Gottlieb: Brand Industry 'Gaming' Tactics Have Shifted
Former FDA Commissioner Sees Shift From Regulatory To Commercial Space
US FDA's focus on areas such as REMS abuse may have prompted certain brand sponsors to shift their focus to the commercial space to keep generic competition off the market, former commissioner Scott Gottlieb tells the Association for Accessible Medicines.
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Updated numbers from the US FDA's REMS abuse website show that Celgene has received two additional safety determination letters, raising question's about whether the public list has changed the practices of brand companies hindering generic company access to samples.
AAM President Davis contends he hasn't seen any evidence showing that reference listed drug access inquiries webpage has changed innovator behavior.
Other sponsors could be using tactics other than REMS abuse to game the system, US FDA Commissioner Scott Gottlieb says.