US pharma regulator cuts drug filing fee by 8%

Nalinakanthi V BL Research Bureau | Updated on March 09, 2018 Published on August 01, 2014

The US drug regulator, Food and Drug Administrator (FDA), has lowered the fee charged for generic drug applications by 8 per cent.

This will apply on filings made after October this year and will benefit pharma companies such as Cadila, Dr Reddy’s, Glenmark, Sun, Ranbaxy, and Lupin, which have significant presence in the US.

The FDA is authorised to collect user fee to approve certain human generic drug products. These filings can be in two categories. Those for finished formulations or abbreviated new drug applications (ANDAs) and for active ingredients called drug master files (DMFs). The revised fee for ANDAs and DMFs stands at $ 58,730 (₹35.2 lakh) and $29,370 (₹17.6 lakh), respectively.

The fee has been arrived at by estimating the FDA’s revenue and expenditure—personnel and other costs—for that year. The regulator expects to collect fee on 1,065 generic drug applications during this period. This has been derived by annualising the 1,775 filings made between October 2012 and May 2014.

Drug-makers Cadila, Dr Reddy’s and Glenmark are likely to save ₹1-1.5 crore on account of this. These companies file 30-50 ANDAs annually. Sun Pharma and Lupin, which file 20-25 products, may save ₹0.8 crore on the filings made in the 12 months beginning October 2014.

Annual facility fee

However, the FDA has increased the annual facility fee payable by drug-makers selling in the US.

Indian drug-makers will have to pay a fee of $ 262,717 (higher by about 12 per cent) in case they file ANDA from facilities located outside the US. For a US-based facility, the fee will be $247, 717; 12.5 per cent more than in the previous year. Likewise, the fee for DMF filing from non-US facilities will be $56, 926 (an increase of 15 per cent), while the same for facilities located in the US has been increased by over 21 per cent to $41, 926.

Published on August 01, 2014
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