Many people assume FDA considers the VALUE of new drugs as part of their drug approval process
July 2013
Many people assume FDA considers the VALUE of new drugs as part of their drug approval process.
But they don't. By law, FDA only considers safety and efficacy...NOT the drug's cost or whether it's needed. FDA can't take into account whether we really need an 8th statin...or a 9th ARB.
This explains why manufacturers often try to protect their patents with new drugs that are only a slight twist on existing products.
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