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FDA Guidance on Off-Label Unsolicited Requests

Posted by | 4:45pm on Wednesday, January 4, 2012
Hardcover book gutter and pages

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 

While I was enjoying the holidays by sleeping in, sipping wine and spending time with family, the FDA quietly released “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.”

Ad Age called the document “social media ‘guidelines’” apparently because it mentions Twitter and YouTube in examples. While it isn’t true social media guidance, former FDA official Peter Pitts provides insights to be gleaned from reading between the lines. His big one: “Pharma, guide thyself.”

What I found most interesting in the document is the FDA’s acknowledgment 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.”

What the document does say
Unsolicited off-label requests are “initiated by persons or entities that are completely independent of the relevant firm.” The FDA details two types of unsolicited requests:

  1. Non-public unsolicited request: directed privately to a firm using a one-on-one communication approach.
  2. Public unsolicited request: made in a public forum, whether directed to a firm specifically or to a forum at large. A question posted on a firm-controlled website or a third-party discussion forum was provided as an example.

Solicited off-label requests are those prompted in any way by a manufacturer or its representatives. This is where the agency uses Twitter and YouTube as two of the examples of what a solicited off-label request might look like. Solicited off-label requests are not compliant with existing FDA regulations.

The FDA’s long-standing approach to unsolicited requests is that they can be responded to by providing “truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request.”

What’s new: a public response including “emerging electronic media”
The agency provides recommendations for 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”: the firm should reply only when the question is specifically about its own named product; the responding representative should disclose their relationship to the firm; and the response should not be promotional in nature or tone.

The guidance is clear that a company should publicly reply to a public unsolicited request with direction that the question be discussed in private. The FDA says the reply should identify the question as off-label and provide contact information for a medical or scientific representative so that the person can follow-up through private, individual communication. It’s important to note that the guidance specifies that the response should be from medical or scientific reps, not sales and marketing.

The document also says “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).” This is surprising, since brand websites should be the most comprehensive source of on-label information.

Why a public response that ends up with a private answer? The FDA reasons that a public reply will be available to a wide audience, including more than just the person asking the original question. The information may also be available for an indefinite time period and become out-of-date.

The impact
Agencies who perform social media monitoring on behalf of their biopharma and medical device clients should understand this guidance. If a company decides to implement a response policy, relevant queries can be identified via online listening. A process could be put in place to funnel appropriate questions to medical/scientific reps for a response.

What do you think of the guidance? Check out the Astra Zeneca point of view on their blog.

(Image courtesy of Horia Varlan on Flickr.)

About Eileen O'Brien

Eileen has more than 16 years of digital healthcare marketing experience. She is an opinion leader on social media and biopharma, and has been invited to speak at industry conferences and quoted in publications.

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