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   November 2013

Arnall Golden Gregory LLP's (AGG) 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



Is Breakthrough Therapy Designation a Sponsor’s Golden Ticket?
By: Alan G. Minsk, Emalee G. Murphy and
Sari N. Bourne

The Food and Drug Administration Safety and Innovation Act, enacted on July 9, 2012, established Breakthrough Therapy designation, a new designation that expedites the review of drugs and biologics manufactured for serious or life-threatening conditions. This article discusses Breakthrough Therapy designation’s qualifying criteria and features, and takes a look at the implications of the designation. More > 

Fast Money – Fast Enforcement: FDA Issues Warning Letter for CEO’s Statements on a Cable Television Financial Show
By: William H. Kitchens and Alan G. Minsk

In a very interesting development, FDA’s Office of Prescription Drug Promotion issued a Warning Letter to a drug company, where the CEO was cited for oral statements made during two appearances on the CNBC cable television financial show, “Fast Money.” The show is intended for the investment community. This article will note FDA’s position and highlight our observations and recommendations. More >

FDA Proposes Significant Changes to Generic Drug Labeling Requirements, Which If Adopted, May Eliminate the Preemption of State Failure-To-Warn Claims For Generic Drug Companies
By: William H. Kitchens

On November 13, 2013, the U.S. Food and Drug Administration (FDA) published a proposed rule that will require generic drug firms to update the labeling of their drugs in light of new safety risks even though the labeling of the reference listed drug (RLD) for those products has different warnings, precautions, adverse reactions, contraindications and other information. If adopted, the rule change would likely negate a recent U.S. Supreme Court opinion finding that state failure-to-warn claims with respect to generic drugs.are preempted by federal law. More >



A Human Research Study Involving A Medical Food or Cosmetic May Require an IND
By: Alan K. Parver, Emalee G. Murphy and Leah Mendelsohn Stone

The Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and Center for Food Safety and Applied Nutrition (CFSAN) in September 2013 released a final guidance entitled “Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND.” The guidance finalizes a draft guidance that had been issued in October 2010. More >



Recent Developments in FCA Litigation
By: Sara M. Lord

As the federal government continues to expand its use of the False Claims Act (FCA) to recover billions in alleged false claims, the federal courts are increasingly being asked to limit the scope and reach of the FCA through motions to dismiss under the Federal Rules of Civil Procedure. Courts have examined whether the heightened pleading requirements of Rule 9(b) require complainants to identify the specific false claims that were presented to the government, or whether the mere allegation of underlying fraudulent activity is sufficient. The courts have also considered whether, in order for a claim to qualify as false under the FCA and survive a motion to dismiss under Rule 12(b)(6), the claim must have misrepresented that it complied with a material precondition of the payment. Several recent cases, including a Supreme Court request for the Government’s views in a pending petition for certiorari from the Fourth Circuit, have further highlighted these issues.  More >


The Dos and Don’ts of Social Media Disclosure
By: E. Terrell Gilbert, Jr.

Terrell Gilbert's article was recently featured in The Wall Street Journal.  The Food and Drug team at Arnall Golden Gregory feels that this article features a topic that also affects the Life Sciences industry.  As more companies let their CEOs and other top executives disclose key financial data on Facebook and Twitter, they need to remain vigilant to prevent postings that can put the business at risk of legal and regulatory problems. There has been a renewed focus on social media guidelines and policies for public companies this past year. More >

Industry Activities and Recognition

Alan Parver and Leah Stone Join Arnall Golden Gregory’s Healthcare Practice

Alan K. Parver, Partner, has spent three decades working on a wide range of Medicare coverage, payment, coding and claims processing issues that are important to health care providers and manufacturers of health care equipment and products. Since health care reform came to the fore in the early 1990s, Mr. Parver has built on that work to advise clients on far-reaching strategic issues as well. Presently, much of his practice involves developing health policy solutions for health care clients, particularly for the post-acute care sector with emphasis on specialty nutrition issues, infusion therapy, and medical products and services. More >

Leah Mendelsohn Stone, Associate, provides regulatory, legislative and policy counsel to a wide variety of health care clients, including several national associations and coalitions, professional societies, providers of home infusion therapy, manufacturers of enteral and parenteral nutrition, and hospitals and health care systems. She develops and implements effective advocacy strategies and successfully communicates complex health care policy issues to policymakers and regulators. Ms. Stone advises clients using her extensive expertise related to the Affordable Care Act, Medicare and Medicaid coverage and reimbursement, health care delivery reform, and prevention and health care quality initiatives. More >

Alan Parver was Quoted in Food Chemical News

AGG Partner Alan K. Parver was quoted in Food Chemical News in an online article entitled “FDA’s new definition for medical foods will restrict market, patient choices, says CRN”. The Council for Responsible Nutrition explains how a draft FDA guidance has the potential to derail food company plans to expand the medical foods market because some products would not qualify under the agency's new narrowed definition. More >

Sara Lord Interviewed in AHLA Connections

As part of the American Health Lawyers Association’s new quarterly series to celebrate women’s leadership, AGG Partner Sara M. Lord was interviewed for the September 2013 edition of AHLA Connections. The goal with this series is to give young professional members the ability to profile more of the experienced and uniquely situated AHLA members and leaders, to learn more about their path to success, and the challenges they have faced along the way.  


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.
©2013. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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