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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

In today’s podcast entitled “Pandemic Marketing 101: Do's & Don'ts to Market Your Brands, Products, and Services Safely,” AGG partner Anuj Desai and of counsel Carolina M. Wirth discuss the Federal Trade Commission (FTC) and Food and Drug Administration's (FDA) roles of protecting consumers at the height of a public health crisis and the types of advertising and legal compliance issues that have surfaced in the past several months as well as provide a recap of agency actions. To listen to the episode, please click here.

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. To listen to previous episodes, please click here.

Industry Insights

Ain’t No Sunshine When the Government Comes: The DOJ and OIG Enforce the Sunshine Act
By: Alan G. Minsk and Rebekah N. Plowman

Recently, the United States Department of Justice and the Department of Health and Human Services’ Office of Inspector General entered into a Settlement Agreement with a medical drug company that caught our eye because of the reference to the Open Payments Program, i.e., the Sunshine Act. While the Settlement’s focus is on the company’s violation of the Anti-Kickback and False Claims Act statutes, this is the first time, of which we are aware, that the government is enforcing the Sunshine Act requirements. More >

Will the Next Therapeutic Emergency Use Authorization be for a Vaccine? FDA Announces Additional Steps to Increase Emergency Use Authorization Transparency
By: Carolina M. Wirth

As Coronavirus cases continue to spike all over the country, two vaccine companies have announced promising early results for their respective products. On November 9, 2020, Pfizer Inc. and BioNTech SE announced that their vaccine candidate against COVID-19 was “found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection . . . “ At the same time, they also announced that a submission for an Emergency Use Authorization (EUA) to the Food and Drug Administration was planned for after “the required safety milestone is achieved, which is currently expected to occur in the third week of November.” Only a week after Pfizer’s announcement, Moderna, Inc. also announced that its COVID-19 vaccine met its primary efficacy endpoint in the first Interim Analysis of the Phase 3 study data, showing that the vaccine is 94.5% effective. The company noted in its press release that it intended to submit for an EUA with FDA in the coming weeks and that it “expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months.” More >

The OIG Says There is No Such Thing as a Free Meal
By: Alan G. MinskRebekah N. Plowman and Mary Grace Griffin

On November 16, 2020, the Office of the Inspector General of the Department of Health Human Services issued a Special Fraud Alert: Speaker Programs (“Alert”), highlighting the fraud and abuse risks associated with speaker programs sponsored by pharmaceutical and medical device companies. To use its own word, the OIG is “skeptical” of the value of many speaker programs, which it believes may violate the Anti-Kickback Statute (AKS) by paying “substantial remuneration” to health care providers (HCPs) that are designed to encourage the HCPs to prescribe or use the sponsoring-company’s products, not because the products may benefit specific patients, but rather merely because they are paid. More >

Warnings of Ransomware Activity Targeting the Healthcare Sector and Potential Sanctions for Making Ransomware Payments
By: Kevin Coy

On October 28, 2020, the Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of Investigation (FBI), and the Department of Health and Human Services (HHS) issued a Joint Cybersecurity Advisory stating they have “credible information of an increased and imminent cybercrime threat to U.S. hospitals and healthcare providers.” The advisory pays particular attention to TrickBot, BazarLoader, and Ryuk ransomware and includes tips for detecting these forms of ransomware as well as user awareness tips. More >

Voters Approve the California Privacy Rights Act, Expanding California’s Data Privacy Law
By: Kevin Coy

California ballot initiative, Proposition 24, has passed. Less than a year after the California Consumer Privacy Act (CCPA) took effect, Californians voted on November 3rd to approve the California Privacy Rights Act (CPRA) which will amend and expand the CCPA. The CPRA, sometimes referred to as “CCPA 2.0,” will take effect on January 1, 2023, with an enforcement start date of July 1, 2023; but its new requirements will apply to personal information collected on or after January 1, 2022. More >

Be Careful to Not Beat Yourself in the Race To Market and Wind Up Excluding Your Own Ingredient From Being Allowed in Food or Dietary Supplements
By: Robert Durkin

We are often approached by clients interested in conducting studies relating to an article that qualifies as a dietary substance or ingredient. These clients also may be interested in substantiating claims they currently make for products that include the ingredient or for making new claims. Other times, clients are just beginning the process of introducing an ingredient to the market and are looking for guidance concerning the early stages of product development, including any studies they might require. However, these clients are sometimes surprised to learn that studying an ingredient as a drug may have already precluded it from being lawfully included in a food or product labeled as a “dietary supplement” under the Food, Drug, and Cosmetics Act (the “Act”). Two separate sections of the Act works to prohibit the use of a substance in a food, including dietary supplements, if certain circumstances are met. More >

Predicting White Collar Enforcement Priorities in the Biden Administration
By: Tenley A. Carp, Aaron M. Danzig, Brooke F. Dickerson, Jeffrey S. Jacobovitz, Sara M. Lord,
Alan G. Minsk, Adriaen M. Morse Jr., Rebekah N. Plowman, and John P. Rowley III 

As all signs point to Joe Biden becoming the 46th President of the United States, AGG has begun considering the likely shifts in white collar enforcement from the Trump Administration to a Biden Administration. Every administration brings its own priorities to enforcement, with the Trump Administration focusing more on immigration and corporate espionage cases, while conventional wisdom holds that Democratic administrations emphasize white collar enforcement and a more active regulatory environment. We anticipate that a Biden Administration will actively renew and initiate criminal and enforcement investigations in a number of areas where the Trump Administration was not as active. More >


Upcoming Events

Robert Durkin to Present and Moderate at “The Big Natural”       

AGG attorney Robert Durkin is scheduled to present product claims and moderate “Regulatory Hurdles for Probiotics” at “The Big Natural,” Natural Products Association’s annual conference from November 30 to December 1, 2020. “The Big Natural” is a two-day educated session that offer case studies, interactive discussions, and networking events for industry leaders. For more information about Bob’s presentations at “The Big Natural,” please click here. To register or to learn more about the event, please click here.
Alan Minsk to Present “Drug, Biologics, and Combination Products Labeling: Complying with FDA’s Most Recent Guidance” on December 8     
AGG Food & Drug team leader Alan G. Minsk is scheduled to present “Drug, Biologics, and Combination Products Labeling: Complying with FDA’s Most Recent Guidance” on December 8, 2020 at 11:00 am EST. Sponsored by FDANews, Alan will discuss the new FDA guidance on Instructions for Use (IFU), including a brief overview of the guidance, examples of sample labeling that covers IFU elements, type of language IFUs should be written in, practical considerations on patient labeling, and more. To register or to learn more about the program, please click here.
Robert Durkin to Moderate “Navigating Drug Preclusion Gaps for Food and Dietary Supplements Containing CBD” at FDLI’s Virtual Conference on December 8 
AGG attorney Robert Durkin is scheduled to moderate a session titled “Navigating Drug Preclusion Gaps for Food and Dietary Supplements Containing CBD” at the FDLI’s Legal and Practical Issues in the Evolving World of Cannabis Regulation virtual conference on December 8, 2020. Alongside with various industry leaders, Bob will discuss issues related to CBD, cannabis, and various regular product areas and state vs. federal regulation. To register or to learn more about the event, please click here
Industry Activities and Recognition

Carolina Wirth Interviewed by Bloomberg Health

AGG attorney Carolina M. Wirth was quoted by Bloomberg Law on November 12, 2020. Carolina commented on how the Food and Drug Administration flagged a plethora of “fraudulent and unproven medical products related to COVID-19” over the course of the pandemic. 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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