Postapproval Marketing Practices Regarding Drug Safety and Pharmacovigilance
INTRODUCTION Historically, the regulation of drugs in the United States has been driven by a concern for the safety of the drug product. From the Pure Food and Drug Act of 1906, the FD&C Act of 1938, and to the present day, drug safety has been the overriding concern. During the past century, drug regulation at the Food and Drug Administration (FDA) has evolved to a large extent in terms of statutory reforms. Past changes have more often than not been a response to new challenges to the understanding of drug safety. Although the FDA is highly respected as one of the world’s premier regulatory bodies, recent events have called into question FDA’s regulatory decision-making and oversight processes, and caused the public to question its ability to provide an acceptable level of drug safety.