A NEW STORM is brewing over how to maintain effective and expeditious regulation of an ever-broadening spectrum of biological products, ranging from vaccines, allergens, blood, and diagnostic agents to a whole string of new biotechnologically derived agents. At stake is the capacity of the Food and Drug Administration (FDA) to protect the health of the public.
The paramount issue is safety. Unlike drugs that are used to treat existing illnesses, many biological products, such as vaccines, are used to prevent disease, and in some instances, such as childhood immunizations, their use is mandatory.
Marwick C. FDA Funding Problems Imperil Safety of Biological Products in the United States. JAMA. 1998;279(12):899-901. doi:10.1001/jama.279.12.899-JMN0325-2-1