Federal Regulation of Medication Production

Excerpt

Even though the United States is allegedly a capitalistic economy with an overall laissez-faire approach to consumer products, its federal government has established various regulatory agencies to secure consumer health. In the early 20th century, different unethical business practices posed threats to consumer health. In a cascade of events originating from the sulfanilamide disaster of 1937, the US Congress passed the Food, Drug, and Cosmetic Act of 1938 (FDCA). The FDCA led to the Food and Drug Administration (FDA) establishment, which oversaw the production of new drugs via a form called the New Drug Application (NDA).

With changing times and the progress of science, the FDA's significance prevailed. The 1962 Kefauver-Harris Amendments extended the powers of the FDA, mandating drug manufacturers to prove both drug safety and effectiveness with "substantial evidence" before the FDA would grant production approval. We retrospectively delve into regulatory details about the development and enforcement of federal rules about medication production to discuss further editions that may help improve those sectors, which may also help physicians and allied healthcare professionals to become aware of federal regulations that may allow them to practice informatively.