When GDUFA was signed into law this summer it included a requirement that drugmakers with an abbreviated new drug application (ANDA) that had not been tentatively approved by October 1, 2012 pay a share of a $50m backlog fee unless they withdrew their applications in writing by September 28.
Companies that failed to withdraw or pay this fee would not be able to submit any new ANDAs for generic drugs or any prior approval supplements (PAS), which are used to notify the agency of changes to manufacturing processes.
In late October, the Food and Drug Administration (FDA) announced that it had a backlog of 2,868 ANDA applications and requested that each applicant pay a $17,434 share of the backlog fee by November 26.
Last week the agency posted an updated roll call of manufacturers that missed the deadline and reiterated that until they pay up it would not be able to accept any new applications or updates.
Back log
The imposition of backlog fees under GDUFA is part of the FDA’s wider effort to reduce the number of ANDA applications awaiting review, which has increased from around 1,000 in 2006.
This work began in June when the agency signalled its intention to deem any application submitted to it by an organisation with which it has not been in contact since July 8,1991 as having been withdrawn voluntarily unless otherwise notified by the applicant.
But while this decision removed some 364 applications from the review list, the FDAs other efforts to reduce its regulatory workload – including the backlog fee – have been less successful.
According to FDAlawblog.net post by October only a few of the backlog ANDAs had been withdrawn.