ANDA Operations UPDATE - gphaonline.org€¦ · 3 What You Will See Today: Progress • Controlled Correspondence • Cohort of Receipt Tracking • Receipts and Actions • Prior-Approval

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ANDA Operations UPDATE

Ted Sherwood Office of Regulatory Operations

Office of Generic Drugs

2016 GPhA Fall Technical Conferenece October 25, 2016

Presenter

Presentation Notes

Very simple data Who is our audience? Reg affairs folks, Marcie, Kiran, POCs for apps Check that Ted’s isn’t too complex Keith’s focus for GDUFA2: Pre-ANDA, simplify goals, expedited reviews, different fee structure

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What You Will Not See Today • Controlled Correspondence Backlog • Filing Backlog

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What You Will See Today: Progress • Controlled Correspondence • Cohort of Receipt Tracking • Receipts and Actions • Prior-Approval Supplements • Program Level Data • A Peak at the Platform • The Future

4

Controlled Correspondence: Stats

Fiscal Year Receipts Completed 2013 953 847 2014 1087 1237 2015 1517 1832 2016 1812 2024

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Controlled Correspondence: GDUFA Goal

6


Cohort Year 3 Application Data Commitment Goal: Act on 60% w/in 15 mons.

Current Performance for this goal 98%

Originals Received 522 Met Goal 423

Pending w/in Goal 90* Completed Overdue 5

Pending Overdue 4

*3 more months for Cohort Year 3 with pending Goal dates

RTR 70

Under Review: 12

AP or TA 33

Complete Response

254

Year 3 Original ANDAs: 369

RTR

Minor Deficiency

173

Major Deficiency

81

Under Review 32

Under Review 17

Pending Sponsor

Response 64

Amendment Submitted

64

Pending Sponsor

Response 109

Amendment Submitted

17

CR 16

AP or TA: 13

Complete Response Letters: 254

Second Cycle Actions

Year 3 Submissions: 9 Completed Months Cycle to Approval or Tentative Approval (9/30/2016)

Second Cycle Amendments

Withdrawn: 1

9

Original First Action %

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Deficiency (CR) Distribution Submission Month/ (Goal Month)

CRs Major Minor

Oct 2014/ (Jan 2016) 40 19 21

Nov 2014/ (Feb 2016) 17 5 12

Dec 2014/ (Mar 2016) 22 6 16

Jan 2015/ (Apr 2016) 13 3 10

Feb 2015/ (May 2016) 17 7 10

Mar 2015/ (Jun 2016) 37 7 30

Apr 2015/ (Jul 2016) 42 20 22

May 2015/ (Aug 2016) 41 4 37

Jun 2015/ (Sep 2016) 25 10 15

Total* 254 81 173

* 3 more months for Cohort Year 3 data still have pending Goal dates

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Amendments to Yr 3 Originals Total CRs 254

Major Submitted 17 (all pending review) Minor Submitted 62

Minor Actions 30 Minor Pending Review 32

Minor Actions 30 CR 16

Approvals 6 Tentative Approvals 7

Withdrawn 1

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“GDUFA Backlog” Applications Action through 9/30/2016

Actions ANDAs PASs

Number with First Action* 2,692 1741

Percentage Complete 94% 93% Approval 669 992

Tentative Approval 163 4

Complete Response with an Inspection** 1528 480

Refuse to Receive 68 2

Withdrawn Application 264 263

* Numbers reflect data available at the time of report publication and may change based on refreshed counts in our tracking systems, including application status updates. These numbers are not intended for Congressional reporting purposes. **Complete Response with an Inspection is a written FDA communication to an applicant usually describing all of the deficiencies that the agency has identified in an application that must be satisfactorily addressed before it can be approved.

GDUFA BACKLOG: 2,866 original ANDAs 1,876 PAS supplements GDUFA GOAL: 90% get first ACTION by end of GDUFA YR 5

(9/30/2017)

We hit 90% metric 15 months AHEAD OF SCHEDULE

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Current Year 3 Cycle Rates (9/30/2016)

First Cycle RTR Rate 20% First Cycle AP/TA Rate 8% First Cycle CR Rate 72%

Second Cycle AP/TA Rate

43%

Second Cycle CR Rate 53% Withdrawn (1) 4%

All Minor Amendment responses to date

Total Pre-Y3 Application Cohort (Since 10/1/2012)

Monthly Average (July - Sept)

FDA Snapshot

0 Pending

Filing Review

72 Filed –No Review Comm.

+ 1,372

At Least One Review Communication Issued

+

Complete Response 134

Tentative Approvals 12

Amendm

ents 85

325Info. Req. 261

Industry Snapshot

1,271 Pending Industry

Response

281 Tentative Approval

with Industry +

1,937 Approvals

Refuse to Receive 97 Resubmitted Y3/4

130 No Resubmission + 653

Withdrawals (from Cohort)

