On March 23, the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) issued the following statement:
The FDA OCE 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 those caused by cancer and some forms of cancer treatment.
We also recognize 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.
In this critical time, we want you to know that we are here for patients with cancer and their health-care providers and we will do everything we can to help you through this difficult period. Although our nation’s emphasis is on the need to combat this virus, patients with cancer and their unique needs continue to be a top priority.
To that end, we are working to address critical issues for patients with cancer and their health-care providers. Here are a few of our current priorities:
- We continue 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.
- We recognize 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 the FDA is aware of these challenges and will work with companies and investigators to maintain patient safety.
- We continue to process Expanded Access requests for investigational products. Project Facilitate remains open at (240) 402-0004 or ONCProjectFacilitate@fda.hhs.gov from 8:00 AM to 4:30 PM EST, Monday through Friday, to assist oncology health-care 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. For after-hours emergency requests, contact FDA’s Emergency Call Center at 1 (800) 300-4374. 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 The Center for Biologics Evaluation and Research 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 druginfo@fda.hhs.gov.
- We are working to anticipate and prevent drug shortages. The OCE is in regular contact with the FDA’s drug shortages staff within the Center for Drug Evaluation and Research (CDER) The FDA is proactively monitoring the supply chain, and the 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 the FDA at drugshortages@fda.hhs.gov.
- We will continue to inform the cancer community. Our work to improve education, resources, outreach, and communications regarding cancer product development continues unabated. We encourage you to follow @FDAOncology on Twitter and check our website for regular updates.
