By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs
In the face of the COVID-19 pandemic, the U.S. Food and Drug Administration has worked hard to help facilitate the timely development of medical products. We have used our emergency authorities to make these products available to the public as soon as possible, provided the criteria for issuance are met. We have also kept our partners in public health — industry, health care providers, consumers, congressional leaders, and other stakeholders — updated of our actions and the decisions we have made throughout the pandemic.
The FDA’s three human medical product centers— the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Center for Biologics Evaluation and Research (CBER) — will co-host the Small Business Industry and Assistance (SBIA) Regulatory Education for Industry (REdI) Annual Conference to provide an overview of our regulatory operations during COVID-19. The annual event, which will run July 19-23, 2021, marks SBIA’s 10th anniversary and will be the first time that CDER, CDRH, and CBER are all participating.
Keynote: FDA’s Actions to Ensure Access to Medical Products During COVID-19
The FDA has been taking important actions to drive the development of medical products at a time when adjusting operations has been necessary. Some of these actions will be covered in my keynote address.
To speed product development during the pandemic, the agency has promoted the use of master protocols, in which one clinical trial design can evaluate more than one investigational product. In May 2021, the FDA issued a guidance, COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment and Prevention.
CURE ID, an internet-based repository originally developed to let clinicians report novel uses of existing drugs for difficult-to-treat infectious diseases, has been updated in response to COVID-19. Most recently, the FDA received a $9.2 million federal grant to enable automated data collection from electronic health records for CURE ID. The FDA and its partners are also developing a portal within CURE ID to let patients report their treatment experiences with the long-term effects of COVID-19. The automated data collection and the patient portal will focus on COVID-19, but these systems may eventually be used in other disease settings.
We also have created and implemented innovative approaches to inspections during the pandemic. Travel restrictions required us to temporarily postpone inspections while continuing with those considered “mission-critical.” We recently issued the Resiliency Roadmap for FDA Inspectional Oversight report, which describes the pandemic’s effect on our inspections activities and the alternative tools we used when in-person inspections were not possible. The report outlines the steps we are taking to resume standard operational levels of inspections.
Outside of COVID-19 exclusively, we are working to establish new regulatory approaches that can help improve predictivity and may replace, reduce, and/or refine, animal testing. Our January 2021 report, Advancing New Alternative Methodologies at FDA, outlines our activities in this realm.
In addition, the agency has promoted quality management maturity (QMM) — the concept of moving manufacturers beyond a focus on compliance with Current Good Manufacturing Practices and toward institutionalizing continual process and system improvements — to help mitigate drug shortages. The FDA’s 2019 Drug Shortages: Root Causes and Potential Solutions Report encouraged drug manufacturers to invest in QMM for their facilities. Since that time, the FDA has initiated two QMM pilot programs: one for finished dosage forms of drugs and one for active pharmaceutical ingredients.
Plenary Session: The Emergency Use Authorization Pathway to Allow Access to Medical Products
My keynote address will be followed by a plenary session that focuses on emergency use authorizations (EUAs). The EUA authority enables the FDA, pursuant to a declaration by the U.S. Department of Health and Human Services Secretary, to authorize an unapproved product or an unapproved use of an approved product for emergency use. In issuing an EUA, the FDA must determine, among other things, that the product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent; that the known and potential benefits, when used to treat, diagnose or prevent such disease or condition, outweigh the known and potential risks for the product; and that there are no adequate, approved, and available alternatives. The EUA authority has helped ensure that COVID-19 diagnostics, treatments, and vaccines have reached the market quickly.
In the plenary session, CDER, CDRH, and CBER directors will share their respective experiences with EUAs for drugs, devices, and biologics for COVID-19. All three centers have played and continue to play pivotal roles in this regard. For instance, CDER has been involved in authorizing COVID-19 treatment EUAs and supportive therapies, such as sedation for patients on ventilators, which have helped many people recover from the virus.
CDRH has worked to help authorize COVID-19 diagnostic tests, which have been critical in our response, as a sizable percentage of patients are asymptomatic. Other COVID-19 device EUAs include personal protective equipment, such as respirators and surgical masks, and devices to help with treatment, including ventilators and infusion pumps.
CBER has been involved in authorizing emergency use for the three COVID-19 vaccines, which have assisted in putting our nation on a downward slope in the number of COVID-19 cases. CBER has also worked to help facilitate the emergency use authorization of a biological product for the of treatment of COVID-19
EUAs can be expeditiously revised or revoked as more data become available or circumstances change. The FDA has leveraged this authority many times over the course of the pandemic.
REdI Sessions that Encourage Medical Product Development
Conference sessions will cover different aspects of fostering medical product development during COVID-19, including CDER presentations on:
- Efforts to facilitate marketing of generic drugs for potential treatments and supportive therapies.
- Strategies to address potential medication errors for products authorized for emergency use.
- Conducting clinical trials to help sponsors promote the safety of participants, maintain compliance with good clinical practice, and minimize risks to trial integrity.
There will also be sessions focused on the technical and scientific components of medical product operations unrelated to COVID-19. CDRH sessions, for example, will feature such topics as:
- Accelerating medical device innovation with regulatory tools.
- Best practices involving the 510(k) and Q submissions programs.
- Quality system principles for management and corrective/preventive actions.
CBER sessions will explore issues such as:
- Development of cellular therapies.
- Development of gene therapies.
- Regulations and policy considerations for human cells, tissues, or cellular or tissue-based products and “Tissue Rule” applicability to product development.
We encourage you all to attend to hear from and interact with the FDA leadership and subject matter experts at the conference. It is a great opportunity to learn about the critical work the FDA is doing to enhance product development and help ensure patients have access to therapies.