The FDA just unveiled its new, pricier fee schedule to review new drugs

With the new user fee deals signed into law, the FDA unveiled a new increased fee schedule that will apply to biopharmaceutical companies for their prescription drug and biosimilar applications and programs.

For prescription drugs requiring clinical data, the price for FY 2018 will be about $2.4 million, which is nearly $400,000 more than in 2017. For prescription drugs not requiring clinical data, the fee will be about $1.2 million, which is about $192,000 more than 2017.

Orphan products will still be exempt from paying fees and FDA says it approximates that about 37 program fees will be exempted in FY 2018.

“The FY 2018 revenue amount may be adjusted further, if necessary, to provide for sufficient operating reserves of carryover user fees,” the FDA noted in a Federal Register notice. “Finally, the amount is adjusted to provide for additional direct costs to fund PDUFA VI initiatives. Fee amounts are to be established each year so that revenues from application fees provide 20 percent of the total revenue, and prescription drug program fees provide 80 percent of the total revenue.”


On the biosimilar side, which was aligned with fees from the Prescription Drug User Fee Act (better known as PDUFA) in the last agreement but now has its own formula, fee rates for FY 2018 include:

  • Initial biosimilar biological product development (BPD) fee: $227,213
  • Annual BPD fee: $227,213
  • Reactivation (a fee to resume participation in a discontinued program): $454,426
  • Applications requiring clinical data: $1,746,745 (which is about $292,000 less than 2017)
  • Applications not requiring clinical data: $873,373 (which is about $146,000 less than 2017)
  • Program fees: $304,162

“The initial BPD fee for a product is due when the sponsor submits an IND that FDA determines is intended to support a biosimilar biological product application for the product or within 5 calendar days after FDA grants the first BPD meeting for the product, whichever occurs first,” the agency said in a notice.

In late August, the regulator also unveiled the medical device and generic drug user fees.

First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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