they have tackled a clear danger. Besides, any action on social media for the FDA is a good thing, as much ambiguity still exists on what constitutes proper behavior by drug companies online. A bit of housekeeping for those unfamiliar with the FDA’s jargon: the term “off-label” refers to uses of a drug or medical device that is not sanctioned by the FDA. In the normal course of drug and medical device development, once the FDA approves such items, they are approved for a particular indication. So if a drug is approved to treat headaches, for example, that means it is only approved for that use. Any other purpose would have to be separately studied through rigorous clinical trials to obtain approval.
Online chatter regarding drugs and devices sometimes includes references to uses that lie outside the official FDA sanction. Whether on a blog or a medical site, there are plenty of places to read someone’s opinion about how a given drug or device has helped them with some medical ailment which may not be a use listed on its official label. While doctors commonly prescribe approved drugs for uses other than their intended original purpose, no drug company can promote off-label uses. The risk of someone using a drug or device for an off-label purpose discovered online could present a dangerous situation and has drawn the FDA’s attention to create its guidance. When a person requests information about an off-label use of a given drug or device, the manufacturer now has a set of directions on how to handle that matter.
When does the guidance kick into play? If a person privately requests information about a drug or device directly from the manufacturer or if the request is publicly announced (online or at a public setting), then an “unsolicited request” has been made. The FDA broadly construes a public-generated request to include those, “directed to a firm specifically or posed to users of a discussion forum at large.” This grants pharmaceutical organizations a wide berth to weigh in even if the requester was chatting to others on an open forum.
By the way, if pharma companies receive solicited requests, then the companies are obligated to respond—this has always been the case. This includes situations where the drug/device company has invited patients to post YouTube videos on how they used a drug or device, which in turn triggered requests for information about off-label use or resulted in videos showcasing off-label use. The same is true if a drug company posts clinical study results that suggest off-label use of its product as being safe and effective which spurs questions from the public regarding off-label uses. Basically, if the drug/device company incites or provokes questions about off-label use, then it must respond. In contrast, the new guidance pertains to unsolicited requests and gives drug/device manufacturers direction on handling these situations if they choose to respond.
The FDA has always granted drug makers the power to provide, “truthful, balanced, non-misleading, non-promotional, scientific or medical information that is responsive to the specific request,” concerning their products. Moreover, no matter how the request was made, publicly or privately, when pharmaceutical companies choose to respond to unsolicited requests, those responses must be made privately to the inquiring individual.
The FDA advises that when responding to an unsolicited private request, the pharmaceutical company should make sure the communication be privately sent to the person making the request and that it answer only the questions posed. So, if someone asked about an off-label use of product “x”, then the company should answer that without elaborating on other off-label topics regarding the product. The FDA goes so far as to encourage a narrower definition of the question even if it is broadly phrased. However, the FDA makes an exception when it comes to the risks posed by the product. So, if a given product poses known or suspected risks that bear relevance to the person’s question, they must divulge that information. This is common sense that keeps the public safe and the drug companies honest.
The FDA requires that the, “Information distributed in response to an unsolicited request should be truthful, non-misleading, accurate, and balanced.” That means providing information that casts doubt on the safety and efficacy of an off-label use. Providing medical texts and scientific peer-reviewed journal reprints are advised so reliable information gets in the hands of the person seeking valid answers. The agency further instructs pharma companies to use a scientific tone and to avoid gimmicky promotional messaging. To ensure the last point is credibly undertaken, the FDA has advised that the responses, “should be generated by medical or scientific personnel independent from sales or marketing departments.” This is a brilliant stroke by the agency, though this could result in highly academic communications that are too obtuse to be understood by the lay public. Nevertheless, this is a move in the right direction that shields the public from slick marketing.
As part of any formal response, the FDA encourages the provision of the official label, a prominent statement that the off-label use is not approved, a clear statement for which uses the product is approved, safety information, and a list of references of all the information provided. Finally, the FDA advises that all responses be documented by noting the nature of the request, the contact information of the person seeking the information, what information was provided, and any follow-up inquiries or questions from the requester.
When a pharma company encounters questions regarding off-label use of its product online (as on public website or social media forum) it can choose to respond in the following manner:
- It can provide the firm’s contact information, inviting the requester to seek more information from their medical advisor, but cannot provide off-label information in that same public forum.
- The contact information provided to the requester must be specific to that medical or scientific personnel (e.g. e-mail address, telephone number, facsimile).
- Recordkeeping requirements described above also apply here.
- When a pharmaceutical company chooses to respond to an online episode of an “unsolicited request,” that company representative must identify himself when providing the contact information.
- These responses cannot be promotional in nature.
- Direct links to the current FDA-required labeling should be provided, but no other links (e.g. product websites). The sites where FDA-required labeling is available cannot be promotional either, so you can’t have a URL that reads “www.TheCureForCancer.com”)
Taken altogether, the FDA has given a clearly defined set of actions on how to handle unsolicited off-label questions. This draft guidance was issued on December 27, 2011, so the public has 90 days within which to respond provide feedback to the FDA. So for now, this is merely suggestive, not mandatory, but has provided a transparent view of the agency’s direction.