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   April 2019

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



Recent Third Circuit Case Will Impact FTC Enforcement in the Pharmaceutical Space and Beyond: FTC v. ShireViroPharma, Inc.
By: Jeffrey S. Jacobovitz and Christine Kirk

On February 25, 2019, the Third Circuit Court of Appeals issued a significant decision that will likely affect the scope, timing, and venue of future enforcement actions initiated by the U.S. Federal Trade Commission (FTC). In the case of FTC v. ShireViroPharma, Inc. (“Shire” or “Company”), the Court not only found for the defendant in the particular case at issue, but also made findings that may affect future FTC actions, particularly its holding regarding the “about to violate the law” standard in Section 13(b) of the FTC Act. Below, we provide a brief summary of the key holdings and potential implications of the case. More >



FDA’s Steps Toward a New Review Framework for Medical
Devices That Use Artificial Intelligence Algorithms 
By: Alan G. Minsk and Genevieve M. Razick

On April 2, 2019, the Food and Drug Administration issued a statement by Commissioner Scott Gottlieb on steps toward a new review framework specifically tailored to promote the development of medical devices that use artificial intelligence algorithms. The statement announced that FDA released a discussion paper and request for feedback, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD), as a first step toward developing a new and tailored approach to help innovators and developers to bring artificial intelligence devices to market. The paper is for discussion purposes only and not meant as a draft guidance for industryMore >

U.S. Senate Finance Committee Chairman and Ranking Member Write to HHS-OIG Regarding Physician-Owned Distributorships' Potential Failures Under the Physician Payment Sunshine Act”
By: Jennifer Downs Burgar and Genevieve M. Razick 

In a letter dated March 19, 2019, U.S. Senate Finance Committee Chairman Chuck Grassley of Iowa and Ranking Member Ron Wyden of Oregon wrote to the Department of Health and Human Services Office of Inspector General regarding potential failures of physician-owned distributorships (PODs) to disclose physician ownership or investment interests under the Physician Payment Sunshine Act. The Physician Payment Sunshine Act requires group purchasing organizations, including PODs (which are arrangements in which a physician purchases ownership interests in an entity that sells implantable medical devices for use in the physician’s surgeries), to report ownership or investment interests to the Centers for Medicare and Medicaid Services. More >

 Industry Activities and Recognition

AGG Partner Alan Minsk presented at the 43rd International Good Manufacturing Practice Conference 
AGG Partner Alan Minsk presented at the 43rd International Good Manufacturing Practice Conference on medical device promotion at the University of Georgia in Atlanta, GA.  

AGG Associate Christine Kirk presented a FDANews Webinar on OTC Regulation: Latest Developments and Best Practices 
On March 18, AGG Associate Christine Kirk discussed the pending OTC monograph legislation in Congress that could result in significant changes in the OTC space, and key compliance topics.

Upcoming Events 

AGG Associates Christine Kirk and Genevieve Razick will present at a Food and Drug Law Institute program for the Centers for Disease Control and Prevention on April 23, 2019, in Atlanta, Georgia. The session will cover FDA’s organizational structure and background and various sources of law from which FDA derives its regulatory authority. The presentation is not open to the public.

AGG Partner Brooke Dickerson and AGG Of Counsel Jennifer Hilliard will present a complimentary webinar "Are You Ready? The Clock is Ticking to Comply with New EPA Hazardous Waste Pharmaceuticals Rule" on May 2, 2019.

AGG Partner Alan Minsk will present at The Sharing Alliance™’s Short Course: Field Compliance Monitoring on the topic of “Laws, Laws, and More Laws: an Overview of the Laws that Affect your Ride-along and Speaker Program Monitoring Plans” on May 1 in New Jersey.

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.
©2019. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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