Will This Bill Relieve 'Hardship' Caused By Generic User Fees?

Nearly two years ago, the FDA was granted authority to charge user fees to generic drugmakers in hopes of accomplishing two pressing goals – bolstering oversight of the pharmaceutical supply chain by underwriting the cost of additional plant inspections and tackling a growing backlog of applications for approvals. But the effort has generated considerable grumbling. As expected, there was a recent a rise in user fees, since there is a projected decline in the number of abbreviated new drug applications to be filed and there are fewer facilities that will carry the overall burden. And fees for the recently ended fiscal year included a one-time $50 million allocation to tackle a backlog in applications, which must now be made up by future increases (more here). Some claim a financial hardship ensues. Unlike PDUFA, which permits a drugmaker to request a waiver or refund for a user fee under certain conditions, the Generic Drug User Fee Act, or GDUFA, requires yearly payments while an ANDA is pending and refunds can only be issued for payments made in error (more details here). “With median approval times at about 34 months, this may mean that three or more facility fees may be due prior to application approval,” writes Bob Pollock, a senior advisor at Lachman Consultants and a former deputy director of the FDA Office of Generic Drugs, on his blog. “At the current rate of $220,152 for domestic facilities and $235,152 for foreign facilities, that could mean close to $700,0...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs