It takes 10–15 years and hundreds of millions of dollars for a pharmaceutical company to navigate the Food and Drug Administration (FDA) regulatory process and bring a new drug to market. Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already approved, a phenomenon called "drug lag." It is impossible to imagine how many drug remedies remain undiscovered and how many people needlessly suffer because pharmaceutical companies must divert excessive research and development dollars to the drug approval process, a phenomenon called "drug loss."
Congress passed the Food, Drug, and Cosmetic Act (FDCA) in 1938 to ensure drug safety. The new law exempted drugs people had been using for several years, such as aspirin or regular insulin, from the FDA approval process. But it also required drugmakers to henceforth provide convincing evidence to the agency that any new product is safe for patients to consume as directed. When Congress passed the Kefauver-Harris Amendment to the FDCA in 1962, it required drugmakers to convince the agency a new drug was effective as well as safe, adding millions of dollars and several years to the approval process, inflating the length of time it takes the agency to allow people to consume pharmaceuticals.
