FDA hikes fee for processing ANDA by USD 1 lakh for FY18

Citing high workload, the US Food and Drug Administration (USFDA) has increased the fee for processing Abbreviated New Drug Applications (ANDA) by over USD 1 lakh to USD 1.71 lakh for the fiscal year 2018.
The move will hurt the Indian pharma industry which is heavily dependent on the US market for exports, said a top official of Pharmaceuticals Export Promotion Council of India (Pharmexcil), a body under the Ministry of Commerce and Industry.
The hike was made under the Generic Drug User Fee Amendments of 2017 (GDUFA II). The fee in FY17 was USD 70,480.
According to a notification on USFDA's website, the fee for Drug Master File was reduced to USD 47,829 for 2017-18 from USD 51,140 in the last fiscal.

"The FY 2018 application fee is estimated by dividing the number of FAEs that will pay the fee in FY 2018 (948) into the fee revenue amount to be derived from ANDA application fees in FY 2018 (USD 162,888,000). The result, rounded to the nearest dollar, is a fee of USD 171,823 per ANDA," FDA said in a statement.
These fees are effective on October 1 2017, and will remain in effect through September 30, 2018.

"Though there are different categories of fee structures, definitely the hike is going to be a burden for Indian Pharma companies. However, given the potential, this would not deter us from filing ANDAs for the US market," director general of Pharmexcil, Uday Bhaskar told PTI.

According to Bhaskar, the US drug regulator cleared 598 ANDAs in 2016, out of which 201 were from Indian companies.
During the first quarter of the current calendar year, the FDA okayed 171 generic drug and 55 of them were filed by Indian companies.
However, the FDA has reduced the inspection fee for overseas Finished Dosage Firms to USD 2,26,087 from the previous USD 2,72,646.
Similarly, the inspection fee for overseas API (Active Pharma Ingredient) plants was fixed at USD 60,367 from USD 59,234 previously.
The revenue base for GDUFA II is USD 493.6 million versus USD 323 million in the final year of GDUFA I - ANDAs are the primary workload driver of the programme. GDUFA I was built on the assumption that the FDA would receive 750 ANDAs per year, the FDA said.

"Over the first four years of GDUFA I, ANDA receipts have averaged approximately 1,000 per year. To address the increased workload, FDA hired additional staff and is projected to spend about USD 430 million in the final year of GDUFA I," it said.
The GDUFA-II will be tentatively applicable till 2022.
Former president of Indian Drug Manufacturers Association S V Veeramani said with the steep increase, drug makers would think twice before they file ANDA due to the risks involved.