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 Episode 3: I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues 
• Ain’t No Sunshine When the Government Comes: The DOJ and OIG Enforce the Sunshine Act
• Will the Next Therapeutic Emergency Use Authorization be for a Vaccine? FDA Announces Additional Steps to Increase Emergency Use Authorization Transparency
• The OIG Says There is No Such Thing as a Free Meal
• Warnings of Ransomware Activity Targeting the Healthcare Sector and Potential Sanctions for Making Ransomware Payments
• Voters Approve the California Privacy Rights Act, Expanding California’s Data Privacy Law
• 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
• Predicting White Collar Enforcement Priorities in the Biden Administration
• Upcoming Events
• Industry Activities and Recognition

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.

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. Minsk, Rebekah 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 >

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

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