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Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice. We are thinking of all of you in these difficult times, and hope all of you and your loved ones are safe.

In This Issue

Podcast: I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues

AGG is proud to introduce our newest podcast series titled "I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues." Each month, we'll release a new podcast where different members of our Food and Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal issues. In our inaugural episode, Alan G. Minsk, partner and leader of the Food & Drug practice team, is joined by Michael E. Burke, co-chair of the Pharmaceuticals & Biologics industry team, and the administrative partner of the firm’s D.C. office as they discuss issues around quality agreements for FDA regulated products as well as topics related to manufacturing, FDA timelines and compliance with relevant national authorities. To listen to the podcast, please click here.

Stay tuned for more from AGG's Food & Drug team in this channel.

Industry Insights

Don’t Tune Out OPDP’s Recent Warning Letter For a Violative Radio Advertisement
By: Alan G. Minsk and Genevieve M. Razick

On August 31, 2020, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent a Warning Letter to the sponsor of a drug for a violative direct-to-consumer (DTC) radio advertisement.1 The radio advertisement was submitted to FDA under the cover of FDA Form 2253. According to OPDP, the sponsor’s radio advertisement made false or misleading claims about the risks associated with the prescription drug product and omitted other material facts. Thus, the radio advertisement misbranded the drug within the meaning of the Federal Food, Drug, and Cosmetic Act. We will summarize OPDP’s concerns with the radio advertisement. More >

Houston, We Have A Problem: FDA Confirms That It Will Only Conduct Mission-Critical Inspections and Prioritized Domestic Inspections of Drug and Biological Product Manufacturers During the COVID-19 Pandemic
By: Carolina M. Wirth

In March 2020, FDA temporarily postponed all domestic and foreign routine surveillance facility inspections, as well as surveillance inspections in support of the Bioresearch Monitoring (BIMO) program. Four months later, in July 2020, the agency announced that it was beginning to work toward resuming “prioritized domestic inspections” using its COVID-19 Advisory Rating system to determine the types of regulatory activity that could take place in a given geographic region. FDA determined that it would continue, on a “case-by-case basis, to conduct only “mission-critical” inspections or where possible to do so safely, resuming prioritized domestic inspections, which generally include pre-approval and surveillance inspections.” FDA also announced that prioritized domestic inspections would be pre-announced to FDA-regulated businesses for the foreseeable future. More >

FDA Issues Proposed Rule Seeking to Clarify Evidence Relevant to Its Intended Use Determinations of FDA-Regulated Products
By: Robert Durkin and Seth S. Ray

On September 23, 2020, the U.S. Food and Drug Administration (FDA) published in the Federal Register a proposed rule titled, “Regulations Regarding ‘Intended Uses.’” The goal of this proposed rule is to amend the regulations defining “intended use” – for drugs and medical devices to provide better clarity regarding the specific types of evidence the agency may rely on when making a determination about the intended use of these FDA-regulated products. More >

President Donald Trump Signs an Executive Order Aimed at Lowering Medicare Drug Prices
By: Neil W. Hoffman and Genevieve M. Razick

On September 13, 2020, President Donald Trump issued an Executive Order, “Lowering Drug Prices by Putting America First,” to direct the Secretary of Health and Human Services (HHS) to implement new payment models under Medicare Parts B and D to curb “unfair” and high drug prices in the United States. Under the Executive Order, the Medicare program would not pay more for Part B or Part D prescription drugs or biological products than the “most-favored-nation price.” More >

Upcoming Events

Robert Durkin to Speak at FDLI’s Annual Conference on October 7      

Invited by Food and Drug Law Institute, AGG attorney Robert Durkin will be speaking at FDLI’s Annual Conference: Exploring Advanced Topics in Food and Drug Law on October 7. Robert, along with other panelists, will be speaking at “Managing Recalls, Internal Investigations, and Brand Managements,” one of FDLI’s breakout sessions. They will discuss recent recall trends, FDA’s new recall guidelines, and PR best practices for crisis management. For more information or to register, please click here.
Alan Minsk to Speak at The Sharing Alliance Annual Conference on October 21     
Joined by Jennifer Valentine from MedPro Systems, AGG partner and team leader of the Food & Drug Team Alan G. Minsk will speak on “Even More Drug Distribution Challenges – Florida and Ohio” workshop on October 21 from 2:30 PM to 3:30 PM at The Sharing Alliance Annual Conference. For more information or to register, please click here.
Carolina Wirth to Present “OTC Drug Reform & the CARES Act (Monographs & OMUFA)” Webinar at FDAnews on October 21  
Join AGG attorney Carolina M. Wirth for a complimentary webinar on “OTC Drug Reform & the CARES Act (Monographs & OMUFA),” hosted by FDAnews and sponsored by Reed Tech, on October 21 at 11:00 AM. Carolina, alongside Gary Saner, medical device identification expert, will both discuss FDA’s OTC monograph reform, OMUFA and the CARES Act, suggested best practices, and opportunities for innovation. For more information or to register, please click here
Carolina Wirth to Moderate FDLI’s “Social Media Platform Advertising Considerations” Panel on October 29
AGG attorney Carolina M. Wirth will moderate a panel, titled “Social Media Platform Advertising Considerations," which will be presented by Eric DeLange, Senior Manager of Government & Health at Snapchat on October 29 at FDLI’s Advertising and Promotion for Medical Products Conference. For more information or to register, please click here.
Industry Activities and Recognition

Kevin Bell and Robert Durkin Quoted in Article Titled “FDA Leaves Open Possibility of NDI Enforcement Against Chinese-Produced Beta-Alanine”

AGG attorneys Kevin M. Bell and Robert Durkin were both quoted in Natural Products Insider’s final installation in a four-part series of articles on FDA enforcement of the new dietary ingredient notification requirement on September 29. To read the full article, please click here.


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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.

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