GDUFA II User Fees. Update on Implementation

Transcription

1 GDUFA II User Fees Update on Implementation Donal Parks, Director Division of User Fee Management and Budget Formulation OM CDER US FDA November 8, 2017

2 Outline Refresher on GDUFA II fee structure What stays the same What is new and different Preparations for GDUFA II fees Contract Manufacturing Organization (CMO) facility fee Generic Drug Applicant Program Fee (program fee) Implications for future years 2

3 Where We Ended GDUFA I Fee Type Target Percentage Total Target Revenue ANDA / PAS 24% $77,523,000 API Facility 14% $45,221,000 FDF Facility 56% $180,886,000 DMF 6% $19,381,000 Total: 100% $323,011,000 3

4 Where We Began GDUFA II Fee Type Target Percentage Total Target Revenue GDUFA I GDUFA II GDUFA I GDUFA II GDUFA I GDUFA II ANDA / PAS ANDA 24% 33% $77,523,000 $162,888,000 Program 35% $172,760,000 API Fac API Fac 14% 7% $45,221,000 $34,552,000 FDF Fac FDF Fac 56% 20% $180,886,000 $98,720,000 DMF DMF 6% 5% $19,381,000 $24,680,000 Total: 100% 100% $323,011,000 $493,600,000 4

5 Where We Began GDUFA II Fee Type Target Percentage Total Target Revenue GDUFA I GDUFA II GDUFA I GDUFA II GDUFA I GDUFA II ANDA / PAS ANDA 24% 33% $77,523,000 $162,888,000 Fee is due upon submission of an ANDA Withdraw before filing eligible for 75% refund State entities exempt from fee Program 35% $172,760,000 API Fac API Fac 14% 7% $45,221,000 $34,552,000 FDF Fac FDF Fac 56% 20% $180,886,000 $98,720,000 DMF DMF 6% 5% $19,381,000 $24,680,000 Total: 100% 100% $323,011,000 $493,600,000 5

6 Where We Began GDUFA II Fee Type Target Percentage Total Target Revenue GDUFA I GDUFA II GDUFA I GDUFA II GDUFA I GDUFA II ANDA / PAS ANDA 24% 33% $77,523,000 $162,888,000 Program 35% $172,760,000 API Fac API Fac 14% 7% $45,221,000 $34,552,000 Annual fee for holders of approved ANDAs FDF Fac FDF Fac 56% 20% $180,886,000 $98,720,000 DMF DMF 6% 5% $19,381,000 $24,680,000 Total: 100% 100% $323,011,000 $493,600,000 6

7 Where We Began GDUFA II Fee Type Target Percentage Total Target Revenue GDUFA I GDUFA II GDUFA I GDUFA II GDUFA I GDUFA II ANDA / PAS ANDA 24% 33% $77,523,000 $162,888,000 Program 35% $172,760,000 API Fac API Fac 14% 7% $45,221,000 $98,720,000 Together, the ANDA and Program fees under GDUFA II account for 68% of total revenue, up from 24% under GDUFA I FDF Fac FDF Fac 56% 20% $180,886,000 $34,552,000 DMF DMF 6% 5% $19,381,000 $24,680,000 Total: 100% 100% $323,011,000 $493,600,000 7

8 Where We Began GDUFA II Fee Type Target Percentage Total Target Revenue GDUFA I GDUFA II GDUFA I GDUFA II GDUFA I GDUFA II ANDA / PAS ANDA 24% 33% $77,523,000 $162,888,000 Fee due if referenced in approved application as of beginning of fiscal year Foreign facility fee differential of $15,000 Only one fee assessed Introduction of CMO fee Program 35% $172,760,000 API Fac API Fac 14% 7% $45,221,000 $98,720,000 FDF Fac FDF Fac 56% 20% $180,886,000 $34,552,000 DMF DMF 6% 5% $19,381,000 $24,680,000 Total: 100% 100% $323,011,000 $493,600,000 8

9 Where We Began GDUFA II Fee Type Target Percentage Total Target Revenue GDUFA I GDUFA II GDUFA I GDUFA II GDUFA I GDUFA II ANDA / PAS ANDA 24% 33% $77,523,000 $162,888,000 Together, facility fees under GDUFA II account for 27% of total revenue, down from 70% under GDUFA I Program 35% $172,760,000 API Fac API Fac 14% 7% $45,221,000 $98,720,000 FDF Fac FDF Fac 56% 20% $180,886,000 $34,552,000 DMF DMF 6% 5% $19,381,000 $24,680,000 Total: 100% 100% $323,011,000 $493,600,000 9

