Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has approved of certain other uses for such drug/device)–and the FDA’s restrictions on the same. In a recent case (Amarin Pharma, Inc. v. United States Food and Drug Administration, August 5, 2015), the 2nd U.S. Circuit Court of Appeals held that the FDA cannot prosecute companies and their representatives under the Federal Food, Drug, and Cosmetic Act for truthful, non-misleading discussion, even if about off-label uses for a drug/device. Further, the court enjoined FDA in the case from considering the off-label communications to be evidence of misbranding. The decision makes clear that false or misleading statements are not protected speech. This decision is binding only within the jurisdiction of the Federal Second Circuit Court of Appeals: Federal courts in New York, Connecticut, and Vermont. However, the decision is clearly a win for industry to communicate proactively truthful and non-misleading information about clinical trial results. My colleagues Alan Minsk and Bill Kitchens have written an excellent client alert on this case and its impact, available here. Despite the questionable use of a song title from the band Queen, the update is well worth the time for any Irish or NI life sciences company operating in, or looking to expand to, the U.S.
In yesterday’s post, I wrote about how an effective set of terms and conditions (U.S.-style), consistently used, was one of the most (if not the most) important pieces to an Irish/Northern Irish company’s risk mitigation strategy. To complete that thought, please take a look at this checklist: Terms and Conditions Checklist that will provide some guidance on developing effective terms and conditions.
I spoke recently with the owner of an Irish company that sells its products online to purchasers in the US and other countries. The US isn’t a true focus of this company’s expansion efforts, but the US market is a nice added benefit to the company’s revenue stream. They don’t have a US-specific website, but if you go to their order page you can enter a US address for delivery. In discussing their sales efforts, I asked what the company does in terms of US-focused terms/conditions of sale and related agreements. Nothing, I was told, because the company isn’t ‘doing business’ in the United States. In a limited way, that answer is correct. But, that answer also is wrong, and dangerously so. Continue reading