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  March 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



Fight the Good Fight Every Moment: Do Recent First Amendment Court Developments Deal a Blow to the Government? 
Alan G. Minsk

In the last month, the Food and Drug Administration has suffered setbacks relating to off-label promotion oversight. In both cases, one involving a pharmaceutical company and the other a medical device firm and its Chief Executive Officer, the government’s attempt to take enforcement action against dissemination of off-label information was blocked as violating the First Amendment, taking a page from Triumph’s 1981 classic rock song, “Fight the Good Fight.” More >



Justice Department Announces Largest Settlement Ever For Violations Of The Anti-Kickback Statute By A Medical Device Company
Sara M. Lord

On March 1, 2016, the United States Department of Justice (DOJ) announced that Olympus Corp. of the Americas (OCA), the nation’s largest distributor of endoscopes and related equipment, had agreed to pay $623.2 million to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals. A subsidiary of the company, Olympus Latin America, Inc. (OLA), will pay another $22.8 million to resolve criminal charges relating to the Foreign Corrupt Practices Act (FCPA) in Latin America. The settlement, which has been billed as the largest total amount paid in U.S. history for violations involving the AKS by a medical device company, includes several components. More >

Telehealth and Medicare: MedPAC Presents Updated Research to the Commission
By: Andrew B. Flake and Barbara J. Rogers 

The status of expanded federal telehealth reimbursement remains uncertain. Continuing an ongoing national policy conversation, the Medicare Payment Advisory Commission (MedPAC) held its second meeting on March 3, 2016, under the title “Telehealth Services and the Medicare Program.” MedPAC previously met in November 2015 to discuss this topic after the commission expressed interest in learning more about “the extent to which telehealth is used within the Medicare program and outside the program.” Although the March meeting updated previously presented research, MedPAC again concluded that “evidence of efficacy of telehealth services is mixed.” More >



New EU/US Privacy Shield Details Announced Program Includes Provisions for Pharmaceutical and Medical Products
By: Kevin Coy

On February 29th, the European Commission (the “Commission”) published the details of the new EU/US Privacy Shield program (“Privacy Shield”) which is intended to replace the EU/US Safe Harbor (“Safe Harbor”) program that was found to be inadequate by the European Court of Justice (“ECJ”) in October. The Commission also released a draft opinion which, if adopted, would find the new Privacy Shield to be an adequate means of transferring personal data from the EU to companies in the US that elect to participate in the new program. The Privacy Shield will not become effective until the final approval of the Commission’s adequacy determination, which is not expected for several months. More >

Big Data Analytics Under HIPAA
By: Kevin Coy and Neil W. Hoffman, Ph.D.

Such privacy laws and regulations as the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule can have a significant impact on the development of health care data analytics in cases where those analytics rely upon, or are developed using, HIPAA-regulated protected health information. Data analytics, also referred to as “big data” when done on a large scale, are often viewed as having the potential of transforming health care, enabling providers to use population data in identifying and preventing diseases, developing treatments, and reducing costs of health care. As recently noted by the Privacy and Security Workgroup (PSWG), benefits of data analytics could include “safer treatments, the ability to target communities and individuals with tailored interventions, and the ability to respond to the spread of diseases more rapidly.” More >

Industry Activities and Recognition 

AGG Partners Quoted Regarding Recent FDA/FTC Webinar
AGG Partners Anuj Desai and Alan G. Minsk were recently quoted in an article by The Gray Sheet regarding the importance of native advertising, which they discussed during a recent webinar entitled "For Native Advertising, FDA/FTC Rules Still Apply, Attorneys Stress". More >

AGG Partner Reappointed as General Counsel of PDMA Alliance, Inc.
AGG Partner 
Alan G. Minsk was recently reappointed to serve as the General Counsel of the PDMA Alliance, Inc. The PDMA Alliance, Inc. is a non-profit pharmaceutical industry organization made up of compliance professionals, focused on improving the understanding of the Prescription Drug Marketing Act (PDMA) and other laws and regulations governing pharmaceutical samples, and improving the efficiency and effectiveness of sample accountability programs. More >

Upcoming Events 

AGG Attorneys Alan G. Minsk and Kelley C. Nduom will present a complimentary webinar "Off-Label Promotion: A Crystal Ball Look at Possible Effects of Recent Developments in This Ever-Evolving Area" on March 30, 2016.

AGG Partners Anuj Desai and Alan G. Minsk will present the webinar "Native Advertising - How Life Science Companies Can Keep the FTC and FDA Happy" on March 31, 2016.

AGG Partner Alan G. Minsk will moderate and present on "The Current and Future Priorities for CDER and the Impact of Those Priorities" at the 2016 FDLI Annual Conference in Washington, DC on May 5, 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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