The U.S. Food and Drug Administration (FDA) has taken several actions on vaccines and diagnostics in our ongoing response effort to the COVID-19 pandemic.
The FDA issued a safety alert for fecal microbiota transplantation (FMT) procedures and potential for transmission of the COVID-19 virus through FMT, a procedure that delivers human donor stool into the colon of a patient to treat c. difficile infection in patients that have not responded to standard therapies.
Several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals. This information suggests that SARS-CoV-2 may be transmitted by FMT, although the risk of such transmission is unknown.4 At this time, testing nasopharyngeal specimens from stool donors for SARS-CoV-2 may not be widely available. Furthermore, there is limited information on the availability and sensitivity of direct testing of stool for SARS-CoV-2.
At this time, FDA is advising that clinical use of FMT has the potential to transmit SARS-CoV-2, whether used as part of a study under an Investigational New Drug Application (IND) on file with the FDA or under FDA’s enforcement discretion policy. To address the risk, stool used for FMT should have been donated before Dec. 1, 2019. Due to the potential for serious adverse events to occur, FDA has determined that the following protections are needed for any use of FMT that is found to be necessary for clinical care if it involves stool donated after December 1, 2019:
- Donor screening with questions directed at identifying donors who may be currently or recently infected with SARS-CoV-2;
- Testing donors and/or donor stool for SARS-CoV-2, as feasible;
- Development of criteria for exclusion of donors and donor stool based on screening and testing; and
- Informed consent that includes information about the potential for transmission of SARS-CoV-2 via FMT, including FMT prepared from stool from donors who are asymptomatic for COVID-19.
The FDA also updated its FAQ on Diagnostic Testing for SARS-CoV-2 regarding specimen collection for COVID-19 testing. Based on available data, FDA believes that, for symptomatic patients, nasal swabs could be used that access just the front of the nose rather than the depth of the nasal cavity. This would provide COVID-19 testing that is more comfortable for patients, allows self-collection of specimens at collection sites, and that can be performed with a simpler and more readily available swab.
The FDA Oncology Center of Excellence recognizes that patients with cancer constitute a vulnerable population at risk of contracting the coronavirus disease (COVID-19). While everyone’s daily lives have been disrupted during the COVID-19 pandemic, the impact may be hardest on those with acute or chronic medical conditions and those with weakened immune systems, such as that caused by cancer and some forms of cancer treatment.
The FDA also recognizes that oncology care providers themselves are faced with immense daily personal and professional challenges. Many of our colleagues are on the front lines of caring for patients with cancer, concerned about protecting the safety of their patients, as well as themselves and their families, while assuring their patients’ access to needed treatment and clinical trials.
FDA is working to address critical issues for patients with cancer and their healthcare providers. Current priorities:
· FDA continues to expedite oncology product development. Our staff is teleworking full time and continuing to meet virtually with drug developers, academic investigators, and patient advocates to push forward the coordinated review of drugs, biologics, and devices for cancer.
· FDA recognizes that modifications may be required in clinical trials. OCE contributed to the recently issued FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic. The guidance assists sponsors in assuring the safety of patients involved in clinical trials, keeping patients informed of changes that could impact them, maintaining compliance with good clinical practice, and minimizing risks to trial integrity. The guidance also acknowledges that FDA is aware of these challenges and will work with companies and investigators to maintain patient safety.
· FDA continues to process Expanded Access requests for investigational products. Project Facilitate remains open at (240) 402-0004 or [email protected], to assist oncology healthcare providers and regulatory professionals in requesting access to investigational therapies for patients for the treatment of cancer when no satisfactory therapies are available and there is no opportunity for the patient to enroll in a clinical trial. Health care providers caring for patients with cancer and COVID-19 who are seeking an investigational treatment specifically to treat COVID-19 should contact the Division of Antivirals or CBER directly to request access. Patients and caregivers who need information about accessing investigational therapies may contact the Division of Drug Information at (301) 796-3400 or email [email protected].
· The FDA is also working to anticipate and prevent drug shortages. OCE is in regular contact with the FDA’s drug shortages staff within the Center for Drug Evaluation and Research. FDA is proactively monitoring the supply chain, and OCE will work closely with CDER to prevent or mitigate shortages of oncology drugs that are critical to the treatment of patients with cancer. Shortage notifications and updates may be reported to FDA at [email protected].
Diagnostics update: In certain emergencies, the FDA can often quickly issue an emergency use authorization for diagnostic tests based on FDA’s rolling review of data and where the request meets certain criteria. In the COVID-19 pandemic, the FDA has worked with more than 160 test developers who have said they will be submitting applications to make tests that detect the virus. To date, 15 emergency use authorizations have been issued for nation-wide use. Under their laboratory developed test policy during COVID-19, the FDA has been notified by more than 65 laboratories.
