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   May 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



DOJ Announces Settlements with Three Pharma Companies for Allegations of Co-Pay Assistance Kickbacks Through Conduit Foundations
By: Jennifer Downs Burgar and Genevieve M. Razick

On April 4, 2019, the Department of Justice (DOJ) announced settlements with three pharmaceutical companies, Jazz Pharmaceuticals plc (Jazz), Lundbeck LLC (Lundbeck), and Alexion Pharmaceuticals (Alexion), related to allegations that the companies made inappropriate payments to patient assistance programs (PAPs) administered by third parties that the companies used as conduits. PAPs provide financial assistance, often in the form of assistance with insurance co-payments, to patients with limited financial means. PAPs may be administered by foundations established by pharmaceutical companies or through independent charitable organizations. More >

CMS Finalizes Rule Requiring Prescription Drug Price Information in Direct-to-Consumer Television Advertisements
By: Seth S. Ray, Christine Kirk, and Genevieve M. Razick

On May 10, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule requiring that direct-to-consumer television advertisements for prescription drugs and biological products include certain pricing information for products covered under the Medicaid or Medicare programs. The final rule follows CMS’s proposed rule published on October 18, 2018. After considering public comments, the agency decided to publish the final rule largely as proposed, with one modification regarding state law preemption, and other smaller changes to improve clarity. The final rule will take effect on July 9, 2019. More >



FDA Has Not Gone Away When It Comes to Unlawful Medical Device Promotion: Companies Receive Warning Letters for Violative Promotional Claims
By: Alan G. Minsk, Christine Kirk, and Genevieve M. Razick

In April 2019, the Food and Drug Administration issued two Warning Letters to medical device manufacturers, reminding industry that the agency will take enforcement action against unlawful promotion when it sees fit. One Warning Letter addressed promotional claims and misleading statements provided in marketing materials, including promotion of an unapproved device. The other Warning Letter related to modifications to an in-vitro diagnostic (IVD) assay that resulted in adulteration and misbranding of the productMore >

Upcoming Events

AGG Partner Alan Minsk and AGG Of Counsel Seth Ray will present a complimentary webinar "FDA Programs To Expedite the Development and Review of Drugs and Biologics for Serious Conditions" on June 6th.  

AGG Partner Alan Minsk will present at the G&M Health's Compliance Conference on “Hub Service Program: Identify Compliance Risks and Develop a Plan to Protect Your Company” on June 13th in Bridgewater, NJ. This is an invitation only presentation.

AGG Partner Alan Minsk will present a webinar at the Regulatory Affairs Professional Society (RAPS) on "Virtual Program: US Regulation of Advertising, Promotion and Labeling for Drugs (2-part Series)" on June 27th.

AGG Partner Alan Minsk will present at the Q1 Production Life Science Advertising & Promotions Regulatory Affairs Conference on "Interpretation Of The Communications With Payors Guidance," July 23 - 24th in Arlington, VA.

Industry Activities and Recognition 

AGG Partner Alan Minsk and AGG’s Life Sciences Department were Recognized by Chambers USA 2019 Guide 
The newly released Chambers USA: America’s Leading Lawyers for Business 2019, recognized 20 Arnall Golden Gregory lawyers and eight practices. More >

AGG Partner Alan Minsk Presented at The Sharing Alliance's Short Course: Field Compliance Monitoring 
AGG Partner Alan Minsk presented 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” in New Jersey.

AGG Associate Christine Kirk Moderated an FDLI Annual Conference Table on Medical Device Developments  
AGG Associate Christine Kirk moderated a table topic discussion on medical device developments at the 2019 annual conference of the Food and Drug Law Institute (FDLI) in Washington, D.C.

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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