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FDA Issues Draft Guidance on Responding to Unsolicited Requests for Off-Label Information

Wendy Blackburn

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Two years ago, in November 2009, FDA held a public hearing to address five critical questions related to the use of the Internet and social media in the promotion of FDA-regulated medical products. Then one year ago, FDA outlined which areas the agency would focus on first. Responding to unsolicited requests was at the top of that list. On Dec. 27, 2011, FDA made good on that promise. While many pharma marketers were taking holiday vacation time, FDA quietly issued draft guidance addressing how pharmaceutical companies may respond to unsolicited requests for off-label information.

Why Is This Important?

The guidance applies to prescription drugs (including biological products), medical devices, and animal health products. Much of the guidance addresses how manufacturers should respond to questions posed in public online forums. The guidance also mentions a number of "emerging electronic media" such as Twitter, YouTube, and discussion boards that we haven’t seen FDA address directly in the past.

Elements of the guidance address some of the questions raised at the November 2009 hearing. While still in draft form, the document provides some important insights into the direction and mindset of FDA’s view of the use of electronic media by pharmaceutical and medical device companies.

The full text of the guidance, Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices, can be found online on the FDA website. Those interested can provide suggestions and comments to FDA within 90 days.

Intouch is providing a full explanation of the guidance and our thoughts on what this means to the pharma industry as a downloadable PDF. But, we also wanted to provide some of the highlights below.

How Can Pharma and Device Companies Respond?

FDA acknowledges that companies can, if they choose to, respond to unsolicited requests for information about FDA-regulated products by providing "truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request." This applies, FDA notes, "even if responding to the request requires a firm to provide information on unapproved indications or conditions of use." If these rules are followed, responses don’t need to meet regulatory requirements for promotional labeling or advertising.

Two key points to note up front:

  1. The company has the choice to respond to unsolicited requests or not.
  2. If the company chooses to respond, the actual response can only be provided in a private, one-on-one communication. This applies to questions posed in both a private and public setting.

Responding to NON-PUBLIC (Private) Unsolicited Requests Directed to the Pharma/Med Device Firm

  1. Be Direct. Respond only to the person that asked the question.
  2. Be Specific. Respond only to the specific question asked. If the question is broad or unclear, the company should work to clarify and narrow down the question in order to tailor the response. If there are specific risks associated with other conditions that may be relevant to the off-label use mentioned, the firm should provide that information.
  3. Be Accurate and Balanced. Respond only with truthful, non-misleading, accurate, and balanced information. If an article that was published was called into question, the company should disseminate both the original and the opposing article. Responses should include complete copies of literature and not just summaries. The response can include unpublished data if appropriate, but peer-reviewed journals and other independent articles are preferred. Journal reprints should only be provided from journals that adhere to a policy of full disclosure of conflict of interest or bias.
  4. Science vs. Promotion. Information provided should be scientific in nature and should not be promotional or distributed alongside material that is promotional.
  5. Deploy Appropriate Responders. Questions should be referred to and responses should be generated from trained medical/scientific staff independent from sales or marketing departments.
  6. Provide Accompanying Materials. When a company responds to a request, it should include appropriate FDA-required labeling (PI, medication guide, and/or client information sheet), a complete list of references for all information disseminated, several "prominent statements," including, "FDA has not approved this product as safe/effective for the use discussed," disclosure of the FDA-approved indication and all important safety information, including any boxed warnings.
  7. Keep Records. The nature of the request, including contact information and affiliation, the information that was provided and any follow-up inquiries should all be retained.

Responding to PUBLIC Unsolicited Requests Directed to Users At Large

One critical point of this section is that, essentially, responses to public requests should be made private. The conversation should be directed to a one-on-one setting so that it takes place solely between the firm and the requestor. FDA’s stance is, if a reply is posted publicly, it is being communicated to individuals that didn’t ask the specific question and may therefore be considered off-label promotion. FDA also recognizes that things tend to live forever on the Web and responses can become outdated as new information becomes available. When responding to public unsolicited requests, companies should:

  1. ID Appropriate Requests. Companies should only respond to requests if they pertain to that company’s own named product.
  2. Limit the Info. The public response should be limited to providing only the firm’s medical/scientific staff contact information, conveying the question pertains to an unapproved use.
  3. Provide Disclosure. Company representatives responding publicly to inquiries should clearly disclose that they are a representative of the company, and direct them to the appropriate contact.
  4. Avoid Promotion. The public response that redirects the person to a one-on-one exchange should provide a link to FDA labeling but should not provide links to anything promotional in nature such as a website.

Reading Between the Lines: The Story Behind the Story

There are a lot of things this document doesn’t do — namely, it is not the clear-cut social media guidance that industry has desperately been seeking. But we are excited to see FDA acknowledge the existence of — and use as examples — electronic media such as Twitter, YouTube, online discussion forums, email, and the like. And, if one looks closely, the document does provide some insight into FDA’s thinking. It may not be social media guidance, but there are some important things to note from a social media perspective:

  1. Hooray for Clarity. While no doubt some questions remain, the direction is fairly specific in terms of not only what type of information can be used in responses, but also what information should and shouldn’t be provided in both public and private forums. FDA also provides an example where the use of a link to PI is appropriate. We applaud any communication from FDA that is clear (if not concise) on direction.
  2. Time to Revisit Social Media Workflows. The guidance, though draft, provides enough information at this point to revisit existing social media workflows that address how to respond to off-label inquiries or comments. In most cases, off-label inquiries are already routed through the appropriate channels, but FDA now lays out guidelines on how to publicly direct
  3. Offline-to-Online SOPs. Since companies have been responding in a similar manner to requests for off-label information already, the document essentially acknowledges that — as many have done with social media — adapting offline processes for online application is the right way to go.
  4. The Unsocial FDA. Those familiar with social media conversation norms will groan at the prospect of providing a response in a public forum in the manner in which FDA suggests. We should further assess how companies can best communicate in the manner and tone in which FDA requires without sounding like robots. Consumers won’t necessarily always welcome a terse response that redirects them to a different channel. Pharma and med device companies should work hard to craft responses that meet the requirements but still sound human.
  5. Social Media Is Still an Option. FDA did not state that a company cannot respond to requests made via the Internet or social media. Indeed, the agency acknowledged that, if done correctly, pharmaceutical companies could be in a position to further the interest of public health by doing so.
  6. Policing the Internet. FDA also did not state that companies are REQUIRED to respond to off-label inquiries; it’s the company’s choice. Pharma’s responsibility for policing the entire Internet was a hot topic at the 2009 hearings. This document gives us a peek into FDA’s position on that topic.

All in all, FDA is recognizing the sea change that the Internet has provided in enabling the exchange of information and the empowerment of patients. And perhaps this will indeed turn out to be the first in a series of promised guidance to come out of the 2009 hearings. We will continue to monitor the topic and will keep you posted as new information emerges.

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