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   September 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

     

PHARMACEUTICALS

Expediting Drug Importation: FDA’s New Secure Supply Chain Pilot Program
By: Emalee G. Murphy and
Sari N. Bourne

The legal requirements that apply to drugs manufactured in the United States also apply to imported drugs, and the Food and Drug Administration (FDA) can stop importation at the border by refusing admission of any drug that appears to be adulterated, misbranded, or an unapproved drug. Currently, many drugs imported into the United States undergo a lengthy entry review process, and, with the increasing number of imported goods that the FDA regulates, the process remains a significant barrier to rapid entry. However, companies may now be able to expedite the importation of their low-risk drug products in certain circumstances. More >


 

MEDICAL DEVICES

New Government Scrutiny of Medical Device Companies Regarding False Claim Statutes
By: Sara M. Lord and Sari N. Bourne

The government has long investigated healthcare providers and pharmaceutical companies for False Claims Act (FCA), Federal Food, Drug, and Cosmetic Act (FDCA), Anti-Kickback Statute (AKS), and other related violations of federal law. It now appears that the government has expanded its investigative focus to include medical device companies.  More >

Medical Device Tax Repeal: Delayed, but Not Forgotten
By: Kim Phan

The Patient Protection and Affordable Care Act (“PPACA”) (P.L. 111–148) included a medical device excise tax of 2.3%, which took effect in January 2013, and is estimated to impact more than 8,000 medical device manufacturers throughout the United States. Despite broad, bipartisan support among Members of Congress to repeal the tax, legislative activity in this area has slowed to a crawl. The sense of urgency that accompanied prior repeal efforts from last year, before the tax went into effect, has greatly diminished. Thus, the medical device excise tax is expected to remain in place for the foreseeable future. Whether the tax is ultimately repealed will likely be decided as the Congress takes up comprehensive tax reform. More >


 

FOOD

FDA Publishes Revisions to Medical Foods Draft Guidance
By: Emalee G. Murphy
 

The Food and Drug Administration has proposed an update to its May 2007 draft guidance titled, “Draft Guidance for Industry: Frequently Asked Questions About Medical Foods.” The revisions to the draft guidance describe the agency’s current thinking about medical foods and indicate the direction that any enforcement actions are likely to take.  More >


 

NEWS FROM WASHINGTON

Mitigating FCPA Exposure in International Distribution Relationships
By: Michael E. Burke

Mitigating the risk of sanctions under the U.S. Foreign Corrupt Practices Act (FCPA) is a core concern in every international commercial transaction, including cross-border distribution relationships in the FDA-regulated industry sectors. The FCPA contains both anti-bribery and accounting provisions. The anti-bribery provisions prohibit U.S. persons and businesses, U.S. and foreign public companies listed on stock exchanges in the United States or which are required to file periodic reports with the Securities and Exchange Commission, and certain foreign persons and businesses acting while in the territory of the United States from making corrupt payments to foreign officials to obtain or retain business. The accounting provisions require issuers to make and keep accurate books and records and to devise and maintain an adequate system of internal accounting controls. The U.S. Department of Justice and the Securities and Exchange Commission share enforcement authority under the Act. This article will review briefly best practices to mitigate FCPA risk in international distribution relationships.  More >


  

SUNSHINE SERIES

Physician Payment Sunshine Act Updates
By: H. Carol Saul, Jennifer Downs Burgar and Lanchi Nguyen Bombalier

In an effort to assist our clients and friends with implementation of the final regulations promulgated pursuant to the Physician Payment Sunshine Act (Section 6002 of the Patient Protection and Affordable Care Act), we are providing updates in a “Sunshine Series” of articles. Our Sunshine Series provides information on the government’s preparations for information collection and publication (and eventual enforcement), practical tips for compliance, interesting nuances in the final regulations, State law preemption, and responses to general-interest questions posed by our clients.  


Industry Activities and Recognition

William Kitchens and Alan Minsk Contribute to Major New Book on Medical Device Regulation

AGG partners, William Kitchens and Alan Minsk, wrote the chapter on “Interacting with FDA” in the book “Medical Devices Law and Regulation Answer Book 2014” published by the Practicing Law Institute in late August, 2013. The book distills the essential elements of a complex regulatory environment and provides in a single resource a practical guide to the complexities of the Food and Drug Administration’s regulation of medical devices. The chapter written by Messrs. Kitchens and Minsk addresses both formal and informal interactions with FDA and provides practical guidance on how to develop favorable outcomes with FDA and build a successful long-term relationship with the agency. More >

Emalee Murphy Contributes to the Food and Drug Law Institute's (FDLI) Primer

Emalee Murphy contributed a chapter on Veterinary Drug Product Promotion and Postapproval Surveillance in the Food and Drug Law Institute’s (FDLI) primer entitled "FDA Regulation of Animal Drug Products". More >  


Upcoming Events 

Emalee G. Murphy will moderate a session at the Food and Drug Law Institute’s Advertising and Promotion Conference in Washington, DC on “Top Cases of 2012 and 2013: The Changing Legal Environment” on September 17, 2013.

Alan G. Minsk will present two sessions on advertising, promotion and labeling of medical devices at the 2013 Annual Meeting of the Regulatory Affairs Professionals Society in Boston, Massachusetts on September 30, 2013.

Alan G. Minsk will co-present on the Sunshine Act at the 2013 PDMA Sharing Conference on September 29 in Baltimore, Maryland.  

Alan G. Minsk will be presenting "Walking the False Claims Act Compliance Line: A U.S. Regulatory Lawyer’s Perspective" at Informa Life Science's Summit in London, England on October 10, 2013. 


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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