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USFDA hike drug Application by 30%

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The US Food and Drug Administration (USFDA) has hiked the fee for Abbreviated New Drug Applications (ANDAs) to $76,030 from $58,730 currently i.e by up to 30%. Such a move may hit Indian drug makers hard, which account for a major chunk of generic medicines sold in the US. These fees are effective from October 1, 2015, and will remain in effect through September 30, 2016.

According to a notification issued by the drug regulator, fee for Drug Master File (DMF) will also be costlier by over 20% while fees for inspecting domestic and foreign API and FDF facilities will be slightly reduced. The reduction of fees for facility inspection of foreign companies will encourage more firms to opt for audit of their facilities by the regulator.

FDA further said, “Fees for ANDA, PAS and DMF will increase in FY16 over the corresponding fees in FY15 due to a drop in the number of submissions in each of those three categories over the course of 2014-15. The fees for all types of facilities will decrease in FY16 over the corresponding fees in FY15 due to an increase in the number of facilities that self-identified for FY16”.

Furthermore, when an ANDA or PAS is refused in certain circumstances, a partial refund may be possible. If the reason for refusal is not related to failure to pay fees, then 75% of the fee paid will be refunded to the applicant, the regulator said.

Effects

Despite several requests from the Indian pharma industry, which plays a vital role in the generic drug market in the US, the FDA has raised the user fee and due to that small players will face tremendous difficulty from now on.