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

• It Is Not All About the Coronavirus Part 2: The CARES Act Brings Reforms to the Medical Device Industry
• Q&A: The CARES ACT and OTC Drug Reform in 2020
• With One Warning Letter, FDA Demonstrates Many of the Ways It Can Establish the Intended Use of a Product Labeled as a Dietary Supplement
• HHS Issues New Guidance on PREP Act Immunity When Prescribing, Administering, or Dispensing Drugs and Devices for COVID-19
• Status of USP Chapter 800 Becomes More (and Less) Clear Following USP Appeals Panel Decision
• Upcoming Events
• Industry Activities and Recognition

It Is Not All About the Coronavirus Part 2: The CARES Act Brings Reforms to the Medical Device Industry
By: Alan G. Minsk and Genevieve M. Razick

President Donald Trump signed the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) into law on March 27, 2020, to help mitigate the economic effects of the Coronavirus Disease 2019 (COVID-19) pandemic. In addition to providing substantial resources to combat the sharp economic decline due to the COVID-19 pandemic, the CARES Act also includes a number of provisions to further healthcare preparedness and response, including provisions aimed at the medical device industry. More >

To read Part 1 of this series, “It Is Not All About the Coronavirus: The CARES Act Brings Long-Awaited Over-the-Counter (OTC) Monograph Reform,” please click here. 

Q&A: The CARES ACT and OTC Drug Reform in 2020
By: Carolina M. Wirth and Genevieve M. Razick

In March 2020, the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) ushered in a wave of reforms to modernize the regulation of over-the-counter (OTC) drugs in the United States. A summary of some of the key provisions can be found in our bulletin entitled, “It Is Not All About the Coronavirus: The CARES Act Brings Long-Awaited Over-the-Counter (OTC) Monograph Reform.” Since we published that summary, we have received many questions concerning the upcoming changes to the OTC Drug Review process. We prepared the list below of some commonly asked questions and answers. More >

With One Warning Letter, FDA Demonstrates Many of the Ways It Can Establish the Intended Use of a Product Labeled as a Dietary Supplement
By: Robert Durkin

On March 31, 2020, the Food and Drug Administration issued a Warning Letter to a dietary supplement firm for making claims about its products that establish the products are unapproved new drugs, in violation of Federal Food, Drug, and Cosmetic Act (FD&C Act), because they are intended to cure, mitigate, treat, or prevent disease. In the Warning Letter, FDA outlined numerous claims that it observed on the company’s websites, Amazon storefront, and social media accounts for the products, which served as evidence of the products’ intended uses. More >

HHS Issues New Guidance on PREP Act Immunity When Prescribing, Administering, or Dispensing Drugs and Devices for COVID-19
By: Rebekah N. Plowman and Charmaine A. Mech

On April 14, 2020, the Department of Health and Human Services (HHS) issued an Advisory Opinion, which provided additional clarification on immunity provided under the Public Readiness and Emergency Preparedness Act (PREP Act) Declaration related to Coronavirus Disease 2019 (COVID-19). This article provides an overview of the PREP Act immunity for health professionals and provider entities prescribing, administering, or dispensing drugs, biologics, vaccines, or devices to treat, diagnose, cure, prevent, or mitigate COVID-19. More >

Status of USP Chapter 800 Becomes More (and Less) Clear Following USP Appeals Panel Decision
By: Jennifer L. Hilliard 

On March 12, 2020, an Appeals Panel of the United States Pharmacopeial Convention (“USP”) granted appeals to revisions of two compounding standards, which has a direct effect on the applicability within the USP compendium of USP Chapter <800>. More >

Carolina Wirth to Speak at ABA’s Panel Discussion on May 13th      

Join AGG attorney Carolina M. Wirth for a panel discussion, alongside industry and other legal experts, on May 13th at 12PM EDT, titled “How Will Law Treat Science and Medicine Once the Pandemic Subsides?” Hosted by the American Bar Association’s Section of International Law, panelists will provide an overview of the current and future legal and operational challenges brought on by the COVID-19 pandemic. More >

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