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 found that the anti-nausea medicine thalidomide, which caused birth defects when pregnant women used it for morning sickness, was effective in treating leprosy and multiple myeloma when clinicians prescribed it off-label. Similarly, doctors recommended aspirin off-label to prevent cardiovascular problems. On the other hand, clinicians can discover that off-label use of a drug can be harmful or inappropriate. For example, some of the deaths from elixir sulfanilamide in 1937 occurred when doctors prescribed it for off-label purposes, such as Bright’s disease (an old name for kidney inflammation), mercury poisoning, and backache.
When it comes to off-label uses of drugs, endorsements of efficacy originate from entities distinct from the FDA. In addition to publications like Consumer Reports, these include peer-reviewed medical journals, the U.S. Pharmacopeia, and several other private compendia. Federal law requires the Medicare and Medicaid programs to rely on specific, privately compiled drug compendia to certify the efficacy of off-label uses. Similar to how the government grants physicians the freedom to prescribe prescription-only medications for off-label uses, it grants patients the freedom to use over-the-counter drugs for off-label purposes.
The FDA even relied on a private third-party reviewer, the National Research Council of the National Academy of Sciences, to test drugs’ efficacy from 1938 to 1962. The American Medical Association’s Council on Pharmacy and Chemistry conducted safety and efficacy evaluations long before Congress passed the FDCA until it shuttered operations in 1955, crowded out by the FDA. Even then, it initiated a registry for reporting drug reactions.
One intermediate step toward pharmaceutical freedom and progress would be for Congress to enact “international drug reciprocity.” This would allow American doctors and patients to access drugs and devices approved by regulatory agencies in similar, trusted countries. There is no logical reason why Americans should not have access to products approved in countries like Canada, France, the United Kingdom, Switzerland, Australia, New Zealand, and Israel, many of which have engaged in reciprocity for years.
Many people can’t imagine a world where the FDA doesn’t have a monopoly on drug approval. Yet there will always be a market for drug safety and efficacy information. Ending the agency’s monopoly will allow innovation and competition into that space, benefiting everyone—even former FDA bureaucrats.
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