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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

PhRMA Code Changes Are on the Horizon: Is Your Company-Sponsored Speaker Program Ready?
By: Jennifer D. Burgar & Genevieve M. Razick 

In August 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced an updated and enhanced PhRMA Code on Interactions with Healthcare Professionals (PhRMA Code). The revisions apply to the PhRMA Code’s principles applicable to company-sponsored speaker programs. The changes will go into effect on January 1, 2022. More

What You Need to Know: Mitigating Risk During A Medtech Deal
By: Lori L. Wright & Eunice C. Lim  

Over the past decade, M&A activity has been steadily trending upward, paused only momentarily in 2020 by global pandemic concerns. Although activity is heavy across many sectors, there is particular interest and investment in medical technology (“medtech”). Despite the pandemic, in 2020, over 100 medical tech M&A deals were closed worldwide. Although the FDA’s regulatory reach extends only to medical devices, in recent public comments, FDA officials have signaled an interest in increasing their enforcement abilities to include software that does not meet the definition of a device, but which supports or is relied on by devices. These overtures, paired with increased national attention on cybersecurity and resiliency, give rise to unique and constantly evolving legal concerns. More 

A Shot in the Arm: New Biden Administration Rules Mandate Vaccinations or Frequent Testing In Numerous Employment Settings 
By: Henry M. Perlowski & Thomas E. Kelly 

On September 9, 2021, President Biden announced a sweeping action plan to address the ongoing COVID-19 pandemic in the United States, entitled The Path Out of the Pandemic. This plan is based on six pillars identified by the Biden Administration as critical to combating the COVID-19 pandemic, including: i) federal vaccination and testing mandates applicable to both public and private sector employees; ii) booster shots for the vaccinated population; iii) increased testing and masking requirements; iv) facilitation of further economic recovery; v) ensuring that schools remain open; and vi) improving care for those impacted by the COVID-19 virus. More >

Podcast: I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues
Episode 8: Business Divorces in the Food and Supplements Space

In this episode, Michael E. Burke, partner and co-chair of the Pharmaceutical & Biotechnology industry team is joined by Robert Durkin, an attorney in our Dietary Supplements team, as they discuss issues around business divorces or disputes between companies in the food and supplements space. They will discuss, among other things, post-divorce product regulatory status and related business challenges, as well as strategies that can be employed at the beginning of the business relationship to help mitigate risk if the relationship goes bad. To listen to the podcast, please click here.

Industry Activities and Recognition




AGG Adds High-Stakes Litigator, Prominent Healthcare Attorney to its Washington, D.C., Office 

Arnall Golden Gregory is pleased to announce that litigation attorneys Matthew M. Lavin (top) and Aaron R. Modiano (bottom) joined the firm’s Healthcare practice in its Washington, D.C. office. Matt joins the firm as a partner with a leading healthcare litigation practice focused on provider-side reimbursement matters. As an attorney and former executive with a national network of clinical facilities, Matt has significant experience working with healthcare providers in reimbursement matters, payer relationships, audits, assignments, third-party repricing, marketing, finance, governance, government relations, regulatory compliance, and licensing. Aaron joins the firm as of counsel who works routinely with Matt representing clients in healthcare litigation and other complex litigation matters. Aaron is also experienced in ERISA claims, RICO litigation, insurance unfair business practices and bad faith matters, environmental law and plaintiff’s mass tort litigation. To view the press release of Matt and Aaron's arrival, please click here.


Kevin Bell Quoted in NutraIngredients Article Titled “Lawyer: FDA’s Ongoing Refusal To Act on CBD Impacts Trademark Laws”

AGG partner and Dietary Supplements team leader, Kevin Bell, was quoted in a NutraIngredients article titled “Lawyer: FDA’s Ongoing Refusal To Act on CBD Impacts Trademark Laws” on September 22, 2021. For more information, please click here.

Robert Durkin Quoted in FoodNavigator Article Titled “’The FDA Has Been Absent Without Leave on This Issue…’ Congressman Raja Krishnamoorthi on Heavy Metals in Baby Food”
AGG attorney and member of the firm’s Dietary Supplements industry team, Robert Durkin, was quoted in an article by FoodNavigator titled “’The FDA Has Been Absent Without Leave on This Issue…’ Congressman Raja Krishnamoorthi on Heavy Metals in Baby Food” on September 8, 2021. For more information, please click here.

Robert Durkin Quoted in a POLITICO Article on AgencyIQ Titled “The FDA’s Most Frequent Safety Concerns for New Dietary Ingredient Submissions”

Robert Durkin was quoted in a POLITICO article featured on AgencyIQ titled “The FDA’s Most Frequent Safety Concerns for New Dietary Ingredient Submissions” on September 7, 2021. A subscription is required to view the article. For more information, please click here.
Upcoming Webinar

And Now There Are Three: A Look at the New California, Colorado and Virginia Privacy Statutes From a Life Science Company Perspective

On October 12, 2021 from 1:00 PM – 2:00 PM EDT, please join partner and Food and Drug team leader Alan G. Minsk, partner and co-chair of the Data Privacy practice Kevin L. Coy, and associate in the Data Privacy practice Erin E. Doyle for a complimentary webinar as they discuss new privacy legislation in Colorado, the Colorado Privacy Act, and how it compares to the California Consumer Privacy Act, the California Privacy Rights Act, and the Virginia Consumer Data Protection Act. For more information or to register, please click here.
Upcoming Events
Robert Durkin To Present at the University of Nebraska-Lincoln’s Inaugural Agriculture & Health Summit
Robert Durkin will be joining the University of Nebraska-Lincoln's inaugural Agriculture & Health Summit for a panel discussion on October 12. The session will focus on substantiation, standardization, and the regulatory space for foods. For more information on this event, please click here.

Alan Minsk Joins BSI and Israeli Ministry of Health for Roundtable on the Regulatory Perspective of Digital Health at the 2nd Medical Device Research & Development Summit 

Alan G. Minsk will be joining BIS and the Israeli Ministry of Health for a roundtable discussion on the topic “Digital Health: Regulatory Perspective” in Tel-Aviv, Israel, on October 25, 2021, at the 2nd Medical Device Research & Development Summit. This year’s conference will focus on the development of artificial intelligence-based medical devices and the R&D methodologies and their linkage to product development and regulations. For more information about this event, please click here.
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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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