Civil Liberties Group Urges FDA to Stop Issuing ‘Improper’ Guidance

August 3, 2018

The New Civil Liberties Alliance (NCLA) filed a petition asking the FDA to stop using ‘improper” agency guidance to impose obligations on drugmakers and instead issue clear rules and notice-and-comment procedures.

The nonprofit civil liberties organization criticizes the agency’s “commonplace and dangerous” issuance of guidance that contains informal suggestions, interpretations and policy statements that announce the agency’s views on a topic, but does not go through public notice-and-comment procedures.

It called out the agency’s use of guidance to “bind private parties with the force of law” without making adherence mandatory. Instead, the agency “should enact clear rules that respect the limits set by the Administrative Procedure Act (APA) and the Constitution,” the NCLA said.

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