Franck’s Lab Ruling Casts Doubt on FDA’s Use of Guidance Documents, Say HP&M Attorneys

December 22, 2011

In a new Legal Backgrounder published by the Washington Legal Foundation, Hyman, Phelps & McNamara, P.C.’s Karla L. Palmer and Jeffrey N. Gibbs write that a recent Florida federal district court ruling in United States v. Franck’s Lab, Inc., if upheld on appeal, will have implications that extend broadly to other areas of FDA law, particularly as it relates to FDA’s increasing use of guidance documents to expand regulatory requirements. 

As we previously reported, the U.S. District Court for the Middle District of Florida (Ocala Division) ruled in September 2011 that FDA did not have authority to enjoin the “long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non-food producing animal by compounding from bulk substances.”  The court reached its decision after wading through the various guidance documents FDA had issued through the years laying out the Agency’s criteria for when it would decline to exercise “enforcement discretion,” and instead initiate enforcement action against a compounding pharmacy.  In early November, the government appealed that decision to the U.S. Court of Appeals for the Eleventh Circuit.

Ms. Palmer and Mr. Gibbs write that if the Eleventh Circuit upholds the district court decision, the decision “will be invoked by interested parties seeking to constrain FDA’s use of non-binding guidance documents to define prohibitions against which FDA may take enforcement action or impose new requirements on applicants, and to attack FDA assertions that it is entitled to Chevron deference.”  Although FDA’s desire to use guidance in lieu of rulemaking is understandable, say the authors, as guidance documents take less work to promulgate, go through less review, and can be revised more readily, “ease of use does not excuse FDA from the need to comply with the Administrative Procedure Act.”