FDA Publishes All User Fee Rates for Fiscal Year 2014
The US Food and Drug Administration (FDA) has just published the user fee rates set to go into effect for the coming 2014 fiscal year (FY), including those for pharmaceuticals, biosimilars, facilities, master files, generic drugs and medical devices.
Background
Since the early 1990s, FDA has become increasingly reliant upon user fees to fund its operations. Whereas before the agency relied almost entirely on federal funding to conduct its operations, now nearly all industries regulated by FDA pay the agency under various user fee agreements, and do so willingly.
Most industries also negotiate these fees directly with the agency, resulting in user fee legislation that is submitted by FDA to Congress, albeit in draft form. Many industries are also broadly in favor of the fees, as they generate a greater return on investment by permitting a more expeditious regulatory process. For example, under the Prescription Drug User Fee Act (PDUFA), now in its fifth iteration, each new drug application submitted to FDA is submitted along with a substantial user fee. This permits FDA to hire more staff, allowing it to review products more quickly, thereby allowing the company to bring the product to market more quickly as well.
Since the 1992 passage of PDUFA, Congress has passed many other user fee acts covering medical devices, generic drugs, veterinary drugs, biosimilars and food products, as well as related inspection and registration activities.
User Fees at a Glance
The agency is now out with several documents outlining the fees expected to be paid members of the life science industry for covered activities during FY 2014.
Activity | Standard Fee | Small Business Fee |
New Drug Application (With Clinical Data) | $2,169,100 | |
New Drug Application (Without Clinical Data) | $1,084,550 | |
New Drug Application Supplement With Clinical Data | $1,084,550 | |
NDA Establishment | $554,600 | |
Annual Product Registration | $104,060 | |
Premarket Application | $258,520 | $64,630 |
Product Development Protocol | $258,520 | $64,630 |
Biologics Licensing Application | $258,520 | $64,630 |
Premarket Report | $258,520 | $64,630 |
Panel-Track Supplement | $193,890 | $48,473 |
180-Day Supplement | $38,778 | $9,695 |
Real-Time Supplement | $18,096 | $4,524 |
510(k) Premarket Notification Submission | $5,170 | $2,585 |
30-Day Notice | $4,136 | $2,068 |
513(g) Request for Classification Information | $3,490 | $1,745 |
Annual Fee for Class III Device | $9,048 | $2,262 |
Annual Establishment Registration | $3,313 | $3,313 |
Abbreviated New Drug Application | $63,860 | |
Prior Approval Supplement | $31,930 | |
Drug Master File | $31,460 | |
Foreign Facility Fee Differential | $15,000 | |
Finished Dosage Form Facility (Domestic) | $220,152 | |
Finished Dosage Form Facility (Foreign) | $235,152 | |
Active Pharmaceutical Ingredient Facility (Domestic) | $34,515 | |
Active Pharmaceutical Ingredient Facility (Foreign) | $49,515 | |
Biosimilar Application (Requiring Clinical Data) | $2,169,100 | |
Biosimilar Application (Not Requiring Clinical Data) | $1,084,550 | |
Biosimilar Supplement (Requiring Clinical Data) | $1,084,550 | |
Biological Product Development (Initial) | $216,910 | |
Biological Product Development (Annual) | $216,910 | |
Biological Product Development (Reactivation) | $433,820 | |
Establishment Fee | $554,600 | |
Product Fee | $104,060 | |
Animal Drug Application (New) | $396,600 | |
Animal Drug Application (Supplement) | $198,300 | |
Animal Drug Product Fee | $9,075 | |
Animal Drug Establishment Fee | $105,800 | |
Animal Drug Sponsor Fee | $101,150 | |
Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4) | $177,900 | |
Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4) | $88,950 | |
Generic New Animal Drug Product Fee | $8,035 | |
Sponsor Fee (Seven or More Approved Products) | $72,800 | |
Sponsor Fee (Three or More Approved Products) | $54,600 | |
Sponsor Fee (One or Fewer Approved Products) | $36,400 | |