CaliforniaBefore marketing a product, pharma-ceutical and medical device companies must obtain FDA approval for that product. In order to do so, a company must demonstrate that the product is safe and effective when used for a specific purpose and the product must be labeled accordingly.

After FDA approval, however, a doctor, other medical provider, or even a consumer, may determine that the product may safely and effectively be used for a purpose that is not approved by the FDA — that is, an "off-label" use. Up to one-fifth of all prescriptions in the United States are off-label uses, with that figure rising to almost a third in some branches of medicine, such as psychiatry.

FDA_logoCompanies are forbidden, however, to promote off-label uses. In 2012 alone, Johnson & Johnson agreed to a settlement of $181,000,000 of a consumer fraud case brought by 36 states and the District of Columbia over its marketing of Risperdal. GlaxoSmithKline agreed to pay $3 billion dollars in fines, in part for promoting antidepressants and other drugs for off-label uses.

Given the potential sanctions, medical device manufacturers and pharmaceutical companies must be extremely careful in how they deal with the public regarding uses for their products.

Since at least 1982, the FDA has had a policy that permits manufacturers to respond to unsolicited requests for information. Recognizing that the huge popularity of social media is impacting communications between consumers and drug and medical device manufacturers, in December 2011, the FDA issued a long awaited draft policy clarifying its position on how drug, biologic and device manufacturers and distributors should respond to requests made through electronic or social media for off-label information. In the public comment period following the issuance of the draft guidance, pharmaceutical and medical device industry groups indicated that, although they generally support the objectives of the draft guidance, they have some concerns of certain aspects. Some critics have called certain aspects of the proposed guidelines arbitrary, overly restrictive or burdensome.

Concern over the potential restriction on productive dialogue between scientific and medical professionals has been expressed and some have indicated that the proposed guidelines would violate freedom of speech guaranteed by the First Amendment. Still others feel the draft guidance falls woefully short of providing any real guidance on how to respond to requests made through the multiple forms of social media. The public comment period is closed and the FDA is currently reviewing the feedback received through that process. As of the date of this publication, the FDA has not taken any further action to revise or adopt its guidelines. In the meantime, bloggers beware.

For a more detailed and expanded discussion of the provisions of the FDA's draft guidance, please click here or contact the authors at: Lisa Rice at This email address is being protected from spambots. You need JavaScript enabled to view it. or Katie Stricklin at This email address is being protected from spambots. You need JavaScript enabled to view it. or 714.634.2522.

Lisa M. RiceKatie A. StricklinFeel free to contact the authors with any questions:

Partner
Lisa M. Rice at
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Senior Associate
Katie A. Stricklin
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