FDA offers draft guidance on unsolicited requests for off-label drug information

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Pharmaceutical CommercePharmaceutical Commerce - January/February 2012

The basic principle is: say as little as possible in public—and document what is said privately

At the end of December, FDA’s Office of Prescription Drug Products (OPDP) issued draft guidance on off-label communications, with a particular emphasis on when such requests might arise in digital forums like social media sites. However, as Lori Leskin, a partner at the New York law firm Kaye Scholer LLP, specializing in product liability, points out, “This is not the broad-based guidance on social media that everyone in the pharma industry is waiting for—but it does address a small piece of it.”

FDA’s guidance (which is up for a 90-day comment period) envisions two scenarios: public and “non-public” unsolicited requests. (“Solicited” requests, by longstanding precedent, are those generated by a manufacturer, such as a public presentation—and are generally tightly restricted if not outright forbidden.) For non-public requests, manufacturers are instructed generally to provide only the directly relevant scientific data or publications; to restrict input from sales & marketing departments in responding; but to respond more broadly when providing information on potential risks or side effects. Precise documentation on who is making the request should be recorded.

For public unsolicited requests, while OPDP notes 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 a firm’s products … especially since other responders may not provide or have access to the most accurate and up-to-date medical product information,” it still recommends that manufacturers do nothing more than to provide contact information for the firm, and then handle any subsequent communications the same way a non-public request would be.

Kaye Scholer’s Leskin points out that not only is this “not much of a change” from prior, pre-Internet situations, and that merely acknowledging publicly that there is information available on off-label use could open up a company to liability litigation; so the upshot of this guidance could be simply to keep industry muzzled when it comes to public forums. Moreover, no distinction is made between forums of healthcare practitioners and those of the general public; whether a more open discussion could occur at a physician-only site is an “unanswered question.”

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