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 Food and Drug Newsletter    

July 11, 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:

  • FDA Publishes Final Rule on Orphan Drug Exclusivity
  • Chinese Authorities Detain a Global Pharmaceutical Company’s Employees for Bribery
  • US Supreme Court Rules that "Reverse Payment" Settlements Are Not Immune from Antitrust Review
  • FDA Proposes New Cybersecurity Submission Standards for Medical Devices
  • FDA Draft Guidance Clarifies Medical Device Reporting for Manufacturers
  • What Kind of Food am I? Medical Food History, Enforcement and Future
  • Expect More Nutritional Labeling for Alcoholic Beverages
  • Bills Establishing a National Prescription Drug Tracking System Gain Momentum
  • Industry Activities and Recognition
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       Industry Insights
       

      Pharmaceuticals

      FDA Publishes Final Rule on Orphan Drug Exclusivity
      By: Clark G. SullivanEmalee G. Murphy, and Sari Bourne

      In June, the Food and Drug Administration issued a final rule amending the Orphan Drug regulations. This bulletin highlights some of the major points described in the final rule. More >

      Chinese Authorities Detain a Global Pharmaceutical Company’s Employees for Bribery
      By: Michael E. Burke, Emalee G. Murphy, and Sari Bourne

      A growing number of global pharmaceutical and medical device companies are facing bribery and corruption accusations in emerging markets such as China and India. This issue most recently came to light in early July, when Chinese officials allegedly detained several employees of a large global pharmaceutical company. More >

      US Supreme Court Rules that "Reverse Payment" Settlements Are Not Immune from Antitrust Review
      By: Jeffrey S. Jacobovitz

      On June 17, 2013, the US Supreme Court ruled in the case of FTC v. Actavis, 570 U.S. ___ (2013), that “reverse payment” settlement agreements—where they are large and unjustified—may violate the antitrust statutes. This article discussed the Supreme Court’s decision and its implications for future Hatch Waxman lawsuits. More >

       

       
        
       

      Medical Devices

      FDA Proposes New Cybersecurity Submission Standards for Medical Devices 
      By: Emalee G. Murphy and Sari Bourne

      On June 14, 2013, the Food and Drug Administration issued a draft guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” aimed at reducing the risks of unauthorized use of information stored on medical devices. More >

      FDA Draft Guidance Clarifies Medical Device Reporting for Manufacturers 
      By: Emalee G. Murphy

      Medical device manufacturers puzzling over FDA reporting and recordkeeping requirements, the draft guidance issued on July 11, 2013 will come as a welcome insight into FDA’s current thinking on this issue and some practical advice for completing medical device reports (MDR) submitted to the agency in regard to certain device-related adverse events. More >

       
       
       

      Food

      What Kind of Food am I? Medical Food History, Enforcement and Future
      By: Emalee G. Murphy

      Medical foods are a growing segment of the food industry; an estimated $8 billion worth was sold world-wide in 2011, $2 billion of which represents U.S. sales. Industry watchers expect continued growth in this niche food category as the U.S. population ages. Key factors in that growth are the Food and Drug Administration’s (FDA) lighter regulatory supervision and the ability to market medical foods for use in managing specific diseases. So what are medical foods and what are the FDA rules that govern their successful existence? More >

      Expect More Nutritional Labeling for Alcoholic Beverages
      By: Emalee G. Murphy and Sari Bourne

      Wine, beer, and spirits companies that want to label or advertise the nutritional content of their products have new guidance in an interim Ruling from the Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau (TTB). The 2013 Ruling, published at the end of May, permits companies to format the voluntary nutrition content using a Serving Facts statement on beer, wine, or distilled spirit labels and eliminates new label approval for existing labels that follow the Ruling requirements. More >

       
       

      Legislative Update from Capitol Hill

      Bills Establishing a National Drug Tracking System Gain Momentum
      Clark G. Sullivan, Emalee G. Murphy, Sari Bourne, and Kim Phan

      In June, the U.S. House of Representatives passed a bipartisan bill that would amend the Federal Food, Drug, and Cosmetic Act to create a national system for tracking prescription drugs throughout the supply chain. The bill is now being considered by the Senate, which is also considering another similar bill. More >



      Industry Activities and Recognition
       

       

      Alan Minsk Listed in The International Who's Who of Business Lawyers

      Alan G. Minsk is listed in the 2013 edition of The International Who's Who of Business Lawyers, Life Sciences – Regulatory.




      Sari Bourne Appointed to American Bar Association Leadership Position

      Sari Bourne was recently appointed as the Vice-Chair of the International Life Sciences and Health Law Committee and as a member of the Steering Group for the Middle East Committee of the ABA Section of International Law for 2013-2014.


      AGG Assists Pharmaceutical Company Client with Regulatory Opinion Letter for IPO

      AGG provided an FDA Regulatory Opinion Letter for an Israeli pharmaceutical company's recent initial public offering.  The letter assured the underwriters that the company is FDA compliant and that the offering can proceed. Primary AGG attorneys involved were Alan G. Minsk, William H. Kitchens, and Robert F. Dow.

       
      This newsletter is published by the 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.
       
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