Abolish the FDA
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.
Strangely, when the FDA finally permits a pharmaceutical company to market a drug for a specific condition placed on the label, the agency allows clinicians to recommend the drug to their patients for any condition they think it might help. Anywhere from one-fifth to one-third of all medicines that clinicians prescribe and people consume are for these “off-label” uses.
In other words, the FDA forces drugmakers to prove that a drug works for condition A but defers to clinical researchers in the private sector and academia to determine whether it works for conditions B through Z. Why doesn’t the FDA defer to clinicians for condition A?
Sometimes off-label drug use yields benefits. For example, clinical researchers
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