Court Tosses Part of Exclusivity Suit Against FDA, Holds Off on Related Issue

A federal district court threw out part of a lawsuit Tuesday against the FDA over its handling of an exclusivity decision.

Judge Rudolph Contreras of the U.S. District Court for the District of Columbia granted the FDA partial summary judgment in a lawsuit brought by Ferring Pharmaceuticals.

The case centers on Ferring’s efforts to obtain five years of marketing exclusivity for its bowel prep drug Prepopik under the FDCA’s allowance for new chemical entities. Ferring sought the designation in 2012 because one of Prepopik’s three active ingredients was new, but the agency refused because it interprets the law to apply only to finished drugs and not their components.

Ferring petitioned the FDA three times to reconsider its standard, arguing that the language of the statute and the agency’s corresponding regulations were ambiguous. The agency denied the petitions but eventually issued draft guidance fulfilling the company’s request by reinterpreting the statute to apply to new ingredients in drugs, rather than new drugs.

However, this action didn’t help Ferring because the FDA refused to apply the guidance retroactively, preventing Prepopik from qualifying for the full five years of exclusivity. Ferring filed suit, contending that the agency’s approach violated the Administrative Procedures Act by operating outside the plain language of the statute and in making arbitrary or capricious decisions.

With his ruling, Contreras determined that the agency’s refusal to grant marketing exclusivity for Prepopik was based on a reasonable interpretation of its statutory authority. This held true even after the agency reversed its interpretation of the statute based on multiple petitions from Ferring.

However, Contreras delayed ruling on whether the agency’s updated interpretation of the statute should have been retroactively applied to Ferring, saying neither side furnished sufficient information for the court to render a decision. The judge asked both sides to refile their arguments to fully address the retroactivity issue.

The court also rejected Ferring’s request for summary judgment in the case, contending that the company’s arguments against the FDA’s interpretation of the statute or claims that it exceeded its statutory authority were not persuasive.
Representatives of Ferring did not respond to a request for comment on the decision.

Read the order here: www.fdanews.com/03-17-16-DistrictCourtOpinion.pdf. — Cameron Ayers

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