Posted by Michael Wonder on 10 Jun 2017
Trump's FDA stirs a generic drug storm
10 June 2017 - The pricing pressure has only just begun for some drug makers.
After repeatedly sounding off on prescription-drug prices, President Donald Trump -- who these days has other things on his mind -- has gone largely quiet on the matter. But his FDA commissioner Scott Gottlieb is keeping the topic alive.
In his initial remarks to FDA staff in May, Gottlieb suggested pricing would be an area of focus for the agency. He added specifics to that this week, telling Bloomberg News how the FDA will change the generic-drug approval process with an eye toward lowering prices.
Gottlieb's move Thursday afternoon to request that Endo International PLC pull the opioid Opana ER from the market because it is frequently abused -- a first for the agency -- suggests drugmakers should take the potential for a more-aggressive FDA seriously.
