AGG Food and Drug Newsletter - November 2020

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.

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. 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 >

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 >

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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