BloombergBusiness has another story of a jaw-dropping price hike for a very old medicine. In this case,
Colchicine, a gout remedy so old that the ancient Greeks knew about its effects, used to cost about 25 cents per pill in the U.S. Then in 2010 its price suddenly jumped 2,000 percent.
How did this happen? Colchicine is one of a small number of drugs that were marketed before 1938. That year, the Food, Drugs, & Cosmetics Act was passed to require new drugs to be approved for “safety” as well as be “pure” (that is, not adulterated or misbranded as required since 1906).
When the Act was amended to require “efficacy” in 1962, drugs approved since 1938 had to be approved again. However, pre-1938 drugs have never had to be approved. In today’s parlance, they were “grandfathered.”
Or, at least they were grandfathered until 2006, when the FDA decided to cause the makers of those drugs to apply for approval under the 1962 standards of both safety and efficacy. This is called the Marketed, Unapproved Drugs Initiative and Compliance Policy Guide.
Winning approval requires very expensive clinical trials. Pre-1938 drugs are no longer patented. However, forcing them to go through the FDA regulatory gauntlet effectively gives their manufacturers’ exclusivity similar to patents. The FDA asserts the unapproved drugs were unsafe, citing a few examples. Nevertheless, it looks like the cure has serious side effects, suggesting the FDA has overstepped reasonable boundaries by requiring drugs used for almost a century to submit to regulation.