Retroactive FDA Review Causes Huge Price Increases in Generics

The idea of FDA going back to do safety and efficacy testing on grandfathered old remedies that have been on the market prior to modern FDA testing sounds good. However, this FDA program which began in 2006 has had the massive side effect of suddenly making many old, inexpensive generic drugs very expensive. One egregious example of such price spikes is that “Colchicane 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…. Companies that do the tests are rewarded with licenses that can temporarily give them monopoly pricing power as most rivals are eased or kicked off the market. (See Bloomberg).

This FDA program may have made some old drugs a bit safer or established that some alternative is a bit more effective, but these were drugs that had been on the market for a very long time, without significant problems. In many cases, the program for testing these old drugs “almost had the opposite effect as intended” and “The only drugs that got studied are the ones that don’t have a problem,”  according to Joseph Biskupiak, a professor at the University of Utah College of Pharmacy.

Consumers who were using inexpensive generic drugs that are reviewed under this program are likely to have to pay a lot more, try another alternative that FDA hasn’t yet reviewed, or one that FDA approved long enough ago that its price has had time to go down.

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