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Ancient gout drug lost its rivals
Grandfathered in
Colchicine is an ancient gout remedy. It was developed as a medicine long before the FDA existed and before drug regulation existed, so neither it nor its generic copies were ever formally approved. They stayed on the market because they were grandfathered in, sort of approved by their age.
The FDA's offer
At some point the FDA built a pathway to get companies to test whether these old drugs were actually effective, including for other uses. The offer was exclusivity to sell them for anyone who tested a grandfathered drug and succeeded.
The trial and the price
A company called URL Pharma tested colchicine and the trial succeeded. The FDA granted exclusivity and cleared out all of the unapproved competitors, which left URL's version the only one on the market. The company raised the price massively, and everyone got really mad.
Why do some old drugs have no approval?
The 1938 US Federal Food, Drug, and Cosmetic Act required proof of safety for new drugs, and drugs already on the market were largely exempt. The 1962 Kefauver-Harris Amendments added a requirement to prove effectiveness, and the FDA reviewed older drugs through a program called DESI, but many stayed in a gray zone. In 2006 the FDA announced a campaign to bring unapproved drugs through the approval process. The FDA approved colchicine tablets from URL Pharma in 2009.
How does colchicine calm a gout attack?
Colchicine comes from the autumn crocus, a plant that physicians have used for joint pain since antiquity. It binds tubulin, the protein that builds the internal scaffolding of cells. Without that scaffolding, white blood cells called neutrophils cannot move into an inflamed joint as easily. In gout, uric acid crystals in the joint are what draw those cells in.
Why does the FDA reward testing old drugs?
The Hatch-Waxman Act of 1984 allows three years of exclusivity for a drug whose approval depended on new clinical investigations run by the sponsor. The aim is to pay for evidence that a copycat maker would never fund, since a copied drug earns little. For old unapproved drugs, an approval changes the legal footing of every other maker. Once one maker holds an approval, the FDA can enforce against unapproved versions of the same drug.
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