Budget reductions & User Fees - ANDA approval times?
Consider these points:
Compliance has 192 foreign inspections scheduled, resources to complete 62 in 2011. The number of facilities that require inspections has increased in the last 5 years. Consider only 6 years ago there were less than 20 Chinese facilities inspected and approved for API, now there are over 200. A wave of Chinese Dosage facilities have filed ANDA's which will require inspections and additional effort. Numbers in India have also grown with API manufacturers and Dosage facilities over the last 6 years. The additional overseas work created for the Compliance group is significant.
Most likely Federal funding will be cut back in 2012, talks of up to 10%.
Assuming a reduction in the number of inspections and headcount in 2012, the average ANDA approval time could continue to increase.
The possibility of User Fees for Generic applications can generate additional revenue, but will these fees be channeled directly to CDER or will a portion go to the General Accounting Fund? Additional dollars could potentially reduce the average ANDA approval times, or these fees could balance out the potential cuts to the budget.
None of us know how this will balance out next year, companies must think of ways to be most effective and efficient in order to manage the change ahead.
A key to success will be the Regulatory strategy, a 'well written' eCTD ESG ANDA will minimize the efforts of the reviewer.
Don't try to 'save money' with a low cost Regulatory Consultant, now is the time to work with an experienced company that knows what they are doing. A poorly written, poorly managed ANDA can cost a company in excess of 24 months of review time, not to mention creating an unnecessary burden on the reviewer.
Custopharm filed the first eCTD ANDA in March 2004. We have filed over 100 eCTD ANDA's, over 500 ESG filings. We file 'well written' eCTD ESG ANDA's, you can be confident that a quality application has been filed with the reviewer's needs in mind.
Best,
Dave McCleary
dmccleary@custopharm.com
