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 | |||||
PHARMACEUTICALS States Seek to Expand Access to Investigational Drugs, Biological Products, and Devices Through “Right to Try” Laws 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 > | |||||
| |||||
MEDICAL DEVICES Off-Label Promotion, State-Level Injury Lawsuits, and Preemption | |||||
| |||||
FOOD FDA Issues Ban on Artificial Trans Fat in Processed Foods | |||||
| |||||
A Powerful New Tool For Ensuring Speedy and Efficient Arbitrations in the Healthcare Industry 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 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 | |||||
| |||||
Comments | Manage your Subscription | Forward to a Friend | ##UNSUBSCRIBE_TEXT## |