The Center for Drug Evaluation and Research (CDER), which assures that safe and effective drugs are available to the American people, has gone through a functional and organizational metamorphosis since it began as a one-man operation to assess significant drug problems in the marketplace on the eve of the 1906 Pure Food and Drugs Act. In part, this change reflects the evolution of drug law and the chemotherapeutic revolution over the 20th century--and the concomitant changes in responsibilities of the Food and Drug Administration. But the change also reflects external and internal decisions on how best to provide safe and effective drugs to patients. Every branch of government, as well as other interests affected by FDA's policies, have had a role in the way this agency regulates drugs.
The following story summarizes some of the dynamics involved in the history of the drug regulatory function at FDA, especially with respect to the many organizational upheavals this function experienced over the past 90 years.