FDA Announces Plans to Resume Domestic On-site Inspections

On July 10, 2020, Commissioner Hahn of the U.S. Food and Drug Administration (FDA) issued a statement announcing that the agency is planning to resume on-site inspections of domestic facilities during the week of July 20.  The Agency has developed a “COVID-19 Advisory Level” risk-based rating system to help assess where inspections may safely resume.  Under the rating system, facilities in areas where cases of COVID-19 are under control can expect to be inspected sooner than facilities in areas where COVID-19 cases are on the rise. Continue Reading

FDA Issues Guidance on Manufacturing Drugs, APIs during COVID-19

FDA issued new guidance on June 19, 2020, advising manufacturers of drugs, biologics, and active pharmaceutical ingredients (APIs) on manufacturing controls to prevent contamination of drugs with SARS-CoV-2, including performing risk assessments to determine whether the virus poses new risks to drug products, or to the manufacturing facilities or processes that produce them.  FDA is not aware of any drugs that have been contaminated with SARS-CoV-2, but the guidance provides the agency’s expectations for limiting potential contamination.  While the FDA has not yet resumed routine facility inspections, and therefore likely will not actively monitor implementation of the risk assessments (or other suggestions in the guidance), manufacturers should consider the recommendations in the guidance to protect the public health and health of their employees.

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Navigating FDA Policies for PPE, and Liability Protections

The US Food and Drug Administration (FDA) has been developing and shifting its guidelines for Personal Protective Equipment, or PPE, during COVID-19.  The Agency has articulated its guidelines for PPE in one of two ways: (1) through guidance documents and (2) through issuance of “umbrella” Emergency Use Authorizations (EUAs) that cover certain product types.  EUAs have the benefit of potentially providing manufacturers, distributors, and users of PPE with broad liability protections under the Public Readiness and Emergency Preparedness (PREP) Act (so long as the requirements and conditions of the EUA and the PREP Act declaration are met). Continue Reading

Not So Fast – FDA Retracts Authorization for Some Respirators Made in China

Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational Safety and Health (“NIOSH”) through the Families First Coronavirus Response Act, and the later expanded scope of that protection provided by the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act and amended PREP Act declaration by Department of Health and Human Services. Until recently, the list of devices eligible for liability immunity seemed to be continuously growing as the COVID-19 public health response required more and more PPE. But last week, the Food and Drug Administration (“FDA”) took a significant step back, retracting its Emergency Use Authorization (“EUA”) for respirators from 75 manufacturers in China, which previously had been approved for use in the response to COVID-19. This retraction has the additional effect of disqualifying government contractors, and other companies that distribute newly unauthorized respirators, from PREP Act immunity in connection with these devices.

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FDA Updates Policy to Curb Unreliable COVID-19 Antibody Tests

On May 4, 2020, the US Food and Drug Administration (FDA) updated its enforcement policy on antibody tests for COVID-19.  The revised policy requires developers of commercial antibody tests to submit a request for emergency use authorization (EUA) to FDA.  Under the previous policy, commercial test developers could distribute their tests without FDA authorization.  The change in policy reflects growing concerns over the reliability of antibody tests currently on the market.  The policy shift also suggests that manufacturers of medical supplies subject to relaxed enforcement policies during COVID-19 should monitor policy developments to confirm the regulatory status of their products. Continue Reading

April 16 Update: Key FDA Actions for COVID-19 Devices and Therapies

As reported earlier here, FDA is taking steps to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, support the development of therapeutics, and facilitate remote patient access to healthcare providers. Key FDA regulatory developments since our last update include new Emergency Use Authorizations (EUAs) for face shields, N95 respirator decontamination systems, and equipment to treat respiratory failure.  Continue Reading

Upping Hospitals’ Liability Defenses For COVID Measures

This article originally appeared in Law360 on April 13.

The Public Readiness and Emergency Preparedness Act, along with the declaration by the U.S. Department of Health and Human Services on countermeasures against COVID-19, provide hospital systems with broad liability protections for measures taken in response to the pandemic. Continue Reading

Update: Key FDA Actions for COVID-19 Devices and Therapies

FDA is taking action every day to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, to support the development of therapeutics, and to facilitate remote patient access to healthcare providers. Recent key FDA developments include: Continue Reading

Personal Protective Equipment & Ventilators: How FDA Is Increasing Supply for the US Healthcare System

In light of the widely reported shortage of personal protective equipment (PPE), ventilators, other medical devices, the U.S. Food and Drug Administration (FDA) is working around the clock to authorize medical supplies for the US healthcare system, including relaxing its rules for importing and distributing PPE and ventilators and their accessories (e.g., vent splitters for multiple patient ventilation).  FDA’s policies on permitting uncleared medical devices shift daily toward greater relaxation of regulatory hurdles for suppliers and manufacturers.  The most recent policies on PPE importation and use in healthcare settings create more options for healthcare providers and patients in need of ventilatory support and help alleviate bottlenecks of necessary medical supplies in the supply chain. Continue Reading

FDA Grants COVID-19 Diagnostic Emergency Use Authorizations, And Other Recent FDA Actions to Address COVID-19

The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUA) for commercially distributed COVID-19 diagnostic tests at the end of last week.  The first authorization was issued to Roche Molecular Systems, Inc., for its cobas SARS-CoV-2 Test, and the second issued the following day to Thermo Fisher Scientific, Inc., for its TaqPath COVID-19 Combo Kit.  Both tests are for the qualitative detection of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19). FDA granted the authorizations within 24 hours of receiving the requests.

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