Controversial FDA Official Claims Link Between COVID-19 Vaccines and Pediatric Deaths

## Overview The **U.S. Food and Drug Administration (FDA)** is a federal agency within the Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of a wide range of products, including human and veterinary drugs, biologics, medical devices, food, cosmetics, and products that emit radiation[1][2][3]. Its mission is to advance public health by helping to speed innovations that make medical products safer, more effective, and more affordable, while providing the public with accurate, science-based information about these products[1]. ## Functions and Regulatory Scope The FDA’s regulatory authority is expansive. It oversees the approval, manufacturing, marketing, and distribution of prescription and over-the-counter drugs, vaccines, blood products, medical devices (from simple tongue depressors to complex pacemakers), dietary supplements, most foods (except some meat, poultry, and egg products regulated by the USDA), cosmetics, and tobacco products[1][2][5]. The agency also regulates electronic products that emit radiation, such as X-ray machines and microwave ovens[2][5]. Importantly, the FDA does not regulate the practice of medicine, medical services, product pricing, or health insurance reimbursement[2]. The FDA achieves its goals through a combination of **premarket reviews**, **post-market surveillance**, **facility inspections**, **enforcement actions**, and **public education**[3][4]. It maintains several adverse event reporting systems—such as MedWatch and VAERS—to monitor product safety after they reach the market[4]. The agency also plays a key role in the nation’s counterterrorism efforts by ensuring food supply security and fostering the development of medical countermeasures[1]. ## History and Key Achievements Established in 1906 with the passage of the Pure Food and Drugs Act, the FDA’s origins trace back to efforts to combat adulterated and misbranded food and drugs. Its regulatory powers expanded significantly with the

The Center for Biologics Evaluation and Research (CBER) is a pivotal division of the U.S. Food and Drug Administration (FDA), established in 1902 following tragic incidents involving contaminated biological products. Originally part of the National Institutes of Health, CBER moved to the FDA in 1972 and has since become a global leader in regulating biologics—products derived from living sources such as humans, animals, and microorganisms. These include vaccines, blood and blood components, allergenics, cellular and gene therapies, tissues, and certain medical devices. CBER’s mission is to ensure the safety, purity, potency, and effectiveness of these advanced therapies, which often represent the cutting edge of biomedical innovation. The center evaluates scientific and clinical data submitted by manufacturers, making regulatory decisions based on a rigorous risk-benefit analysis. CBER also oversees the licensing and post-market surveillance of biologics, ensuring that products remain safe and effective throughout their lifecycle. A key aspect of CBER’s work is its role in facilitating the development and approval of novel technologies, including gene therapies and regenerative medicine products. The center is organized into specialized offices, such as those for vaccines, blood, and cellular therapies, and employs a cadre of scientific experts who bridge regulatory science and public health. CBER also collaborates with external advisory committees to seek expert input on complex scientific and technical issues. Today, CBER continues to shape the future of healthcare by advancing regulatory science, supporting innovation, and safeguarding public health. Its work is critical for companies in the biotech and pharmaceutical sectors, as it sets the standards for bringing life-saving biologics to market.