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FDA Gives Updates, Guidance for Cancer Community Regarding COVID-19

By Brielle Benyon
PUBLISHED WEDNESDAY, DECEMBER 31, 1969
Patients with cancer—and the providers treating them—have certain risks and needs when it comes to the coronavirus disease (COVID-19) pandemic in the United States, according to a recent statement from the Food and Drug Administration (FDA), which said that “patients with cancer and their unique needs continue to be a top priority.”

“We also recognize that oncology care providers themselves are faced with immense daily personal and professional challenges,” the statement said. “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.”

The FDA then went on to provide updates on how it is addressing the virus when it comes to the field of oncology.

Expedited Product Development


While many may think that the pandemic is preventing the investigation and approval of drugs and devices, the FDA assured the public that is not the case.

“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,” the statement said.

Clinical Trial Modification


However, there are some changes that must occur when it comes to conducting clinical trials, according to the FDA. Last week, the agency published guidelines on clinical trials during the COVID-19 pandemic for industry, investigators, and institutional review boards.

The guidelines put the safety and wellbeing of trial participants and investigators as top priority. The FDA recommended alternative measures for safety assessments (virtual visits, phone calls, etc.), changes in visit schedules, extra monitoring of patients who may no longer be able to participate in the trial, and more.

“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 statement said. “The guidance also acknowledges that FDA is aware of these challenges and will work with companies and investigators to maintain patient safety.”

Expanded Access for Investigational Products


The FDA emphasized that Project Facilitate, which assists providers with expanded access requests for investigational oncology products, is still available from 8:30 a.m. until 4:30 p.m. Eastern Standard Time at (240) 402-0004 or ONCProjectFacilitate@fda.hhs.gov. After-hour and weekend emergencies should call the Emergency Call Center at 1-800-300-4374.

Providers should contact the Division of Antivirals or Center for Biologics Evaluation and Research directly to request access, the FDA said. For patients and caregivers, they can be directed to the Division of Drug Information at (301) 796-3400 or email druginfo@fda.hhs.gov.

Preventing Drug Shortages


The Oncology Center of Excellence (OCE) continues to be in contact with the Center for Drug Evaluation and Research (CDER) to monitor the supply chain and any potential shortages.

“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 drugshortages@fda.hhs.gov,” the statement said.

Continued Information and Communication


The FDA vowed to continue to improve outreach and communications to the cancer community during this trying time. They encouraged citizens to follow @FDAOncology on Twitter and to check their website for frequent updates.

“We realize this is a stressful time for all Americans, but especially those with cancer, a life-threatening illness requiring the need for ongoing access to health care services. Here at the OCE, we are committed to patients with cancer and health care providers, and we are here for you at this most difficult time,” the statement said.

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