August 2015 | |||||
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice. In this Issue
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Industry Insights | |||||
PHARMACEUTICALS Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination The Food and Drug Administration has lost yet another court decision challenging its ability to restrict a company’s commercial free speech rights. To quote the rock band Queen, Another One Bites the Dust. In the most recent court decision, a U.S. District Court granted a drug company’s preliminary injunction to prohibit FDA from taking enforcement action against the company’s distribution of information about an unapproved use of its FDA-approved product. We have summarized the facts of the case, highlighted key elements of the 70-page decision, and offered several observations. More > | |||||
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MEDICAL DEVICES Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures | |||||
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NEWS FROM WASHINGTON FDA Issues Guidance to Streamline Review of 510(k) Submissions. A Clear Path Forward? | |||||
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Key Ruling In False Claims Act Case Could Have Important Implications For Defendants A recent decision of a United States District Court in Alabama may signal that the playing field traditionally dominated by the government will no longer be so one-sided against providers defending against False Claim Act (“FCA”) claims. In United States v. AseraCare Inc., No. 2:12-CV-00245-KOB (N.D. Ala. June 25, 2015) (the “Reconsideration Order”), the Northern District of Alabama affirmed its previous grant of AseraCare’s request for bifurcation, ordering the trial to be conducted in two phases: one phase on the falsity element of the government’s FCA claim, and a second phase on the other elements of the FCA claim and all other claims. That is, the government must first prove an “objective falsehood” in the claims submitted by the defendant before being able to present evidence that the defendant acted knowingly. See Reconsideration Order, pg. 1. In bifurcating the trial, the district court acknowledged the inherent prejudice, jury confusion, and waste of resources caused by allowing the government to present evidence of general corporate practices unrelated to specific patients before a determination has been made as to whether the claims in question are, in fact, false claims. Id. at 5. More > Necessary Ingredients for Sound Legal Holds Whenever e-discovery and healthcare litigation and investigations come up, you can almost always count on the topic to include a discussion of sanctions. That’s not an accident. There has been an uptick in both the volume of filings asking for discovery sanctions and orders granting those requests. And, for better or for worse, these trends don’t seem to be at risk of abating. More > | |||||
Industry Activities and Recognition | |||||
AGG Partner Quoted in The Pink Sheet and The Gray Sheet Alan G. Minsk was quoted in the August 17th edition of The Pink Sheet and The Gray Sheet on the recent ruling in the Amarin First Amendment court case that is increasing pressure for FDA policy change. Mr. Minsk spoke about the possible ramifications and remaining issues to consider. AGG wrote a bulletin on the court decision, noted above. Michael E. Burke recently authored on the topic “What Life Sciences Companies Need to Know About the Foreign Corrupt Practices Act” which was published by the Regulatory Affairs Professionals Society’s online magazine, Regulatory Focus. The article gives an overview of the Foreign Corrupt Practices Act and practical and effective compliance strategies for life sciences companies. Alan G. Minsk will serve on the Board of Directors for the early-stage pharmaceutical company, AbbyMed, LLC. The company intends to commercialize technologies invented in partnership between the Georgia Institute of Technology and Emory University. AGG Partner Marks 36th Year of Teaching Food and Drug Law at Emory University School of Law William H. Kitchens, who advises companies in the medical device, pharmaceutical, biotech, and food industries, began serving as an adjunct professor at Emory University School of Law in 1979. The Fall Semester 2015 marks his 36th year of teaching food and drug law. | |||||
Upcoming Events | |||||
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