Newest FDA Newsletter from AGG

Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and has several updates of interest for Irish and Northern Ireland life sciences companies operating, or looking to operate, in the US: (i) additional discussion of the Amarin off-label promotion case; (ii) guidance for data-driven medical device companies on implementing effective data security and privacy measures; and (iii) potential changes that could streamline 510(k) medical device reviews at FDA. If you have questions or comments about the newsletter, please contact me or the author(s) of the articles in question.

Happy reading!

 

 

Life Sciences Companies and Free %$&*@# Speech

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.

US FDA Updates for Irish and Northern Irish Companies

AGG produces a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from our Washington, DC office. The June 2015 update is located here. Two items should be of particular interest to Irish and Northern Irish companies whose products fall under US FDA regulation: Continue reading

Webinars for Irish and Northern Irish Companies (free content, too!)

Late last year, we held a series of webinars directed to Irish and Northern Irish companies looking to do (or doing) business in the US. The webinars were well-attended, and, in part, led to the creation of this blog. We want to share those webinars, and their content, with you.

The first webinar introduced the concept of ‘smart exporting’ and provided a high-level view of some key legal issues relevant to Irish and Northern Irish companies in the US market. The presentation for this ‘smart exporting’ webinar can be found here; the recording of the webinar (requires registration) can be found here.

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