+

1,444

with FDA

=

1,552

with Industry

=

+

Current ANDA Workload of Original Applications

2,996

2,996 + = 5,813

(Status as of 10/1/2016)

Total Y3 Application Cohort (Since 10/1/2014)

FDA Snapshot

3 Pending

Filing Review


+ 156


+



Amendm

ents 14

35 Info. Req. 13 Industry Snapshot

193 Pending Industry

Response


with Industry +

20 Approvals

Refuse to Receive 32 Resubmitted in Y4

26 No Resubmission + 8


+

168

with FDA

=

215

with Industry

=

+


383

383 + = 469



Total Y4 Application Cohort (Since 10/1/2015)

FDA Snapshot

91 Pending

Filing Review


+ 279


+

Complete Response 0.3


Amendm

ents 0


8 Pending Industry

Response


with Industry +

0 Approvals

Refuse to Receive 0 Resubmitted in Y5

68No Resubmission + 5


+

633

with FDA

=

8

with Industry

=

+


641

641 + = 714



Total Applications (All Cohorts) (Since 10/1/2012)

FDA Snapshot

94 Pending

Filing Review


+ 1,807


+



Amendm

ents 98


1,472 Pending Industry

Response


with Industry +

1,957 Approvals

Refuse to Receive 224 No Resubmission + 666


+

2,245

with FDA

=

1,775

with Industry

=

+


4,020

4,020 + = 6,867



Last Month (Sept) Totals

FDA Receipts - Current

Pending Filing

Filed-No Review Comm.

>1 Review Comm. Issued

>1 Review Comm. Issued

Pending FDA

RTR CR WD TA AP RTR CR WD TA AP

Backlog 3297 0 22 3225 431 0 34 0 6 17 30 3487 481 353 1622

Year 1 1048 0 8 901 280 0 29 0 3 14 143 871 89 89 178

Year 2 1581 0 42 1391 661 0 90 1 5 13 193 803 76 45 160

Year 3 503 3 9 399 156 0 34 0 2 3 145 281 9 24 20

Year 4 849 91 263 292 279 9 2 0 0 0 280 8 5 0 0

Total 7278 94 344 6208 1807 9 189 1 16 47 791 5450 660 511 1980

Last Month

CR

CR Total

1472

Withdrawn Total 660

TA

ANDA Original Cohort Tracking Monthly Report (10/01/16)

ECDs/IRs Last Month

189 92 14 10

59 Receipts (Sept)

286 482

TA Total

303

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Approx. 1,700 ANDAs with Industry

To Industry

From Industry

Presenter

Presentation Notes

Numbers as of 8/31/16, pulled from Meeting with Senator Rand Paul and JW Senate testimony.

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21

ANDA Receipts

813 893 1103

968

1473

539 853

0

200

400

600

800

1000

1200

1400

1600

2010 2011 2012 2013 2014 2015 2016

FY16 Trends (ANDA Originals) – Actions Taken by Month (Totals)

CR

AP

TA

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ANDA Median Approval Time

19.4416.74

20.12

24.7321.56

14.84

0

5

10

15

20

25

30

FY 2010 FY 2011 FY 2012 FY 2013 FY 2014 FY 2015

Median Approval Time (fastest 5% per cohort year)

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ANDA Approvals and Tentative Approvals (Fiscal Year)

426 458 517 440 409

492 651

139 139 102

95 91

120

184

0

100

200

300

400

500

600

700

800

900

2010 2011 2012 2013 2014 2015 2016

TAsAPs

25


26

FY 16 PAS Performance: Actual

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FY 16 PAS Performance: Potential

FY16 Trends (ANDA PAS) – Actions Taken by Month (Totals)

28

CR

AP

TA

29


30

Guidance Development

31

Number of Companies (Original ANDAs)

Fiscal Year Companies Submissions 2010 163 813 2014 247 1473 2016 173 859

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ANDA Program

16,4502,300

1,450330

6,650

Original Submissions

Approved (ever)Pending FDAPending IndustryTentative ApprovalWithdrawn (not AP)

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ANDA Program

34

ANDA Workload: Pending

2800

2300

0

500

1000

1500

2000

2500

3000

Oct. 1, 2012 Sept. 1, 2016

Pending FDA

35


CR Signature Queue Approval Queue

Orig.

Supp.

Missed ? Missed ? Missed ?

Missed ?

Missed ? Missed ? Missed ?

Missed ? Missed ?

Approval Queue

Orig. Missed ? Missed ?

Is this really a miss?

What You Will See Today: Progress

• Controlled Correspondence • Cohort of Receipt Tracking • Receipts and Actions • Prior-Approval Supplements • Program Level Data • A Peak at the Platform • The Future

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The Future • Continued Progress – there is still more we need

to do and achieve • Additional Data Planned for Next Year

Documents

ANDA Operations UPDATE - gphaonline.org€¦ · 3 What You Will See Today: Progress • Controlled Correspondence • Cohort of Receipt Tracking • Receipts and Actions • Prior-Approval