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FDA Generic Drug User Fees

Money QuestionHaving just returned from the DCAT meeting in New York City, all the buzz was about the seemingly imminent "Generic Drug User Fees."  Everyone had questions, opinions, suggestions and speculated about the upcoming fees. The main questions were how big the fees would be (especially from smaller companies with limited resources), the impact the fees would have on ANDA approval times and when they would start.  It seems everyone had a different answer or idea for the various questions. I heard people discuss feels as small as $20,000 per ANDA to upwards of $100,000 per ANDA.  Timelines seemed to range from sometime during the second quarter of 2011 to sometime in 2012.  Nobody had an answer to the impact that the fees would have on approval timelines but consensus seemed to be that a target of 18 month approvals would be ideal.  The only thing that wasn't in question was whether or not the fees would happen.  Everyone agreed that they would happen and most were optimistic to their success.

User fees have been implemented with varying success at the difference divisions at FDA.  CDER has implemented PDUFA fees for NDA submissions with success in sticking to the review times in most instances.  However, if you read the statistics regarding the decreasing number of new drugs being approved, the real question revolves around the cause of the timelines being kept is it due to the number of filings or due to the fees.  Additionally, PDUFA fees for NDA are very large and have created a secondary issue.  The FDA would love to remove all unapproved "Grandfathered" products from the market, however the large PDUFA fees make it cost prohibitive to submit an NDA for these products. 

On the other side of the coin, CVM has issued reasonably sized filing fees for veterinary drug products but has placed the money in the general reserve fund (or at least so I have been told) and therefore approval times have not improved since implementing the fees.  From what I hear,  CVM makes OGD look good with the 30 month ANDA approval times.

One other question that poses itself is how do you address, the more than 2,000 ANDA that are currently backlogged once the fees start.  Do they keep their place in line or do the get bumped for "priority" paid submissions.A definite concern on industry is if the fees are used to supplement or replace the current Federal Government's funding for OGD.  If it replaces, I do not think things will get better quickly if ever.  If it supplements the fees, then I think eventually we will get to a much better system wherein timely approvals are possible and to be expected.

In conclusion, it seems not matter what the FDA does, the problem will not be solved overnight.  And if you read my previous blog; in Custopharm's opinion one of the primary reason for much of this backlog is poorly written applications that recirculate through the FDA over and over again.

We welcome any comments, thoughts, opinions and theories you may have on this subject matter.  Please feel free to comment in the space below.

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