FDA Policy/General

Courts Could See FDA Warning Letter as Final Action

A recent DC federal court decision in a Centers for Medicare and Medicaid Services (CMS) case could be followed to a conclusion that courts may see FDA Warning Letters as final agency action. Attorney Michelle Yeary (Dechert) says in an online Drug and Device Law post that the case involved CMS letters about the Medicaid drug rebate program self-reporting scheme.

The letters issued by CMS in the case said they were not a final agency action or even an initial determination on a reimbursement claim, but the court held that the letters carried an increased risk of prosecution and penalties and thus were a “legal consequence” and met the definition of a final agency action.

“Think about an FDA Warning Letter that concludes that a specific sales aid is false and misleading because it omits risk information or includes unsubstantiated claims,” Yeary writes. “The letter will state that the specific sales aid misbrands the product under the Federal Food, Drug, and Cosmetic Act (FFDCA) and makes its distribution violative of FDA regulations. The letter will usually contain at least some examples of what FDA finds misleading or false. It will conclude with a request that the manufacturer cease using the sales aid (or cease misbranding the product) and take corrective action. The letter requires a response by the manufacturer in a given timeframe.”

Yeary says such a scenario is similar to the situation the court saw in the CMS case. She notes that Warning Letters do more than merely interpret a regulation because they apply the interpretations to the specific facts and reach conclusions about whether those facts violate the FFDCA. Such violations carry the risk of both civil and criminal penalties, she says, and FDA routinely uses Warning Letters to convey violations to manufacturers.

Yeary concludes that while she is not persuaded that the court reached the correct conclusion in the CMS case, it’s still important to recognize that the potential exists for a court to see a Warning Letter as final agency action and to be ready with legal arguments to challenge that position.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome