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  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

 Industry Insights



Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination
By: Alan G. Minsk and William H. Kitchens

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 >



Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures
By: Kevin Coy and Andrew B. Flake 

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a manufacturer does not address data privacy and security, it could face a wide range of regulatory consequences from multiple agencies. Hacks are a major risk, as is intellectual property theft. So what should a medical device manufacturer take into account when it comes to privacy and security safeguards? This article offers some best practices and insights for the medical device manufacture who is handling health information.
 More >



FDA Issues Guidance to Streamline Review of 510(k) Submissions. A Clear Path Forward?
By: Alan K. Parver  

On August 4, 2015, the Food and Drug Administration’s Center for Devices and Radiological Health released a new guidance document intended to provide applicants with clear and consistent guidance in the submission and initial intake evaluation process of 510(k) submissions. It explains the procedures and criteria that FDA will use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and whether it will be accepted for substantive review.
 More >



Key Ruling In False Claims Act Case Could Have Important Implications For Defendants
By: Aaron M. Danzig and J. Ryan Hood

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
By: Scott A. Wandstrat

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.

AGG Partner Published in RAPS Regulatory Focus

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.

AGG Partner to Serve on Board of Directors for Pharmaceutical Company

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 

AGG Partners Hedy S. Rubinger and Steven A. Kaye will present a webinar entitled "Healthcare REITs: Navigating Regulatory Challenges and Minimizing Liability Risk" on September 10, 2015.

AGG Partner Alan G. Minsk will present “ANDAs 101: A 10,000 Ft. Overview of FDA Regulation of Generic Drugs” at the UPPI Annual Conference in Sarasota, FL on September 24, 2015.

This newsletter is published by Arnall Golden Gregory’s Food and Drug and Government Affairs and Public Policy Practices. This information presented provides a general summary of recent legal and regulatory developments. It is not intended to be, and should not be relied upon, as legal advice. For more information about the Food and Drug Practice, please contact Alan Minsk.
©2015. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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