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   June 2016

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



FDA Streamlines the Expanded Access Approval Process for Individual Patients
By: Alan K. Parver and Cathy M. Fortney

The U.S. Food and Drug Administration (FDA) just made it easier for physicians to get critically needed, but not yet approved in the U.S., treatments to some of the nation’s most critically ill patients. FDA Commissioner Robert Califf announced recently the release of a new form designed to help expedite the process for physicians to obtain “expanded access” or “compassionate use” approval for investigational new drugs (INDs) and biologics for individual patients. Under the Federal Food, Drug and Cosmetic Act (FDCA), a physician may request expanded access to investigation new drugs and biologics, and the request must meet certain criteria for FDA to authorize expanded access (FDA says that it approves 99 percent of requests). Individual patient expanded access submissions made by private physicians are submitted as new INDs. The new Form FDA 3926, Individual Patient Expanded Access Investigational New Drug, was created to ease the paperwork burden on physicians seeking approval for individual patients who suffer from serious or immediately life-threatening diseases and for whom no comparable or satisfactory alternative is available. More >

Second Circuit Affirms Dismissal of False Claims Act Suit Based on “Off-Label” Marketing
By: W. Jerad Rissler

The United States Court of Appeals for the Second Circuit recently affirmed an Order of the Eastern District of New York dismissing a qui tam False Claims Act (FCA) suit based on “off-label” marketing of prescription drugs. The Second Circuit agreed with the district court’s conclusion that the qui tam complaint at issue failed to allege any “off-label” promotion or prescriptions and affirmed the district court’s dismissal on that basis. It added (though it made clear that it was not deciding the issue and that its holding was not based on this reasoning) that it was “skeptical” that “off-label” promotion could lead to FCA liability, at least where the “off-label” promotion is not “for a purpose obviously not contemplated by the label.” More >



FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices by Device Manufacturers
By: Alan G. Minsk

On June 10, 2016, the Food and Drug Administration issued a draft guidance for industry and agency staff entitled, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers.” FDA will accept comments for 60 days from that date. While not legally binding on FDA or industry, the draft offers the agency’s current thinking and recommendations on how medical device companies can share certain information with patients. More > 



The First Cut is the Deepest: FDA Issues a Warning Letter to a Skincare Company for Marketing Unapproved New Drugs
By: Alan G. Minsk

The Food and Drug Administration recently issued a Warning Letter to a skincare company for promoting and selling unapproved new drugs. While the letter itself is not unusual in content, the enforcement action continues a trend we are seeing where the agency, whether at Headquarters or at the District Office level, will take action against products with purported cosmetic claims that FDA contends are unapproved new drugs. As Cat Stevens sang, “The first cut is the deepest.”  More >



Guidance on Effective Self-Disclosure of FCPA Violations for Life Sciences Companies
By: Michael E. Burke

Every life sciences company with international operations should have a robust Foreign Corrupt Practices Act (FCPA) compliance program as part of its overall compliance strategy. On April 5, 2016, the Justice Department announced the launch of a one-year pilot program (Pilot Program) focused on the scope of credit that companies can expect to receive for self-disclosing FCPA violations. On the same day, the Justice Department also announced that it had increased the amount of resources devoted to the investigation and prosecution of FCPA cases. The announcement of the Pilot Program left many FCPA practitioners unclear as to the specific steps a company must take in order to receive ‘credit’ under the Pilot Program. More > 

Industry Activities and Recognition 

Three AGG Healthcare/Life Sciences Partners Listed in the 2016 Chambers USA Guide to Outstanding Lawyers

Chambers, one of the leading ranking services for lawyers and law firms worldwide, recognizes 16 AGG partners in its latest guide, including the following three attorneys from AGG’s Healthcare/Life Sciences Practice: Glenn P. Hendrix, Alan G. Minsk, and Hedy S. Rubinger. AGG’s Healthcare Practice also is Chambers rankedMore >

AGG Attorney Barbara Rogers Selected for American Health Lawyers Association Leadership Development Program

On May 23, 2016, Barbara J. Rogers was selected by the American Health Lawyers Association (AHLA) to join the Academic Medical Centers and Teaching Hospitals Practice Group 2016-2017 Leadership Development Program (LDP). The LDP begins in July, following the AHLA Annual Meeting in Denver, Colorado. More >

AGG Attorney Alexander Foster to Serve on Walk to End Alzheimer’s Committee

AGG attorney, Alexander B. Foster, has joined the Walk to End Alzheimer's Community Outreach Committee. The Committee's purpose is to increase awareness and stimulate interest in the Walk to End Alzheimer's event, which plays a major role in raising funds for Alzheimer's care, support and research. More >

AGG Attorney Barbara Rogers to Serve on HeLP Advisory Council

AGG attorney Barbara J. Rogers is the newest member of the Health Law Partnership (HeLP) Advisory Council. The HeLP Advisory Council provides on-going advice on legal, ethical, and practical issues in the operation of HeLP as a community partnership. The Council also assists HeLP with its educational programs, fundraising, pro bono services, program evaluation and research, and public relations. More >

Upcoming Events

AGG Partners Sherman A. Cohen and Andrew B. Flake will present a complimentary breakfast briefing, “Growth, Funding, and Exit Strategies for the Healthcare IT Company” on June 21, 2016.

AGG Partner Alan G. Minsk will present "Drug/In Vitro Diagnostic Device Advertising and Promotion: Unapproved Combination Product or Awareness?" at the Drug Information Association Annual Meeting in Philadelphia, PA on June 27, 2016.

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.
©2016. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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