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  May 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



What 21st Century Cures Will Mean For Clinical Trial Sponsors
By: Alan G. Minsk and Alan K. Parver

The House Energy & Commerce Committee, Subcommittee on Health recently released a draft bill that has bipartisan support and will, if enacted, dramatically alter the landscape of pharmaceutical and medical device regulation and development in the U.S. The discussion draft, known as the 21st Century Cures Act (Cures Act), is divided into five major sections, each focused on a set of legislative and regulatory proposals intended to transform, accelerate, and advance the development of new drugs and devices, as well as streamline the clinical trials process. 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 (“ACA”) 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 (“IRS”) 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 >

A Funny Thing Happened on the Way to the Pharmacists Meeting
By: Alan G. Minsk

The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued recently a Notice of Violation to a generic drug company for unlawful promotion. While each enforcement letter has its own fact-specific deficiencies, a few items caught our eye. More > 

Break on through to the Other Side: An Update on Breakthrough Therapy Designation Requests
By: Alan G. Minsk

A recent public meeting on Breakthrough Therapy (BT) Designation after 2½ years from implementation provided some interesting insight and trend information, but we thought some of the data presented at the meeting was useful as companies consider where to pursue the BT option. More >



Former Senior Executives Indicted for Illegal Marketing of a Medical Device
By: Alan G. Minsk and Alexander B. Foster 

Two former senior executives were indicted with violations of the Food, Drug, and Cosmetic Act relating to the introduction of adulterated or misbranded medical devices into interstate commerce, a violation of law. The indictment alleges that the two executives marketed a device for uses not approved by FDA, i.e., off-label uses. The executives have not been convicted.
 More >



FDA and the FTC Unfriend a Dietary Supplement Product
By: Alan G. Minsk and Alexander B. Foster 

In an interesting Warning Letter recently issued, both the Food and Drug Administration and the Federal Trade Commission issued a Warning Letter to a dietary supplement company for promoting its product as a drug. Without going into the details of the case, we will highlight some of the issues we thought noteworthy and instructive.
 More >



What Foreign Life Sciences Companies Need to Know About Selling to the U.S. Government
By: Tenley A. Carp and Jeffrey S. Jacobovitz

Foreign companies, such as life sciences companies, should take advantage of the opportunity to sell to the U.S. Government. A foreign company need not have a U.S. presence in order to sell to the U.S. Government. The U.S. Government is the single largest customer in the world – buying approximately $500B worth of products and services per year. In addition, government contracts are long – they are typically 5 years rather than only one year which provides a company with a predictable revenue for a long period of time. Plus, many companies want to sell to the Government because the projects are often cutting-edge – and the Government will permit companies to include Independent Research and Development costs into its indirect cost pool. And, most importantly, the U.S. Government always pays its bills. More >

Industry Activities and Recognition 

AGG Partner Spoke at Program on Telehealth-Transforming the Delivery of Healthcare

William H. Kitchens, spoke on Telehealth-Transforming the Delivery of Healthcare on May 7, 2015 at a joint program sponsored by Georgia Bio and the Metro Atlanta Chamber of Commerce’s Bioscience-Health IT Leadership Council. More >

AGG Partner Presented at the ABA Health Care Fraud National Institute

Glenn P. Hendrix, presented at the 25th Annual National Institute on Health Care Fraud on May 15, 2015. The workshop included a discussion of current trends and issues in government investigations related to fraud and abuse in the long-term care setting. More > 

AGG Partner Provided Webinar on FDA Formal Dispute Resolution Above the Division Level

Alan G. Minsk, presented a one-hour webinar entitled “FDA Formal Dispute Resolution Above the Division Level: I Fight Authority, Authority Always Wins (or Does It?)” on May 20, 2015. The webinar included a discussion of FDA’s guidance on the formal dispute resolution process and appeal options, as well as potential benefits and risks of exercising these options. A recording of the webinar is available upon registration. More >

Upcoming Events 

AGG Partner Alan G. Minsk will present “Regulation of Drug Marketing" at the Food and Drug Law Institute’s Introduction to Drug Law Conference in Washington, DC on May 29, 2015.

AGG Partner Alan G. Minsk will present “Designation and Exclusivity (Orphan, Fast Track, Breakthrough) and How These are Changing – How to Avoid Loss of These Designations" as part of a Mapi Group Workshop in Washington, DC on June 15, 2015.

AGG Partner Alan G. Minsk will present “Off-Label Promotion – Social Media Pitfalls" at the Social Media Regulatory Affairs Summit in Washington, DC on June 25, 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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