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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

Industry Insights

I Can’t Drive 55: The Law is the Law and FDA is the Enforcer
By: Alan G. Minsk and Robert Durkin

The Red Rocker, Sammy Hagar, sang in 1984, “I Can’t Drive 55.” When counseling clients at our Firm about the potential of enforcement risk by the Food and Drug Administration (or any other regulatory authority for that matter), we often use the speed limit analogy. Most companies will want to comply with applicable laws because “it is the law,” or non-compliance will cost them more money and time to fix the inevitable problems that will arise, or both. However, there are company executives who will, understandably for business reasons, ask about the potential for “risk” or the consequences if they choose not to follow the letter of the law. (This is typically followed by, “Of course, I want to do the right thing” and “I don’t want to go to jail.) More >

You Can't Say That on TV: FDA Issues an Untitled Letter for an Unlawful Television Ad
By: Alan G. Minsk and Seth S. Ray

The Food and Drug Administration’s Office of Prescription Drug Promotion isn’t letting the Dog Days of Summer stop it from taking action against what it perceives as unlawful marketing. In its first Untitled Letter of 2020 and second letter this year (a Warning Letter was issued in February), OPDP took exception to a television advertisement that it claimed made misleading statements about the drug product’s efficacy and minimized risk information. More >

Food for Thought: How to Keep Clinical Trials Going During the Pandemic
By: Jennifer D. Burgar, Alan G. Minsk, and Genevieve M. Razick

Over the past few months, several clients have alerted us to the delayed or discontinued status of their clinical trials due to the COVID-19 pandemic. Studies typically conducted in physicians’ offices, clinics, or hospitals have been paused as in-person visits to such sites abruptly stopped. Patients are no longer visiting (or visiting in a limited capacity) brick and mortar physicians’ offices and clinics for treatment or follow-up, and visits to hospitals have been curbed due to the pandemic. In March 2020, the Food and Drug Administration issued a guidance document to provide some parameters on the conduct of clinical trials during the pandemic, including amendments to protocol-specified procedures and adhering to protocol-mandated visits and laboratory/diagnostic testing. More >

Are You Ready for OTC Drug Reform? The 180 Day Deadline is Fast-Approaching
By: Carolina M. Wirth and Genevieve M. Razick

The Coronavirus Aid, Relief and Economic Security Act (the CARES Act) ushered in a wave of reforms to the Food and Drug Administration’s regulation of over-the-counter (OTC) drugs in the United States. We previously described these reforms in an article titled, It is Not All About the Coronavirus: The CARES Act Brings Long-Awaited Over-the-Counter (OTC) Monograph Reform. As the first significant update to the OTC regulatory scheme since FDA established the OTC Drug Review process in 1972, it is not surprising that the changes have resulted in a number of questions from clients regarding how to ensure compliance with FDA’s new OTC regulatory regime. This article serves as a reminder of a few key dates for some of the upcoming changes as the agency overhauls its OTC drug review process. More >

No Food for You: FDA Detention of Food
By: Alan G. Minsk and Robert Durkin 

Maybe it’s a product that you’ve imported into the U.S. dozens of times. Maybe this is your first time importing this product or you’re working with a new business partner. Maybe you’re very familiar with the process, or maybe this is your first attempt at it. It doesn’t matter, you’ve done your homework, made your plans, you’re ready for the next step and all you need is for the import to arrive. Then you get word: the import is ‘hung up at the border’ – detained – by the Federal Food and Drug Administration (FDA). Now what? More >

Upcoming Events

AGG Partner Alan Minsk to Speak at 2020 RAPS Convergence: “AdPromo: Same, Similar, or Superior Claims”      
Alan G. Minsk will be speaking at Regulatory Affairs Professionals Society (RAPS)’s virtual event: “2020 RAPS Convergence.” Joined by Jennifer Kelley, MS, RAC, Director of Global Regulatory Affairs at Sanofi, they will discuss CFL and generics/biosimilars promotion and provide commentary and examples to implement them at the “Ad/Promo: Same, Similar, or Superior Claims” webinar on September 15, 2020 at 1:00PM – 2:30PM EST. For more information or to register, please click here.


Robert Durkin Will Speak at FDLI’s Annual Conference’s Breakout Session: “Managing Recalls, Internal Investigations, and Brand Management”      
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 7th. 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.

Industry Activities and Recognition

AGG Food and Drug Practice Team Leader Recognized in Best Lawyers in America

Best Lawyers in America recently recognized AGG Food and Drug Practice Team Leader Alan G. Minsk in its 2021 listing. Alan focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, food (including dietary supplements and medical foods) companies, on all legal and regulatory matters relating to the U.S. Food and Drug Administration. To learn more about Alan and his practices, please click here. To view the full press release or the complete 2021 AGG attorneys listing, please click here.

AGG Attorneys Kevin Bell and Robert Durkin Quoted in “FDA, Supplement Manufacturer Debate NDI Import Alert Request”

AGG attorneys Kevin M. Bell and Robert Durkin were both quoted in Natural Products Insider’s article: “FDA, Supplement Manufacturer Debate NDI Import Alert Request.” Kevin and Bob discussed their request to issue an import alert to stop adulterated beta-alanine ingredients produced in China from entering the United States. To read the full article, please click here.
AGG Attorney Robert Durkin Quoted in “FDA Warning Letters on NAC Cause Stir in Supplement Sector”
Robert Durkin, former deputy director of ODSP, now of counsel of AGG’s Dietary Supplements industry team, was quoted in Natural Products Insider’s article: “FDA Warning Letters on NAC Cause Stir in Supplement Sector.” Bob commented on the review process of structure/function (S/F) and the legality of NAC in dietary supplements. To read the full article, please click here.


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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