Insights on Life Sciences

FDA has yet again revised its Enforcement Policy for the US importation and distribution of face masks and respirators during the COVID-19 pandemic.

The FDA has just published a list of certain already-on-the-market serology/antibody tests from commercial manufacturers that should not be distributed unless and until an Emergency Use Authorization (EUA) is issued for the test.

On Friday, May 22, 2020, the USDA and FDA jointly released recommendations to address shortages of personal protective equipment (PPE), cloth face coverings, disinfectants, and sanitation supplies in the food and agriculture industries.

“Testing, Testing, Testing” is the new mantra. The politicians and the press are full of the few reports of testing successes and the many reports of testing failures throughout the country and around the world.

On May 8, 2020, the FDA announced that it had authorized the first COVID-19 diagnostic test that can be used to collect saliva in the home.

What one hand giveth, the other can taketh away. That adage comes to mind when reviewing FDA’s most recent action with respect to the importation and distribution of KN95 and other respirator masks manufactured in China. 

The presence in the blood of antibodies specific to the novel coronavirus may help identify those who were unknowingly exposed to the virus but remained asymptomatic, those who were symptomatic but have fully recovered, and, as a result, those who might now have immunity, at least temporarily. Howev

On May 4, 2020, the FDA issued new Guidance that drastically changes the requirements for serology/antibody tests for the COVID-19 epidemic.

This updates our prior Alerts regarding the importation and distribution of face masks during the COVID-19 pandemic. The daily news is replete with reports of various types of masks and other personal protective equipment (PPE) that pose supply challenges due to high demand.

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.