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Advisory Opinion Process

One group, representing several prescription drug manufacturers, requested that FDA create an advisory opinion process for “timely binding advice in response to a specific request on proposed promotional and scientific exchange practices.”  The group stated that the availability of an advisory opinion process at FDA would encourage greater industry compliance with FDA laws and regulations while providing improved communication to the public about important health information.  It also noted that other federal agencies have established an advisory opinion process, including, the Office of Inspector General (OIG) at the Department of Health and Human Services (HHS), the Centers for Medicare and Medicaid Services (CMS), and the Federal Trade Commission (FTC).

FDA currently has a process in place for companies to receive advisory comments on specific promotional pieces for drug and biological products before disseminating those pieces.   Although these comments are not binding, if FDA subsequently changes its position on a promotional piece, the agency is required to provide notice to the submitter and a reasonable amount of time to correct the promotional piece before FDA will take enforcement action.

The Task Force concluded that the feedback FDA currently provides to pharmaceutical companies on the content of specific promotional pieces is within the agency’s expertise and contributes to FDA’s mission to protect and promote the public health.  The request for FDA to issue binding advisory opinions may place inappropriate restrictions on FDA’s ability to respond to emerging issues to best protect and promote the public health.

The Task Force also considered whether a binding advisory opinion process for food labeling would aid FDA in its mission to protect and promote the public health.  As stated above, issuance of binding advisory opinion may limit the agency’s flexibility to address emerging public health issues and to implement its statutory responsibilities.  In addition, requestors may fail to provide, or subsequently change, claims or product formulations that might render the labeling at issue unlawful.  But the company may mistakenly believe it can continue to rely on a favorable advisory opinion.  This may have negative consequences for public health.

CFSAN’s Office of Nutrition Labeling and Dietary Supplements (ONLDS) often responds to questions from food companies about labeling and promotional matters, such as the proper nomenclature for a food ingredient or “front-of-pack” labeling claims.  In some instances, CFSAN also uses guidance to communicate with industry about such matters.

The Task Force is not recommending changes to current practice.  

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Agency Interactions with Manufacturer Regarding Public Communication about Emerging Safety Issues with a Manufacturer’s Product 

Comments requested that FDA communicate with companies in advance of disclosing safety information about their products publicly.  Some comments suggested that FDA engage with the manufacturer of the product at least 48 to 72 hours prior to communicating emerging safety issues to the public; another comment suggested at least 72 to 96 hours notice.  These comments noted that prior notice would allow time for companies to work with FDA to develop complimentary communications to the public and healthcare providers about the issue and allow the company time to prepare for questions from doctors, patients, and the media.

One comment from a trade association also requested that FDA share information with sponsors about the methods FDA used to conclude that there may be a safety concern with a product.

Discussions with industry are generally needed in advance of communicating with the public in order for FDA to gather additional information to further understand the potential safety issue.  Those discussions provide notice to the company that FDA is exploring safety concerns with one of its products.

When appropriate, FDA works with the relevant manufacturer(s) regarding emerging safety information about its product or class of products.  FDA may also notify the manufacturer and solicit input from the manufacturer prior to disclosing information to the public, for example, to confirm the accuracy of factual information or to assure consistent and non-confusing messages are communicated to the public.  CDER aims to notify the relevant sponsor that emerging drug safety information about its drug will be posted on the FDA Web site at least 24 hours before the public communication is issued.   However, when necessary to protect public health, FDA may notify the public without first informing the manufacturer.  As a result of the need for the agency to respond based on the specific facts at hand, the Task Force is not recommending any changes to current practice.

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