Amendment added during markup would require eight-month review of ANDAs for shortage drugs and those with limited competition, as well as pre-submission meetings.
Legislation expanding the US FDA's generic drug priority review pathway beyond sole-source drugs to generics entering markets with "limited competition" was added to the Senate's user fee reauthorization bill.
The Senate Health, Education, Labor and Pensions Committee overwhelmingly approved the amended FDA Reauthorization Act 21-2 on May 11, sending it to the Senate floor for final consideration
Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.
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.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
