FDA User Fee Hearing Hijacked By US Health Care Reform Arguments
Executive Summary
Democrats argue generic competition alone cannot fix drug pricing problem as senators attempt to pull FDA into Obamacare repeal and replace debate.
You may also be interested in...
US Generic Reviews: Would Pre-Submission Meetings Be Better Than Six-Month Priority Review?
Lawmakers inquire about expanding pre-submission meetings to include non-complex priority ANDAs, suggesting it could be another way to help deal with drug pricing issues.
REMS Reform Seems Distant Goal For Generics After Limited Support At US House Hearing
Although panelists expressed concerns about REMS misuse as barrier to competition, Republicans did not appear interested in the topic.
Bill To Speed ANDA Approvals Gets Cool Reception From Industry, US FDA
At House hearing, FDA and AAM highlight logistical challenges of legislation's six-month ANDA review goal and potential to put GDUFA II agreement at risk.