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Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from colleagues in other related life science disciplines. 

In This Issue

Industry Insights

Honesty Is Hardly Ever Heard, And Mostly What FDA Needs From Your Firm: Handling a Regulatory Call or Meeting With FDA 

By: Alan G. Minsk & Robert Durkin 

From the 1978 52nd Street album, Billy Joel sings, “Honesty is such a lonely word, everyone is so untrue; honesty is hardly ever heard, and mostly what I need from you.” While we don’t want to start out this Bulletin on such a melancholy note, the lyrics have come to mind as we have had recent client regulatory calls with the Food and Drug Administration. Part of our day-to-day job is to help clients respond to FD-483s, Warning Letters, and other compliance and enforcement actions brought by FDA and similar regulatory bodies. At times, regulators, such as FDA, will request a meeting or — with the pandemic — a call. Depending on a number of factors, which we will discuss, this call or meeting can be a potential opportunity for the company to extricate itself from a near-fatal experience or it can, alas, accelerate the company into a likely consent decree or some other similarly devastating consequence. More >

Recent FDA Draft Guidance to Industry Offers Insight on “Content of Premarket Submissions for Device Software Functions”
By: Alan G. Minsk & Laura S. Dona  

Recently, the Food and Drug Administration issued a draft guidance, “Content of Premarket Submissions for Device Software Functions,” to help industry understand what it should include in regulatory marketing submissions to assist the agency in evaluating the safety and effectiveness of device software functions. The guidance applies to both software in a medical device (“SiMD”) and software as a medical device (“SaMD”). More >

Federal Court Rejects Bid to Declare Co-Pay Assistance Program Lawful
By: Jennifer D. Burgar W. Jerad Rissler  

The United States District Court for the Southern District of New York recently rejected Pfizer’s request for a declaration that its co-pay program would not violate the Anti-Kickback Statute (“AKS”). The case is Pfizer Inc. v. United States Department of Health and Human Services, Case No. 1:20-cv-04920-MKV (S.D.N.Y. Sept. 30, 2021). The case involved two separate co-pay assistance programs for tafamidis, a drug that treats Transthyretin Amyloid Cardiomyopathy (“ATTR-CM”), a rare, progressive condition that causes deposits of amyloid protein to be deposited in the heart muscle. More  

AGG Attorney Spotlight 



Kevin M. Bell is a partner and co-chair of the Dietary Supplements industry team and Intellectual Property practice, as well as a leader of the Patent practice and a member of the Litigation practice.

Kevin possesses a robust practice representing U.S. and international companies across a broad range of technologies that include biotech, pharmaceutical, medical device, dietary supplement, software, semi-conductor, and computer science-related matters. He has successfully implemented novel economic theories, resulting in substantial monetary damages awards for his clients at trial. He regularly represents clients in investigations and enforcement matters before agencies, such as FDA, FTC, DOJ, CBP, National Advertising Division (NAD) of the BBB, and state attorneys general.

A leading legal adviser in the areas of dietary supplements and natural products, Kevin is highly sought after by companies for his success in providing clients with global strategies to protect and enforce their intellectual property and execute complex, regulatory enforcement efforts in the U.S. and abroad. Kevin has also developed a significant presence in the areas of cannabis and CBDs, as it relates to regulatory, IP, and legislative issues.

Industry Recognition

24 AGG Practices Recognized in 2022 “Best Law Firms” Rankings

AGG is pleased to announce the firm’s rankings in the 2022 U.S. News – Best Lawyers “Best Law Firms” guide. AGG earned six national rankings and 24 metropolitan rankings, including 15 Tier 1 practice rankings. “Best Law Firms” are recognized for professional excellence based on clients and peer evaluations. To be eligible for a ranking, a law firm must have a lawyer listed in the 27th Edition of The Best Lawyers in America® guide, which recognizes the top four percent of practicing attorneys in the U.S. AGG has 68 lawyers recognized as “Best Lawyers” including Food & Drug practice team leader Alan G. Minsk who was recognized for the fourth year in a row for exceptional service in FDA Law. To view the press release, please click here.

Seminar Recording
2021 AGG Employment Law Seminar

On November 16, AGG’s Employment Law team hosted its annual Employment Law Seminar titled “The World Turned Upside Down: Vaccines, Vacancies, & Other Vexations in the Pandemic Workplace.” This virtual program took a deep dive into the most pressing workplace issues of the day, including government vaccine mandates, OSHA rules, and the challenges presented by the "Great Resignation," an increasingly virtual workforce, and special twists in state law. To view the recording, please click here.

Upcoming Webinars/Events

Honesty Is Hardly Ever Heard, and Mostly What FDA Needs From Your Firm: Handling a Regulatory Call or Meeting with FDA 

Please join Food & Drug practice team leader Alan G. Minsk and of counsel and former Acting and Deputy Director of FDA’s Office of Dietary Supplement Programs Robert Durkin for a complimentary webinar on December 16 from 12:00 PM – 1:00 PM EST on how pharmaceutical, biologic, medical device, and food companies can handle a regulatory call or meeting with the Food and Drug Administration. These meetings discuss compliance concerns, typically relating to quality-related issues that FDA perceives could possibly cause harm to consumers of the company’s FDA-regulated products. Depending on a number of factors, there may be a potential opportunity for the company to extricate itself from a near-fatal experience or it can accelerate the company into a likely enforcement action, such as a consent decree or some other similarly devastating consequence. For more information or to register, please click here.


Alan Minsk To Present "Quality Agreements and What You Should Know and Consider"

Alan G. Minsk will present "Quality Agreements and What You Should Know and Consider" at 7:00 AM EST on December 1 to a contract development and manufacturing organization. For more information about this event, please contact Alan.
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This newsletter is published by Arnall Golden Gregory’s Food & Drug and Government Affairs & 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 on the Food & Drug practice, please contact Alan G. Minsk.

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