Perspectives on Food, Drug, Medical Device & Cosmetic

For years, regulators, industry, and lawmakers alike have sought to modernize the regulatory framework under which most over-the-counter (OTC) drugs are marketed in the US. With the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) on March 27, 2020.

As the United States begins to see positive signs that mitigation efforts such as stay-at-home orders and social distancing are working, the question of when people can return to work and resume normal activities is one of the most critical issues facing the country – and indeed the world. 

FDA continues at a relatively fast clip to issue policies intended to help solve a dire problem: the ongoing need to expand the availability of certain medical products in the US that are critical to addressing the COVID-19 pandemic.

On April 14, 2020, the journal Science published on-line a “First Release Notification” paper entitled “Projecting the transmission dynamics of SARS CoV-2 through the postpandemic period” by scientists from the Departments of Epidemiology and of Immunology and Infectious Diseases at the Harvard Scho

Food, Drug, Medical Device & Cosmetic Group Leader Deborah Shelton is serving as Curriculum Advisor for the Food and Drug Law Institute’s Introduction to Drug Law and Regulation virtual event on April 15-16.

As recently as March 27, the WHO was stating on its website that there was insufficient evidence to suggest that the novel coronavirus was airborne except in a handful of medical cases, such as when intubating an infected patient.

FEMA has exercised its delegated authority under the Defense Production Act to issue a temporary final rule to prohibit the export of five types of medical PPE that the US government previously identified as scarce and threatened material in the COVID-19 pandemic.

This updates our prior Alert regarding the importation and distribution of respirators and other masks to be used to meet the significant US health care challenges posed by the COVID-19 pandemic.

On March 31, Health & Human Services Secretary Alex Azar announced the creation of a new FDA program, the Coronavirus Treatment Acceleration Program (“CTAP”), designed to speed up the development of life-saving treatments that have the potential to be both safe and effective.

In a letter dated March 28, FDA announced it was issuing an Emergency Use Authorization for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19.

As part of its ongoing effort to address the critical shortage of Personal Protective Equipment (PPE) needed to address the COVID-19 pandemic, FDA has issued an Enforcement Policy to help expand the availability of surgical apparel for healthcare professionals, including gowns and gloves.

As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for ventilators, accessories, and other respiratory devices.

Over the past weekend, the FDA issued yet another Final Guidance to relax the rules governing medical devices.

Teva Pharmaceuticals filed suit against the United States Food and Drug Administration (FDA) alleging that its glatiramer (Copaxone) falls under the revised definition of a “biological product” and should be transitioned to the system established by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

This updates our prior Alert regarding the importation and distribution of face masks and respirators to be used to meet the significant US health care challenges posed by the COVID-19 pandemic.

Arent Fox continues to monitor the FDA activities and scientific reports on COVID-19 and the novel coronavirus.

As we reported earlier this week, in an effort to increase the domestic supply of hand sanitizer, the US Food and Drug Administration (FDA) recently announced policies that temporarily relax certain requirements for the production of alcohol-based hand sanitizer.

FDA has issued a new Enforcement Policy that allows manufacturers of certain FDA-cleared non-invasive devices to expand their use for healthcare professionals to monitor patients remotely during the COVID-19 pandemic.

Arent Fox continues to monitor the latest scientific reports on COVID-19 and the novel coronavirus for issues that may be of general concern to our clients.  

FDA has issued a new Guidance to address certain challenges to clinical trials during the COVID-19 pandemic. This Guidance takes effect immediately and applies to clinical trials of drugs, biologics, and medical devices.

The coronavirus (COVID-19) outbreak has led to a dramatic increase in the demand for, and a shortage of, hand sanitizer in the US.

FDA has just issued what it calls “FAQs on Diagnostic Testing for SARS-CoV-2” that provides information on which tests and which testing laboratories have received Emergency Use Authorization for the testing for the COVID-19 virus.

FDA has just published a new Guidance that will allow for the suspension of reporting of certain adverse event reports while the COVID-19 pandemic continues.

News reports show that because of the spread of the novel coronavirus (COVID-19) pandemic, hospitals and medical facilities are overwhelmed and threaten to strain the healthcare system.

By now, almost everyone is aware of the dire situation that exists in the United States for testing patients with the Coronavirus.