Industry Comments on Draft FDA Guidance

Several leading drug manufacturers have worked to shed light on serious issues with the social media guidance issued earlier this year by the U.S. Food and Drug Administration.

Readers may recall the draft guidance was intended to describe FDA’s current thinking about how manufacturers and distributors can fulfill regulatory requirements for postmarketing submissions
of interactive promotional media for their FDA-approved products.  A number of industry members have submitted formal comments

PhRMA and its member companies highlighted two fundamental concerns with the Draft Guidance. First, the Draft Guidance assumes that a biopharmaceutical manufacturer can be held accountable for content written by third-parties on third-party web sites if the company merely somehow "influences" the third-party. This premise is overbroad and is inconsistent with the FDCA. Put simply, third-party statements not caused or controlled by a manufacturer do not fall within the statutory or regulatory scope of FDA‘s authority to regulate promotional labeling or advertising. Second, the Draft Guidance erroneously assumes that all manufacturer statements about prescription medicines on social media constitute promotional labeling or advertising. This expansive interpretation of labeling and advertising adopted in the Draft Guidance could chill truthful and non-misleading communication protected by the First Amendment. Thus, it is critical that FDA address these fundamental issues in the Final Guidance.

WLF echoed the latter concern. noting serious problems with the Draft Guidance at Section IV (entitled, "Factors Considered in Determining Postmarket Submission Requirements for Interactive Promotional Media"). The Draft Guidance's basic premise seems to be that everything a manufacturer posts on-line: (1) qualifies as "promotional" material; (2) falls within FDA's statutory purview; and (3) is not protected from FDA regulation by the First Amendment. Those premises are 
demonstrably incorrect. Accordingly, agency policy in this area ought to begin with guidance
regarding where FDA draws the line between speech that it is and is not permitted to regulate.
The Draft Guidance brushes aside such concerns and seems to indicate that FDA intends to regulate everything that a manufacturer says regarding its products on social media sites.

It will be interesting to see how the FDA reacts to these valid comments.

 

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