FDA Warning Letters: Knocking on the Doors of Courthouses

by Katelyn DeRuyter, UMN Law Student, MJLST Staff

Thumbnail-Katelyn-DeRuyter.jpgThe FDA is responsible for safeguarding public health by “assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” The FDA inspects products and manufacturing facilities in order to ensure these important goals. If the inspection finds that a company has fallen short of the applicable standards, the FDA often will issue a Warning Letter.FDA_Letter.jpg An FDA warning letter is written correspondencee “that notifies regulated industry about violations that FDA has documented during its inspections or investigations.” The FDA views warning letters as giving the recipient an opportunity to take voluntary and prompt corrective action before the FDA initiates official enforcement action. Despite the fact that the FDA Warning Letter is considered a mechanism for inducing “voluntary” compliance, in recent student note published in Issue 12.2 of the Minnesota Journal of Law, Science & Technology, entitled “FDA Goes Loko,” Rebecca Boxhorn argues that warning letters do not induce truly voluntary compliance because recipients that do not wish to voluntarily comply have limited options. Under the current state of the law, FDA Warning Letters are not subject to judicial review. This lack of judicial review is problematic because warning letters subject recipients to real consequences. Boxhorn proposes that FDA Warning Letters should be subject to judicial review.

This positions runs contrary to current case-law but is supported by many industry participants. The crux of the Boxhorn’s argument is that given the consequence of receiving a warning letter, “judicial review of warning letters must be allowed to protect regulated parties from agency coercion and potential misapplications of the law.”

A recent Supreme Court decision in Sacketts v. EPA has sparked speculation over whether courts will begin to re-evaluate their previous view of FDA Warning Letters as not fit for judicial review. The Court in Sackett analyzed whether an EPA Compliance Order constituted final agency action that was subject to APA judicial review. The Sacketts brought suit in U.S. District of Idaho claiming the EPA’s compliance order was arbitrary and capricious and deprived them of life, liberty, or property, without due process of law, in violation of the Fifth Amendment. The district court dismissed the claims based on the lack of subject matter jurisdiction and the Ninth Circuit affirmed. The Court granted certiorari, reversed the Ninth Circuit’s decision, and held that the contested compliance order constituted “final agency action for which there [was] no adequate remedy other than APA review, and that the Clean Water Act does not preclude that review.”

The Court analyzed whether the compliance order in question constitutes final agency action and concluded that it “has all of the hallmarks of APA finality that our opinions establish.” The opinion walked through three factors that support the finding that the compliance order is final agency action: (1) the fact that “[t]hrough the order, the EPA ‘determined’ ‘rights or obligations;'” (2) the fact that “‘legal consequences . . . flow[ed]’ from issuance of the order;” and (3) that the agency action “mark[ed] the ‘consummation’ ‘of the agency’s decision making process.'” Whether applying Sackett would lead a court to conclude that an FDA warning letter is final agency action depends on the extent to which the warning letter in question is similar, or dissimilar, in language and ramifications, to the compliance order addressed in Sackett–at least in regards to the “hallmarks of finality.” A key component of the Sackett Court’s analytical approach is the fact that the Court looked beyond the EPA’s stated intent of compliance orders, and evaluated the actual effect of the compliance order on the Sacketts. If courts adopt this approach and look at the consequences of receiving a warning letter, recipients might finally gain access to judicial review.