FDA Reverses Long-Standing Policy of Not Publicly Posting Individuals' Comments

Posted 17 September 2015 | By Zachary Brennan 

FDA Reverses Long-Standing Policy of Not Publicly Posting Individuals' Comments

As part of its shift to increase transparency, the US Food and Drug Administration (FDA) said on Thursday that beginning 15 October it will publicly post individuals' comments on the regulations docket.

The new policy could potentially have an impact on lobbyists or other special interest groups submitting comments as individuals.

"In 1995, FDA explained that it routinely reviewed all comments for obvious confidential information before placing the comments in the docket (60 FR 66982), but this practice is no longer feasible given factors such as the volume of comments FDA receives and the adoption of a government-wide electronic portal system for submitting and posting comments," FDA said.


Previously, individual consumer comments were largely kept off the regulations website because of concerns about disclosing the personal information of people who may not have understood that names, addresses, and other identifying information would be publicly viewable.

As the Internet gained popularity and particularly when FDA dockets system was merged with the government-wide online portal system for submission of all public comments on government regulatory actions in 2007, FDA says the public viewability "became more obvious."

New System

Under the new system, the commenter is solely responsible for ensuring that the submitted comment does not include any confidential information, such as private medical information, a Social Security number, or confidential business information, such as a manufacturing process.

In addition, FDA will post any attachments submitted electronically, along with the state/province and country (if provided), the name of the commenter’s representative, and the category selected to identify the commenter (e.g., individual, consumer, academic, industry).

FDA adds that it expects that only in exceptional instances would a comment need to include private, personal, or confidential information. If such a case occurs and the commenter does not want to have the information be made available to the public, the comment would have to be submitted as a written/paper submission.

Federal Register

Categories: Regulatory News

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