Wednesday, May 01, 2019

The CAFC contemplates the intersection of the ITC and the FDA/FDCA

From the decision

After Amarin filed its complaint, the FDA submitted a
letter urging the Commission not to institute an investigation and instead to dismiss Amarin’s complaint. J.A. 627–
37. In the FDA’s view, the FDCA prohibits private enforcement actions, including unfair trade practice claims that
seek to enforce the FDCA. J.A. 630. The FDA contended
that the FDCA precludes any claim that would “require[]
the Commission to directly apply, enforce, or interpret the
FDCA.” J.A. 631. The FDA further contended that the
Commission should decline to institute an investigation
based on principles of comity to the FDA. J.A. 629.

On October 27, 2017, the Commission issued its decision declining to institute an investigation and dismissing
the complaint. J.A. 1–3. The Commission reasoned that
Amarin’s allegations are precluded by the FDCA. Id.; see
also POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102,
109 (2014) (“Private parties may not bring [FDCA] enforcement suits.” (citing 21 U.S.C. § 337)).


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