mdi Consultants
FDA announces the user fee rates for prescription drugs, generic drugs, biosimilars, and outsourcing facilities for FY 2020
As part of the FDA, CDER also known as the Center for Drug Evaluation and Research regulates new drugs including prescription and generic drugs, before they can be sold. The FDA is authorized to collect application fees for certain applications. The FDA announced its fee rates for FY 2020. Fees rates have been adjusted for inflation. The fee rates go into effect from October 1, 2019 to September 30, 2020. The application fee should be paid for at the time of submission to avoid delays. The fee you must pay is the fee that is in effect at the time your application is received by the FDA or the date your fee payment is recognized by the U.S. Treasury. Small businesses may qualify for a reduced fee.
Not all fees have increased or changed for FY 2020. The largest decrease to note is the 36.4% decrease of initial BPD, annual BPD, and reactivation fees for biosimilars.
Prescription Drug Fees for FY 2020:
| Fee category | Fee rates for FY 2020 |
| Application: | |
| Requiring clinical data | $2,942,965 |
| Not requiring clinical data | 1,471,483 |
| Program | 325,424 |
Application fees increased 13.7% and program fees increase 5.1% from FY 2019.
Generic Drug Fees for FY 2020:
| Fee category | Fees rates for FY 2020 |
| Applications: | |
| Abbreviated New Drug Application (ANDA) | $176,237 |
| Drug Master File (DMF) | 57,795 |
| Facilities: | |
| Active Pharmaceutical Ingredient (API) Domestic | 44,400 |
| API—Foreign | 59,400 |
| Finished Dosage Form (FDF)—Domestic | 195,662 |
| FDF—Foreign | 210,662 |
| Contract Manufacturing Organization (CMO)—Domestic | 65,221 |
| CMO—Foreign | 80,221 |
| GDUFA Program: | |
| Large size operation generic drug applicant | 1,661,684 |
| Medium size operation generic drug applicant | 664,674 |
| Small business operation generic drug applicant | 166,168 |
Application fees actually only decreased by 1.4% for ANDAs and increased by 5.1% for DMFs when compared to FY 2019 fee rates. Facility fees for generic drugs for domestic APIs increased by .4% while foreign APIs only increased by .3%, domestic FDFs fees decreased by 7.4% while foreign FDFs decreased by 7%. Domestic CMO fees have also decreased by 7.4% while foreign CMO fees have decreased by 6.1%. All GDUFA program fees significantly decreased by a little over 10%.
| Fee category | Fee rates for FY 2020 |
| Initial BPD* | $117,987 |
| Annual BPD* | 117,987 |
| Reactivation | 235,975 |
| Applications: | |
| Requiring clinical data | 1,746,745 |
| Not requiring clinical data | 873,373 |
| Program | 304,162 |
*BPD-biological product development
Initial BPD, annual BPD, and reactivation fees have dramatically decreased by a whopping 36.4%! Biosimilar application and program fees have not changed since FY 2019.
| Fee category | Fee rates for FY 2020 |
| Qualified Small Business Establishment Fee | $5,599 |
| Non-Small Business Establishment Fee | 18,288 |
| Re-inspection Fee | 16,798 |
Outsourcing facility fees for small businesses and re-inspection fees have increased by 2.5% while non-small business establishment fees have only increased by .5%.
mdi Consultants has been involved with many clients on various projects and specializes in dealing with applications like PMAs, ANDAs, reports and other FDA documentation. mdi has successfully submitted and cleared thousands of FDA drug applications allowing mdi to stand out as one of the leading regulatory experts in the country. If you need any assistance with FDA applications or other regulations, please contact us for a free consultation.
We will continue to monitor any updates pertaining to CDER user fee rates moving forward. If you have any questions about fee rates and the FDA, how this can affect your company, or for any of your regulatory requirements feel free to contact us at [email protected] or use our contact form.