Drugs

Changes Sought in FDA Misinformation Guidance

David McFarland

— 2 min read
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The Medical Information Working Group (MIWG) says it has concerns about a revised FDA question-and-answer draft guidance on addressing misinformation about medical devices and prescription drugs. In its comment, the MIWG says that despite improvements made in the current revision, it still has concerns about the guidance’s scope and its overall approach to regulating manufacturer communications. It makes these points for FDA to consider:

  • the enforcement policy outlined in the revised draft is overly narrow and incommensurate with the extent of misinformation that exists online; and
  • the revised draft continues an approach to regulating communications that is piecemeal and incomplete, does not align with FDA’s statutory authority, and stifles speech.

“MIWG strongly supports efforts to combat misinformation regarding medical products to promote the appropriate and safe and effective use of medical products and to improve patient care,” the group concludes. “While we commend FDA for its focus on addressing medical misinformation, we believe that the proliferation of misinformation requires a more robust, comprehensive, and flexible response than the revised draft provides. We respectfully request that FDA refrain from issuing any further policy that exacerbates the lack of a cohesive framework, and we implore FDA to redouble its efforts to establish a clear regulatory framework for manufacturer communications based on broad, cohesive principles that adhere to constitutional and statutory mandates.”

In its response, Pharmaceutical Research and Manufacturers of America says it supports the guidance’s overarching goals and those portions of the draft that provide a flexible and pragmatic approach for countering misinformation. It says the agency should revise the draft to:

  • remove any reference to “enforcement policy” as the basis or framework for FDA’s recommendations;
  • broaden the scope of medical products and uses covered;
  • permit firms to respond to opinions, value judgments, or personal experiences that are contrary to the approved labeling and associated evidence supporting approval for a treatment;
  • permit “tailored responsive communications” to correct misinformation beyond Internet-based communications;
  • reinforce that the term “independent third party” may encompass newer categories of commercial entities that have expanded in recent years to market treatments; and
  • provide additional flexibility for how recommended disclosures are included in “tailored response communications.’”

Finally, AdvaMed says the medtech industry “is committed to truthful, accurate, and non-misleading information about [medical] devices, and we believe this guidance reflects an important enforcement policy to support companies who may choose to proactively address information amidst an increasingly digital world where consumers are turning to the Internet for health and medical information.” The association submits line-by-line specific comments.

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