10 Where We Began GDUFA II Fee Type Target Percentage Total Target Revenue GDUFA I GDUFA II GDUFA I GDUFA II GDUFA I GDUFA II ANDA / PAS ANDA 24% 33% $77,523,000 $162,888,000 DMF fee due on first reference or request for CA Program 35% $172,760,000 API Fac API Fac 14% 7% $45,221,000 $34,552,000 FDF Fac FDF Fac 56% 20% $180,886,000 $98,720,000 DMF DMF 6% 5% $19,381,000 $24,680,000 Total: 100% 100% $323,011,000 $493,600,000 10

11 Where We Began GDUFA II Fee Type Target Percentage Total Target Revenue GDUFA I GDUFA II GDUFA I GDUFA II GDUFA I GDUFA II ANDA / PAS ANDA 24% 33% $77,523,000 $162,888,000 Finally, notice that there was a slight uptick in the size of the program Program 35% $172,760,000 API Fac API Fac 14% 7% $45,221,000 $34,552,000 FDF Fac FDF Fac 56% 20% $180,886,000 $98,720,000 DMF DMF 6% 5% $19,381,000 $24,680,000 Total: 100% 100% $323,011,000 $493,600,000 11

12 Top Challenges in GDUFA II Fees CMO Fee Not clear how many facilities would qualify Affiliations with sponsors Generic Drug Applicant Program Fee Unknown affiliations Inactive ANDAs Portfolio adjustments 12

13 CMO Fee A contract manufacturing organization is a facility that provides FDF manufacturing services under contract to ANDA holders with which it is not affiliated. The CMO fee is one-third the fee assessed to an FDF facility. 13

14 How We Estimated CMOs Pulled data from Integrity Services (IS) Cross-checked with other data sources Facility Self-Identification data GDUFA I payment data FDA Establishment Identifier (FEI) information Facility history report 14

15 So What Did We Come Up With? As published in the Federal Register on August 29, 2017 Domestic CMO 71 Foreign CMO 97 Total Fees were calculated to be Domestic CMO - $70,362 Foreign CMO - $85,362 15

16 Experience So Far Of the 168 CMO facilities we expected to see: 124 facilities incurred and paid the CMO fees 6 facilities incurred FDF fees but paid CMO fees 20 facilities incurred CMO fees but paid FDF fees 18 facilities paid CMO fees but are pending CMO validations Note: These data are as of 11/1/

17 Top Challenges in GDUFA II Fees CMO fee Not clear how many facilities would qualify Affiliations with sponsors Generic Drug Applicant Program Fee Unknown affiliations Inactive ANDAs Portfolio adjustments 17

18 Generic Drug Applicant Program Fee Each person and its affiliates will be assessed an annual fee depending on the number of approved ANDAs in its (their) combined portfolio. There are three tiers: Large: 20 or more approved ANDAs Medium: Between 6 and 19 approved ANDAs Small: Five or fewer approved ANDAs The fee for each tier differs: Large: Full fee Medium: 40% of the large fee Small: 10% of the large fee 18

19 How We Tackled It Two-Phase Approach Reach-out to industry Correct data quality issues Iterative posting of and updates to data Made adjustments for: Undeclared affiliations Inactive ANDAs Potential portfolio adjustments 19

20 What We Found Tier Raw Data After Cleanup After Adjustments Large Medium Small Total Note: The numbers in the After Adjustments column and the FY2018 fees calculated from them were published in the Federal Register of August 29,

21 How Did This Compare to Go-Live? Tier Posted FY 2018 Fees As of If We Had Known Delta Large 62 $1,590, $1,582, % Medium 52 $636, $632, % Small 258 $159, $158, % Total An estimation delta of around one-half of one percent is exceptional, and shows that the hard work of staff on both industry s and the Agency s side really paid off. 21

22 Going Forward The ANDA holder list will be updated on our website For now, updates will reflect only those changes that affect the current FY fees Next year s process will be much less work Early in calendar 2018 we will post the initial ANDA holder list April 1, 2018 is the deadline for withdrawal requests and affiliate updates August 2018 is when FY2019 fees will be posted 22

23 GDUFA User Fee Rates, FY2018 GDUFA Fee Types FY 2018 ANDA $171,823 DMF $47,829 Program Fee Facility Large Size $1,590,792 Medium Size $636,317 Small Size $159,079 Domestic API $45,367 Foreign API $60,367 Domestic FDF $211,087 Foreign FDF $226,087 Domestic CMO $70,362 Foreign CMO $85,362 Backlog $17,434 23

24 Further Information Link to FDA site where program fee data (including FY2018 fee rates) are posted: /gdufa. Link to a webinar we gave in October going over this information: Oct mp4 Recently-issued guidance on GDUFA II user fees: tion/guidances/ucm pdf Contact us at: CDERCollections@fda.hhs.gov

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