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.
Businesses operating in or expanding to the US, including those from Ireland and Northern Ireland, use independent contractors to avoid some of the baggage associated with the employer/employee relationship under US law. The use of independent contractors recently has gotten more complicated due to the US Department of Labor’s publication of Administrator’s Interpretation 2015-1. The Interpretation is part of the Department’s closer monitoring of the ‘independent contractor’ designation. Businesses from Ireland or Northern Ireland operating in or expanding to the US, and using the services of an independent contractor (such as a sales agent) should take another look at how they designate a person as an ‘independent contractor,’ as soon as possible. Continue reading
It’s been a while…my apologies! Waiting at an airport on a winter weather delay has me thinking of all the times I’ve been delayed because of summer weather like…lightning storms. It also gave me a chance to talk to a non-US company client about doing business here, and their structuring options; which also relates to my earlier post about when a company is deemed to be doing business here, for jurisdictional purposes.