A recent ruling by the DC Appellate court may have drastic implications for FDA’s ability to “Release with Comment” entries that contain FDA violations.
In Cook v. FDA, prisoners on death row brought suit against FDA complaining that the Agency failed to refuse admission to an imported unapproved and misbranded drug used for lethal injection that, “came from an unregistered manufacturing facility.” FDA argued it had discretion to permit the importation. The court ruled in favor of the prisoners, stating that the wording of the Federal Food, Drug, and Cosmetic Act (“FFDCA”) requires FDA to refuse shipments of imported drugs once FDA finds the drugs appear to violate some substantive provision of the FFDCA.
The relevant statute states if any imported article “appears” to violate the Act, then FDA shall refuse entry to the shipment unless it can be “reconditioned” (reworked or relabeled etc., to bring it into compliance).
So does “shall” mean “must” or does it mean “may?” The plaintiffs argued that FDA must refuse admission to the lethal injection drug components because FDA found they appeared to violate the law. As you might imagine, FDA did not like its hands tied. FDA argued that the Agency had discretion to decide which shipments should be refused and which shipments it should not expend enforcement resources on. FDA lost.
In its opinion, the court found the FFDCA uses the word “shall” in many parts to impose mandatory obligations on FDA. Specifically, section 381(a) (the primary import provision) states that, if any drug is manufactured in a non-registered facility and offered for import, FDA “shall” request samples and “shall” refuse admission if it is found to violate the Act. The court found that the textual language requires FDA to request samples, examine them for violations, and then refuse any drug shipment that FDA finds appears to violate the FFDCA. One such violation is where the drug comes from a foreign, unregistered drug establishment.
This creates a significant problem for FDA. Not because the Agency is so keen on permitting the importation of drugs used in lethal injections, but because there are many circumstances when FDA decides not to refuse (and expend additional regulatory resources on) shipments that bear minor violations that do not impact public health.
Prior to the ruling, FDA exercised discretion to release, with comment, shipments of products that were technically violative in ways that did not present a public health threat, usually with the promise that future shipments of the same products would bear appropriate corrections.
However, if FDA loses the “Release with Comment” authority, it complicates how FDA decides to expend its inspection resources.
Arguably, the Court’s rendering of the statute wipes out FDA’s ability to “Release with Comment” a shipment that bears a technical, non-safety-related violation and requires refusal of admission. This is an expensive outcome: expensive to FDA and expensive to the market. FDA has traditionally reserved its “Release with Comment” disposition for shipments bearing minor FFDCA violations, such as not properly bolding required language in a Nutrition Facts Panel. Applying the reasoning in Cook, if FDA finds any evidence related to an imported article that gives rise to the appearance of a violation (e.g., related to adulterated or misbranded) then FDA must either (1) refuse the entry or (2) allow the importer to recondition and bring the article into compliance. That will increase the cost of the import transaction – and with the rising number of imports, the cost of products on retail shelves.
It could be that the case is narrow: relating only to drugs – or more – related only to drugs imported from unregistered foreign facilities (because there are two “shall”-s involved in the charge). But it is not so easy to see how to limit the holding even to drugs, much less to specific kinds of drugs.
For over 100 years, FDA has interpreted the “shall” in the import provision of the FFDCA to mean “may” because other provisions grant FDA the discretion to decide which cases to prosecute. But in the D.C. Circuit, at least, it seems “shall” means “must” when confronting imported drugs and FDA’s discretion is limited to whether an appearance of a violation exists – not whether it may release a shipment once FDA has discovered the appearance of a violation.
No one will be happy with this ruling in the long run. It complicates FDA’s import review, screening, examination and sampling processes, it increases risks to importers and foreign suppliers with respect to non-public health-related violations, and will increase the cost of imported products on U.S. retail shelves.
