Debra Boyd-Seale, Consumer Safety Officer, Office Bioresearch Monitoring Operations (OBIMO) West Group 2
I conduct inspections of clinical trials. In response to the COVID-19 pandemic, the Office Bioresearch Monitoring Operations (OBIMO) worked tirelessly to review data which the FDA used to approve lifesaving treatments. I was fortunate to have a role in this important work. I am Debra Boyd-Seale, a consumer safety officer with OBIMO West in the FDA's Office of Regulatory Affairs (ORA).
When there is an application submitted for a new drug, new device, and/or a new use for previously marketed drugs and devices, the FDA must first determine the product is safe and effective for diagnosing, treating, and/or preventing illness, injury, or disease. With respect to the COVID-19 pandemic relief efforts, my colleagues and I conducted inspections of Remdesivir clinical trials. Our work included visiting hospitals, reviewing clinical data and research participants’ medical records, interviewing physicians caring for COVID-19 patients, and visiting pharmacies where the drug was stored. We reviewed data to ensure the safety of the research participants and to help the Center for Drug Evaluation and Research determine the safety and efficacy of the drug. As a result of our collective work, Remdesivir was approved to treat COVID-19.
Living through the COVID-19 pandemic has been a challenge for the world and for me personally. I have had friends survive COVID-19 and have lost family members to COVID-19. I’ve had conversations about vaccine safety. As an African American woman, healthcare professional, family member, and FDA employee, I try to reassure people COVID-19 vaccines are safe. I want people to understand we can lessen the COVID-19 death rates if we vaccinate. I’ve held zoom meetings to educate my family and I have had one-on-one conversations with my friends about the safety of the vaccines. I tell my family and friends I love them; I don’t want to lose anyone else from COVID and I know the vaccine is safe! I work for FDA.
In 20 years, I want to share with my family and friends that as an FDA ORA employee, I did my part to help the world mitigate the impact of COVID-19, especially among our most vulnerable populations.
My name is Debra Boyd-Seale and #IAmORA and I am helping you to be #VaccineReady!