Generic user fees have been discussed for some time. The fees are viewed as a mechanism to allow generic producers to pay for more expedited review of generic drugs for marketing approval and thus relieve a healthy back log that has built up at the FDA.
For some perspective, review time for generic drug applications in 2006 averaged 16 months versus an blossuming 29 months in 2009. Not exactly a process improvement eh? And, the FDA says there are more than 2000 applications pending at present.
But is this the biggest priority at the FDA? The FDA appears more focused on being able to increase its number of inspections of producing plants - particularly outside the US. The agency has hinted at taking "user fee" money to subsidize this latter activity. So is the agency holding user fees/expedited review hostage to concept of allocating some of these fees to support an enhanced inspection program?
Based on comments by CDER Director Janet Woodcock in hearing last week, one would conclude - Yes. The Director was lobbying hard for enhanced inspections as being good for everyone in the generic industry - as "one bad event" could spoil the industry's reputation - said reputation being good in general.
The generic producers seem by and large willing to accept the trade off -- anything to get their products reviewed and approved more rapidly! The exception may be Mylan - which stood alone from its Industry peers - and promoted the concept of having separate fees for establishment, product, and inspections. Basically paying for what you need.
Negotiations between the stakeholders will continue through the balance of the year to reach some kind of concensus on the program. Then it still would need to go through Congress.
Posted by Bruce Lehr September 24th 2010.