FDA Regulatory Overreach Allows Price Gouging

Recently news has been circulating that condemns Turing Pharmaceuticals for price gouging United States consumers of pyrimethamine1 an antimalarial which sells for under ten cents per dose in markets other than the United States where generic forms are available. Pyrimethamine is very popular in areas of the world where malaria is endemic due to its efficacy against most strains of the falciparum and vivax species of the Plasmodium malaria parasite, but in the United States it is typically used to treat toxoplasmosis in immunocompromised patients making it a niche treatment. Turing Pharmaceuticals managed to get a contract to exclusively market pyrimethamine in the United States thanks to FDA regulations. Because the FDA allows them exclusive marketing rights they can set prices arbitrarily, and if they can they must.

Because the FDA allows them to bar the sale of their US approved form of pyrimethamine to generic manufacturers who have safely and cheaply been supplying the rest of the world with this drug so they can demonstrate product equivalence they must. Other pharmaceutical companies routinely play exactly this game2 according to the rules explicitly laid out by the United States Food and Drug Administration with the blessing of Congress. Normally this game is played with still more niche drugs for treating particular cancers, but because this drug happens to treat a condition associated with AIDS3 this story was able to be packaged in a way that triggered outrage across a variety of interest groups.

The outrage here is a distraction from the actual issue of fiat, inflation, and malinvestment destroying the actual meaning of money. Turing Pharmaceuticals works at a locus where because fiat money has no meaning they can extract arbitrary amounts of it. It is an infinite money glitch in the fiat game. Turing Pharmaceuticals isn't even the most outrageous example of entrepreneurial minded persons exploiting the FDA for money amplification purposes.

Back in 2009 and 2010 a firm called URL Pharma managed to gain FDA approval to treat gout with colchicine. Colchicine, a product of the Autumn Crocus, has a recorded history of use in treating gout that stretches back roughly 3500 years with pharmaceutically pure forms of colchicine becoming available in the 1820s. Overnight the blessing of exclusivity from regulators raised the price of this drug more than a hundred fold to around five United States dollars per pill. Products featuring colchicine in combination with other drugs that had previously received FDA approval were unaffected, but colchicine as a standalone product is now under patent in the United States until 2029.

  1. trade name Daparim, released in 1953  

  2. Because in spite of prices being involved, this is the furthest thing from an actual market possible  

  3. Many other antimalarials are available which are used successfully in treating toxoplasmosis which have not been affected by Turing Pharmaceuticals' re-pricing of pyrimethamine  

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