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  September 2015

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



It's Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case
By: Alan G. Minsk 

To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off its recent loss in the Amarin court decision concerning off-label promotion, the agency again finds itself the defendant in another similar lawsuit concerning whether FDA can silence a company’s truthful and non-misleading communications about off-label uses. This time, it is Pacira Pharmaceuticals, Inc. challenging FDA’s authority. Perhaps not surprisingly, Pacira brought its challenge in the United States District Court for the Southern District of New York, the same forum where FDA lost the Amarin case, hoping for a similar result. More >

Compensation to Human Clinical Study Participants: A (Very) Informal Survey
Alan G. Minsk

At least once a month, life science clients contact us about best practices on a particular topic or to benchmark a proposed activity against what others in the industry might be doing. One such request, concerning compensation to clinical trial subjects, came up recently that we thought we would share. While our informal survey is not scientifically sound, it offers some insight as to norms. More >

Antitrust Implication of Recent FTC Patent Related Agreement
By: Jeffrey S. Jacobovitz and Eric D. Olson

In recent years, the Federal Trade Commission (FTC) has refocused its efforts on the interplay between the patent system and antitrust law, particularly in the pharmaceutical industry. While most of this focus has manifested in actions focused on so-called “pay-for-delay” settlements that prolong a brand name pharmaceutical product’s market power, such as its victory in FTC v. Actavis, 133 S. Ct. 2223 (2013), the FTC has also focused on the interplay between marketers of generic products. More >



FDA Detects That a Screening Tool for Early Detection of Cancer Types Might Require Sleuthing
By: Alan G. Minsk and William H. Kitchens 

The Food and Drug Administration recently issued an untitled letter to a medical device company concerning its non-invasive blood test intended for use as a screening tool for the early detection of certain cancer types . FDA said that the product, sold direct-to-consumers, "appears to meet the definition of a device," and recommends the company consult with the agency about potential next steps. This is not the first time FDA has taken exception to such DTC screening tools.
More >



Update: The 21st Century Cures Act
By: Alan K. Parver and Leah Mendelsohn Stone 

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act, which modifies Food and Drug Administration processes, provides funding for the FDA and the National Institutes of Health, includes provisions related to the interoperability of health information technology and modifies certain Medicare and Medicaid coverage and reimbursement requirements. It is anticipated that the Senate will consider its version of the bill, the Innovation for Healthier Americans initiative, when it reconvenes after Labor Day.
More >

Hospitals Accused of Violating the False Claims Act Through Ownership of the PPO For Their Self-Funded Employee Health Plans
By: Sara M. Lord 

On August 27, 2015, following notification by the government that it had decided not to intervene, the United States District Court for the Middle District of North Carolina, ordered that a qui tam complaint charging Carolinas Medical Center (CMC) and N.C. Baptist Hospital (Baptist) with violating the False Claims Act (FCA) be unsealed. The complaint, which was originally filed in June 2009, accuses the hospital groups of violating the FCA based on their co-ownership of MedCost, a managed care company that was the Preferred Provider Organization (PPO) and Third Party Administrator (TPA) for their respective self-funded employee health plans.
More >

Industry Activities and Recognition 

AGG Attorneys Presented to the Oley Foundation

Alan K. Parver and Leah Mendelsohn Stone conducted a webinar for the Oley Foundation. They provided an update on issues impacting home nutrition support policies, and discussed patient advocacy, the Medicare Home Infusion Site of Care Act, the Food and Drug Administration’s regulation of drug compounding, and new health care delivery models.

AGG Partner Presented on Food Safety Modernization Act at Logistics and Transportation Association of North America Annual Symposium 2015

William H. Kitchens spoke on “The Impact of the Food Safety Modernization Act on Food Transportation” at the Logistics and Transportation Association of North America Annual Symposium 2015 in Atlanta, Georgia on September 25, 2015. Mr. Kitchens discussed why the Food Safety Modernization Act represents a paradigm shift in food safety and recommended actions transportation and logistics companies should take to comply with new requirements affecting the transport of food.

Upcoming Events 

AGG's 2015 Annual Employment Law Seminar “Create a Winning Playbook: Learn Strategies to Prepare Your Workforce for the Changing Rules of the Game” in Atlanta, GA on October 8, 2015.

AGG Partner Alan G. Minsk will present “(Some) Issues to Consider with Medical Device Promotion” at the RAPS Annual Conference in Baltimore, MD on October 25, 2015.

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.
©2015. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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