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January 2012

Daily Journal Quotes Kai Peters on FDA's Guidance and Federal Register Notice Regarding Off-Label Marketing

A January 23rd article from the Daily Journal titled "Drugmakers Look to FDA for Guidance on Off-Label Marketing" quotes Kai Peters, a Partner in the Pharmaceutical and Medical Device and Life Sciences practices at the San Francisco office of Gordon & Rees. The article discusses how pharmaceutical companies continue to seek clarity from the FDA on off-label marketing in the face of heightened and costly federal prosecution against the illegal promotion of unapproved uses of drugs. To avoid billions of dollars in civil and criminal penalties, seven major pharmaceutical companies filed a petition with the FDA on off-label marketing.

As a result, the FDA recently published a Federal Register notice on scientific discussions of off-label drug and device uses, asking for industry input by March 27th. The notice focuses on exploring the parameters of "scientific exchange," in which companies can engage, and impermissible off-label promotion. The FDA also issued a Draft Guidance on how to respond to unsolicited requests for off-label information about prescription drugs and devices, asking for industry input by March 26th. The guidance explores the parameters of permissible communications regarding off-label uses, including with respect to Internet chat rooms, on social media, and on websites.

Commenting on these two actions, Kai Peters said, "When I look at both the draft guidance and the Federal Register notice, I would say that neither one signals to me any kind of departure from the FDA's positions."

Mr. Peters continued, "I don't think the FDA is signaling a retreat or modification of its views on off-label communication. Both [documents] indicate they want to regulate it and restrict it and make manufacturers very wary of engaging in off-label communications."



Kai Peters