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Update: Court Decision Strengthens FDA’s Unapproved Drug Initiative Enforcement

Just a few days after our recent blog about a lawsuit filed against the FDA by two drug manufacturers, the complaint was dismissed in federal court.

At its heart, the lawsuit challenged the FDA’s authority in two respects. First, the lawsuit targeted the FDA’s unapproved drug initiative, which seeks to remove unapproved versions of pharmaceutical products from the market, especially in cases where an approved version of that particular drug exists. Second, although not explicitly described as such, the lawsuit, if successful, would have arguably weakened the FDA’s authority to issue warning letters – not only as part of the agency’s Unapproved Drug Initiative, but overall.

In dismissing the complaint, the court focused in part on the fact that a warning letter from the FDA is just that – a warning – and is not (yet) an enforcement action. As such, the court found, the case was not “ripe” for adjudication, since no enforcement action had actually been taken.

Because (the drug manufacturers) are attempting to enjoin an anticipated enforcement action…(granting the manufacturers’ request) would be without foundation and a wholly inappropriate interference with FDA’s charge to protect the public health. (…) Plantiffs seek to enjoin a possible future FDA enforcement action to remove their unapproved (drug) from the market.

Stepping back from this particular decision, it is worth remembering that the warning letter process utilized by the FDA is not the normal course of action for enforcement and regulatory agencies: for example, the DEA or FBI, if they investigative and detect the illegal sale of pharmaceutical products, will generally not “warn” a potential defendant, but will simply act, via arrest or indictment. FDA may certainly do the same, but the warning letter process arguably saves significant resources by effectuating compliance without launching a formal legal process.

While the decision might be appealed, for now, the court’s decision indicates that the FDA’s Unapproved Drug Initiative specifically, and warning letter process generally, remain on solid legal ground.