Posted by Michael Wonder on 27 Sep 2016
A drug cartel at the FDA
26 September 2016 - A new rule will produce a lawsuit rush and raise prices for generics.
The anaphylactic political shock over EpiPen prices continues, and last week a House committee dragged in the company CEO. But some outrage should land on the FDA, which won’t approve a generic stinger that would end Mylan’s monopoly power. Instead, the agency is finishing regulation that will restrict competition precisely as patients are demanding cheaper medicines.
The FDA will next year complete a new rule on labeling generic drugs, which are chemically no different from brand-name versions but sell at an average 80% discount.
One reason generics are so much cheaper is that the drugs are approved under an expedited FDA process and bear identical labels to branded equivalents—side effects and so on. The FDA would allow generic producers to alter their own labels to include “up-to-date” safety risks, as the agency puts it.
