The agency was expecting many pending generic drug submissions to be withdrawn because sponsors would not want to pay the one-time backlog fee, but instead saw a substantial increase near the end of FY 2012.
It appears FDA’s generic drug application backlog did the exact opposite of what the agency hoped when it asked sponsors to voluntarily withdraw inactive or unnecessary submissions.
Rather than decrease or plateau from the 2,500 submissions that were pending at the end of fiscal year 2011, the backlog increased more than 16%
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.
HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.
