- For Immediate Release:
The following quote is attributed to Acting FDA Commissioner Janet Woodcock, M.D.
During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities that manufacture FDA-regulated products. These tools include record requests in advance of or in lieu of a drug facility inspection, relying on information from trusted regulatory partners, and remote interactive evaluations (such as remote livestreaming video of operations, teleconferences and screen sharing). We have used some or all of these approaches to evaluate facilities for human and animal medical products during the public health emergency when inspections of drug facilities were not possible due to travel or quarantine restrictions.
Inspections are an important tool to keep Americans safe, and are part of a set of tools used for regulatory oversight. As part of the wide variety of tools we have deployed during the COVID-19 pandemic, remote interactive evaluations have informed the FDA’s regulatory decision-making, contributed to ensuring drug quality and helped determine the scope, depth and timing of future inspections. By necessity, we have adapted by conducting more remote interactive evaluations throughout the public health emergency and are continuing to expand their use as appropriate. The purpose of this new guidance is to provide further clarity for regulated facilities on how the FDA will request and conduct these remote interactive evaluations during the COVID-19 public health emergency.
We recognize that remote interactive evaluations do not replace inspections, and that there are situations where only an inspection is appropriate based on risk and history of compliance with FDA regulations. Within the exceptional context of a global pandemic, we see remote interactive evaluations as part of a necessary strategy to evaluate medical product facilities by using all available approaches to ensure the medical products we regulate are safe, effective and of high quality.
- Today, the U.S. Food and Drug Administration announced the availability of a guidance document entitled, “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency.” This guidance describes various interactive and virtual tools. The agency refers to its use of any combination of these interactive tools as a remote interactive evaluation.
- This guidance describes how remote interactive evaluations will be requested by the FDA and conducted for the duration of the COVID-19 public health emergency at any facility where pharmaceutical products, including biological products, are manufactured, processed, packed or held; facilities covered under the FDA’s bioresearch monitoring program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act.
- The agency will use existing risk management methods and related tools to determine when to request a facility’s participation in a remote interactive evaluation. The FDA conducts inspections for many purposes and programs, including pre-approval and pre-license, post-approval, surveillance, for-cause and bioresearch monitoring programs. The agency will consider each of these inspectional program areas as possible candidates for remote interactive evaluations, recognizing that there will be instances where only an inspection will be appropriate.
- The FDA intends to use information from remote interactive evaluations to meet user-fee commitments and to update facilities information, when deemed appropriate based on risk and history of compliance with FDA regulations. Facilities can choose to decline the FDA’s request to perform a remote facility evaluation; however, this may delay the agency’s ability to evaluate the facility or product and make a regulatory decision. The FDA will not accept requests from applicants or facilities to perform a remote interactive evaluation, as decisions to offer a remote interactive evaluation will rest with FDA, based on risk and compliance history.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Jeremy Kahn
- (301) 796-8671