FDA Unveils User Fee Rates for FY 2017

Regulatory NewsRegulatory News | 01 August 2016 |  By 

In the late 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, but for the US Food and Drug Administration (FDA) itself.

The problem, FDA argued, was that the agency lacked adequate funding to hire the staff it needed to review drugs in a timely manner. The solution FDA proposed was to collect fees from the companies it regulates for each new product, which would provide the agency with a substantial source of funding to boost its staff and reduce review times.

Eventually, this led to the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, which authorized FDA to collect such fees for its review activities in return for a speedier, more predictable review process.

Since then, Congress has reauthorized the user fee acts to enable FDA to collect fees for other regulated products, including medical devices, biosimilars, and generic and animal drugs.

FY 2017 Fees

For FY 2017, FDA has lowered most of its application fees, while increasing some of its other fees, such as facility fees for certain products.

For new drugs and biosimilars, fees are down across the board from 2016, and are at their lowest point since FY2013. For new drug applications requiring clinical data, FDA has lowered the fee by more than $300,000, from $2,374,200 in FY2016 to $2,038,100 in FY2017.

Medical device makers will also get a significant break on fees in FY2017, with nearly all fees down to their lowest point under the 2012 Medical Device User Fee Amendments (MDUFA II). FDA on Monday also released new guidance on small business qualification and certification.

For generic drugmakers, FY 2017 fees will be slightly lower than in FY 2016, though fees for drug master files, finished dosage forms and active pharmaceutical ingredients have all increased.

Prescription Drug User Fee Act (PDUFA)201720162015
New Drug Application (With Clinical Data)$2,038,100$2,374,200$2,335,200
New Drug Application (Without Clinical Data)$1,019,050$1,187,100$1,167,600
New Drug Application Supplement With Clinical Data$1,019,050$1,187,100$1,167,600
NDA Establishment$512,200$585,200$569,200
Annual Product Registration$97,750$114,450$110,370
Medical Device User Fee Act (MDUFA) [Small Business]201720162015
Premarket Application$234,495 [$58,624]$261,388 [$65,374]$250,895
Product Development Protocol$234,495 [$58,624]$261,388 [$65,374]$250,895
Biologics Licensing Application$234,495 [$58,624]$261,388 [$65,374]$250,895
Premarket Report$234,495 [$58,624]$261,388 [$65,374]$250,895
BLA Efficacy Supplement$234,495 [$58,624]$261,388 [$65,374]$250,895
Panel-Track Supplement$175,871 [$43,968]$196,041 [$49,010]$188,171
180-Day Supplement$35,174 [$8,794]$39,208 [$9,802]$37,634
Real-Time Supplement$16,415 [$4,104]$18,297 [$4,574]$17,563
510(k) Premarket Notification Submission4,690 [$2,345]$5,228 [$2,614]$5,018
30-Day Notice$3,752 [$1,876]$4,182 [$2,091]$4,014
513(g) Request for Classification Information$3,166 [$1,583]$3,529 [$1,765]$3,387
Annual Fee for Class III Device$8,207 [$2,052]$9,149 [$2,287]$8,781
Annual Establishment Registration$3,382 [$3,382]$3,845 [$3,845]$3,646
Generic Drug User Fee Act (GDUFA)201720162015
Abbreviated New Drug Application$70,480$76,030$58,730
Prior Approval Supplement$35,240$38,020$29,370
Drug Master File$51,140$42,170$26,720
Finished Dosage Form Facility (Domestic)$258,646$243,905$247,717
Finished Dosage Form Facility (Foreign)$273,647$258,905$262,717
Active Pharmaceutical Ingredient Facility (Domestic)$44,234$40,867$41,926
Active Pharmaceutical Ingredient Facility (Foreign)$59,234$55,867$56,926
Biosimilar User Fee Act (BsUFA)201720162015
Biosimilar Application (Requiring Clinical Data)$2,038,810$2,374,200$2,335,200
Biosimilar Application (Not Requiring Clinical Data)$1,019,050$1,187,100$1,167,600
Biosimilar Supplement (Requiring Clinical Data)$1,019,050$1,187,100$1,167,600
Biological Product Development (Initial)$203,810$237,420$233,520
Biological Product Development (Annual)$203,810$237,420$233,520
Biological Product Development (Reactivation)$407,620$474,840$467,040
Establishment Fee$512,200$585,200$569,200
Product Fee$97,750$114,450$110,370
Animal Drug User Fee Act (ADUFA)201720162015
Animal Drug Application (New)$350,700$351,100$400,600
Animal Drug Application (Supplement)$175,350$175,550$200,300
Animal Drug Product Fee$8,195$7,790$8,075
Animal Drug Establishment Fee$111,900$105,950$104,150
Animal Drug Sponsor Fee$103,100$101,000$94,450
Animal Generic Drug User Fee Act (AGDUFA)201720162015
Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4)$232,400$233,300$189,200
Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4)$116,200$116,650$94,600
Generic New Animal Drug Product Fee$10,200$8,705$8,500
Sponsor Fee (Seven or More Approved Products)$96,350$83,800$80,900
Sponsor Fee (Three or More Approved Products)$72,263$62,850$60,675
Sponsor Fee (One or Fewer Approved Products)$48,175$41,900$40,450
Outsourcing Facility Fee201720162015
Qualified Small Business Establishment Fee$5,279$5,203$5,103
Non-Small Business Establishment Fee$16,852$16,465$16,442
Reinspection Fee$15,837$15,610$15,308


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