FDA User Fee Hearing Hijacked By US Health Care Reform Arguments
Democrats argue generic competition alone cannot fix drug pricing problem as senators attempt to pull FDA into Obamacare repeal and replace debate.
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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.
Although panelists expressed concerns about REMS misuse as barrier to competition, Republicans did not appear interested in the topic.
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.