An FDLI Update article by Riëtte van Laack and John R. Fleder highlights the risk of aggressively defending your position against the FDA at any time. A recent court ruling, United States v. Kaminski, shows the potential perils faced. Ovimmune, Inc., and its owners may have found themselves with enhanced criminal sentences after they allegedly obstructed justice by complaining about FDA’s allegedly poor treatment of them during an investigation of defendants’ hyperimmunized eggs product.
According to the article, “Ovimmune was a small corporation and the sale of the hyperimmunized eggs, although found to be adulterated and misbranded, did not apparently cause any physical harm. Nevertheless, the hostilities that developed during the government’s investigation may well have caused the prosecution to be initiated, and surely increased the sentences that were imposed after conviction.”
On a related now, the first months of the new administration are a poor time to test the limits of the law. New FDA administrators who want to signal a change are likely to look for cases that send the message, “There’s a new sheriff in town!”
Hat tip to the FDA Law Blog.