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  June 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



States Seek to Expand Access to Investigational Drugs, Biological Products, and Devices Through “Right to Try” Laws
By: Alan G. Minsk and W. Jerad Rissler

Since early 2014, at least forty states have introduced “Right to Try” laws, and twenty-two of those states have passed “Right to Try” laws. The goal of these laws is provide patients with terminal illnesses access to investigational drugs, biological products, and devices which have not yet received full FDA approval. This article will discuss these “Right to Try” laws, the laudable goals behind such legislation, the federal regulatory context in which these laws exist, and some legal and practical obstacles to full recognition of the goals of this legislation. More >



Off-Label Promotion, State-Level Injury Lawsuits, and Preemption
By: Alan G. Minsk 

The issue of preemption in product liability cases involving medical device products continues to evolve. Recently, the U.S. Court of Appeals for the 10th Circuit found that federal law preempts injury and negligence claims, brought under state law, even if the claims arise out of potential off-label promotion by the device manufacturer. The decision seemingly reaffirms a trend toward preemption although, with all cases, tort claims are fact- and pleading-specific.
 More >



FDA Issues Ban on Artificial Trans Fat in Processed Foods
By: William H. Kitchens and Alan G. Minsk  

On June 15, 2015, the U.S. Food and Drug Administration announced a final determination order regarding the use of partially hydrogenated oils (PHOs) in foods manufactured for human consumption, concluding that PHOs are not generally recognized as safe (GRAS) and, therefore, are “food additives” that require prior FDA approval.
 More >



A Powerful New Tool For Ensuring Speedy and Efficient Arbitrations in the Healthcare Industry
By: Henry R. Chalmers

A powerful new tool has just been created for companies seeking quick, efficient, and private resolution of business disputes. The Delaware Rapid Arbitration Act (DRAA or the Act), enacted in April 2015, streamlines the process for initiating an arbitration, sets tight deadlines for concluding it, automatically confirms the arbitration award, and provides speedy resolution of any challenge directly to the Delaware Supreme Court. The DRAA cleverly ensures quick completion of the process by imposing financial penalties on the arbitrator if a final decision is not issued within 120 days of commencement. If this sounds appealing, consider including DRAA provisions in your future contracts. More >

Prohibited Employer Health Insurance Premium Reimbursement Arrangements – Immediate Action Required
By: Warren E. Kingsley and Douglas A. Smith

Understandably, the general focus on the Affordable Care Act the last few years has been on ACA constitutionality, the employer and individual mandates, operation of the ACA health insurance exchanges (the “Health Insurance Marketplace” or “Marketplace”) and premium tax credits thereunder, and the impact of the ACA on provider networks. Employers, however, should be aware that Internal Revenue Service and other U.S. government agency guidance has struck down a previously benign practice that employers (particularly small ones) have used to provide health insurance coverage to a limited number of valuable employees (e.g., when the employer does not otherwise offer employees group health coverage): Reimbursements to employees who purchase their own health insurance. More >

Industry Activities and Recognition 

AGG Partners Co-Author Newsletter Providing Insight on Corporate Integrity Agreements

Sara M. Lord and Aaron M. Danzig co-authored a newsletter article, “Corporate Integrity Agreements After 20 Years: The Burgeoning Costs of Settling FCA Cases and Fending Off Medicare Exclusion,” for the American Health Law Association's Fraud and Abuse Practice Group newsletter.

Upcoming Events 

AGG Partner Alan G. Minsk will present “Drugs and Biologics: Labeling" at the American Conference Institute's 25th FDA Boot Camp in San Francisco, CA on July 21, 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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