The FDA is trying again to obtain user fees for INDs, in this case $150,000 per year for biosimilar INDs.
http://www.gpo.gov/fdsys/pkg/FR-2011-05-10/pdf/2011-11348.pdf Couple of comments:
1- Once the primary IND is cleared, I'd be real curious to know it can cost $150,000/yr for the agency to maintain the IND. If your IND is on full/partial hold, if you are in Phase III with multiple/complex indications, then I can imagine a cost $150,000/annum, but that would be exception, not the rule. Given that biosimilars are going to be easier (not easy, but easier) than a BLA or an NDA for a new molecule, I wonder what the FDA thinks it can charge per annum for that kind of IND? $250,000/annum? $500,000/annum?
2- Three years from clearing the IND to approval? I do not doubt that can be done; to think though this would be the average time when there is no current record to rely on is, well, I was going to say optimistic, but then again, perhaps the FDA just understands the obvious: with this user fee in place, everyone is gong to maximize sourcing the data from elsewhere and absolutely minimize any and all studies in the US. I'd probably try to file my IND the same year as my commercial application, and get agency feedback up front. Still would cost, but by this time, at least I would have a much better understanding if I even had a product.
3- What if an academic investigator filed for a biosimilar IND?
I am not outright opposed to fees, other regualtory jurisdictions have made fees work without impeding research, at least not obviously so. But $150,000/annum just is not a reasonable place to even start. Hopefully this proposal goes quietly away. Just wondering if anyone has any thoughts.
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Heimo Scheer PhD RAC
Vice President, Regulatory Affairs
Celerion Inc
United States
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