CaliforniaBefore marketing a product, pharmaceutical and medical device companies must demonstrate that the product is safe and effective when used for a specific purpose and with labels and warnings that have been approved by the FDA.  After FDA approval, however, a doctor, other medical provider, or even a consumer may determine that the product may be safely and effectively used for a purpose that was not approved by the FDA - that is, an "off-label" use.  Up to one-fifth of all prescriptions in the U.S. are off-label uses, rising to almost a third in some branches of medicine like psychiatry.  Still, companies are forbidden to promote the off-label use, no matter how well-accepted the alternative use may become.

Background and FDA Draft Guidance

Since at least 1982, the FDA's policy has permitted manufacturers to respond to unsolicited requests for information.  In November 2009, the FDA held a public hearing on its intention to issue draft guidance regarding its policies on the promotion of products on the internet and through the use of social media.  In December 2011, the FDA issued a draft guidance which does not change or otherwise effect existing regulations.  Rather, the draft guidance is intended to clarify existing policies on unsolicited requests for off-label information and to provide guidance on how drug, biologics or device manufacturers and distributors (collectively "Companies") should respond to requests made through electronic or social media for off-label information.

FDA_logoThe FDA's draft guidance recognizes the tension between the strict prohibition against promotion of off-label uses and the public benefit to be gained by Companies responding to inquiries regarding off-label uses of their products.  Specifically, the draft guidance notes that there is an increasing likelihood that Companies will encounter requests for off-label information through company-sponsored websites, discussion boards, chat rooms, or other forms of social media.  Of particular concern to the FDA is the likelihood that inquiries would be posted to the public through third party sites, resulting in the dissemination of information to a broad audience that could remain available even after scientific advances make the information obsolete.  Thus, the draft guidance is designed to provide recommendations to Companies by which they may respond to unsolicited "private" and "public" requests for off-label information through electronic media.  (An unsolicited request is defined by the FDA as one not initiated in any form by the Companies.)

Private Requests

In the event of a non-public unsolicited request for off-label information, i.e., an individual sending a private request for information regarding an off-label use to Companies through mail, email, telephone or a company-controlled website, the draft guidance provides a number of recommendations and states: 

1.  Responsive information should be limited to the requestor and treated as private, one-on-one communication;

2.  Information should be limited to the scope of the initial question;

3.  Information should be truthful, non-misleading, accurate, and balanced;

4.  Information should be scientific in nature;

5.  Responses should be generated by medical or scientific personnel independent from sales or marketing departments;

6.  Responsive information should be accompanied by several documents, including a statement notifying the recipient that FDA has not approved the product for the specific off-label use; and

7.  Companies should maintain required records, including any follow-up questions from the requestor.

Public Requests

Of apparent greater concern to the FDA are requests that are made publicly.  The draft guidance contains a lengthy section dealing specifically with requests for off-label information encountered through what the FDA characterizes as "emerging electronic media," such as product websites, discussion boards, chat rooms, company controlled electronic forums, and third party sites over which companies do not maintain control.  Accordingly, the draft guidance contains a number of recommendations that essentially enables Companies to respond to a public request privately.  It states: 

1.  Companies should respond only to a request about its own named product and is not solely about a competitor's product;

2.  Companies' response should be limited to providing its contact information and should not include any off-label information;

3.  The representative who provides public responses should clearly disclose his/her specific involvement with the Companies; and

4.  Responses should not be promotional in nature or tone.

Industry Response

In response to the draft guidance, drug and medical device industry groups have indicated that although they generally support the objectives of the draft guidance, they have some concerns with certain aspects.  Specifically, critics suggest that certain recommendations are arbitrary, overly restrictive, burdensome, and would not serve the best interests of the public health or further the important goals of scientific exchange.  There is concern that it would inhibit an open and productive dialogue between scientific and medical professionals and have a chilling effect on scientific speech, inconsistent with the protections afforded by the First Amendment.  Various industry groups would also like to see the FDA provide more comprehensive guidance on the use of social media.  The draft guidance includes examples related to the use of social media, but certain groups feel this falls short and would like a more comprehensive document specifically addressing social media.

Lisa-Rice-headshot-web-nameKatie-S-headshot-web-name-Feel free to contact the authors with any questions:

Lisa M. Rice at
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Senior Associate
Katie A. Stricklin
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Or any WFBM attorney with whom you are working.