On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Acknowledging that the COVID-19 emergency will not last forever, the FDA’s recent draft guidances propose a 180-day transition path back to “normal operations,” i.e., compliance with the Federal Food, Drug, and Cosmetic Act (FDCA) and regulatory requirements. The transition periods, which would begin (in most cases) 180 days after the end of the public health emergency (PHE), would allow manufacturers, healthcare facilities, and other stakeholders to avoid supply disruptions and product shortages. Following the transition period, manufacturers who want to continue selling covered devices would be expected to comply with all the usual regulatory requirements. Manufacturers who do not wish to continue distribution post-PHE could keep business as usual through the end of the 180-day transition period. Comments on the draft guidance are due on March 23, 2022.  The guidance for EUA devices can be found here, and for devices marketed under COVID-19 enforcement policies, here.
Continue Reading FDA Releases Guidances on Transition Plan for Devices Distributed Under Emergency Use Authorization (EUA) or Enforcement Policies During COVID-19

On Wednesday, May 7, 2021, the United States officially endorsed waiving intellectual property protections for COVID-19 vaccines. While the United States has taken the opposite position in recent months, the administration asserts that its departure is guided, at least in part, by the goal “to get as many safe and effective vaccines to as many people as fast as possible.”[1] That goal, however, is unlikely to be affected by such a waiver in the short term due to uncertainty in World Trade Organization (“WTO”) politics, ongoing shortages on raw materials and equipment, and lag-time in retrofitting potential manufacturers.
Continue Reading Waiver Of Intellectual Property Protections For COVID-19 Vaccine Unlikely To Have Meaningful Impact In Short Term

On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a consistent state of inspection operations.  For the near term, FDA reports that it will continue to prioritize critical inspections of both domestic and foreign facilities, including preapproval inspections for priority products and inspections in reaction to recalls or other safety issues.  For the long term, the agency likely will employ the remote monitoring strategies it has implemented during the pandemic and expand its remote data collection capabilities to preserve resources and curb in-person inspections.
Continue Reading FDA Proposes Risk-Based and Remote Inspection Strategies in New Report

On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19.  According to the guidance, FDA will request and conduct voluntary remote evaluations at (1) facilities where drugs and biologics are manufactured, processed, packed, or held; (2) facilities covered under the bioresearch monitoring (BIMO) program; and (3) outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA).  The evaluations do not replace in-person inspections, and FDA Form 483s will not be issued as a result of the inspection, but the results could be used to support regulatory actions, such as approving a pending product application. 
Continue Reading Breaking Down FDA’s New Remote Monitoring Strategy

This week, FDA Commissioner Stephen M. Hahn, M.D., along with Dr. Anthony S. Fauci, M.D., of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, and officials from the Centers for Disease Control and Prevention and U.S. Department of Health and Human Services testified on Capitol Hill on the federal response to COVID-19, including the latest on vaccine development and facility inspections.  FDA also issued an updated guidance on conducting clinical trials during COVID-19, showing its willingness to continue to adapt its policies to facilitate remote patient access during COVID-19.
Continue Reading FDA Update: The Latest on Vaccine Development, Inspections, and Conducting Clinical Trials During Covid-19

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 Announces Plans to Resume Domestic On-site Inspections

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

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 Navigating FDA Policies for PPE, and Liability Protections

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

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 FDA Updates Policy to Curb Unreliable COVID-19 Antibody Tests

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