# Presentation: 317890

## UPDATE ON FACA and CDER’s Advisory Committees

**Center for Drug Evaluation and Research**
**Office of the Chief Counsel**
**US Food and Drug Administration**
**DIA Annual Meeting**
**San Diego, California**
**15 June 2000**

## AGENDA:

**Introduction:**
**Murray Lumpkin **
**Deputy Center Director (CDER)**
**Legal History and Perspective****:**
**Donna Katz**
**Office of the Chief Counsel (FDA)**
**Advisory Committee Staff Perspective****:**
**John Treacy**
**Director, Adv Cmt Staff (CDER)**** **
**Q&A / Discussion**

- Murray M. Lumpkin, M.D.

- 15 June 2000

## BACKGROUND  

**Stipulated in final court agreement between Public Citizen, FDA, PhRMA **
**11/30/99  Guidance **
**12/22/99 Guidance**
**Interpretation of Agency’s responsibilities under FACA and 21 CFR 314.430**

- Murray M. Lumpkin, M.D.

- 15 June 2000

## GUIDANCE PURPOSE  

**Clarifies**
**Open advisory committees**
**Convened by CDER**
**Starting on January 1, 2000**
**Describes CDER procedures for making info shared with committee members publicly available**
**Describes how sponsors should prepare their packages**

- Murray M. Lumpkin, M.D.

- 15 June 2000

## FDA RESPONSIBILTIES

**FDA construes the FACA to require that, with respect to any open advisory committee meeting convened pursuant to the FACA, whenever practicable and subject to any applicable exemptions of the FOIA, those materials that are provided to the members of an advisory committee in connection with that meeting must be made available for public inspection and copying before or at the time of the advisory committee meeting.**

- Murray M. Lumpkin, M.D.

- 15 June 2000

## GUIDANCE APPLICABILITY 

**Focus of meeting solely or primarily addresses an NDA, NDA supplement, or ANDA (approval or testing)**
**If BLA, PLA that is segregable -  ****NO**
**If combination with NDA - ****YES**
**Closed - ****NO**
**Other Centers - ****NO**

- Murray M. Lumpkin, M.D.

- 15 June 2000

## SPONSOR SUBMISSIONORGANIZATION

**Fully Releasable Sponsor Submission**
**Sponsor Submission with materials the sponsor believes should be redacted**
**Incentives for the former:**
**May submit closer to adv cmt meeting**
**Doesn’t result in extension of review clock (priority review)**

- Murray M. Lumpkin, M.D.

- 15 June 2000

## SPONSOR SUBMISSIONORGANIZATION

**Segregate material to be redacted or put in special type face**
**Clearly designate the material the sponsor believes is exempt**
**Provide detailed justification of why they think it is exempt from disclosure under FOIA**

- Murray M. Lumpkin, M.D.

- 15 June 2000

## DISCLOSABLE MATERIALS 

**Summaries of tables of S&E data**
**Summaries of non-clinical S&E data**
**Summaries of sADRs**
**Statistical summaries of S&E data**
**Clinical or preclinical protocols**
**Copies of slides to be presented by sponsor**
**Names of principal investigators**
**Proposed I&U, D&A, safety parts of label**

- Murray M. Lumpkin, M.D.

- 15 June 2000

## NON-DISCLOSABLE MATERIALS

**Product formulation or other CMC info**
**Full reports of raw clinical or preclinical data**
**Reports of unpublished studies**
**Lists not exhaustive or absolute**
**Broad guidance**

- Murray M. Lumpkin, M.D.

- 15 June 2000

## PROMOTIONAL PACKAGES 

**Cautions that packages should only address issue before committee**
**Statements that are misleading or promotional are inappropriate for inclusion**
**FDA may post a correction on Web site**
**Disclaimer on CDER Web site:**
**The statements contained in this document are those of the product’s sponsor, not FDA, and FDA does not necessarily agree with the sponsor’s statements.  FDA has not made a final determination about the safety or effectiveness of the product described in this document.**

- Murray M. Lumpkin, M.D.

- 15 June 2000

## TIMELINES

**These dates are in stone**
**Failure of sponsor or FDA to meet date for submission of materials to ACS means that the materials WILL NOT be shipped to the advisory committee members.**
**Days are BUSINESS DAYS.**
**Sponsor submission of a redactable packages will add 2 months to user fee action deadline if PRIORITY review.**

- Murray M. Lumpkin, M.D.

- 15 June 2000

## EFFECT ON USE FEE ACTION CLOCK:

- 0

- 1

- 2

- 3

- 4

- 5

- 6

- 7

- 8

- 9

**Action**
**Date**

**Adv**
**Cmt**

**Sponsor & FDA**
**Submissions**
**To AC next day**

**ID**
**Issues**

**File**

**EFFECT ON USE FEE ACTION CLOCK:**
**SPONSOR - Non-redacted package**
**10 MONTH REVIEW CLOCK**

- 10

- 11

- 12

- Murray M. Lumpkin, M.D.

- 15 June 2000

## EFFECT ON USE FEE ACTION CLOCK:

- 0

- 1

- 2

- 3

- 4

- 5

- 6

- 7

- 8

- 9

**Action**
**Date**

**Adv**
**Cmt**

**ID**
**Issues**

**File**

**EFFECT ON USE FEE ACTION CLOCK:**
**SPONSOR - Redacted package**
**10 MONTH REVIEW CLOCK**

- 10

- 11

- 12

**Sponsor**
**Initial**
**Package**

**Sponsor**
**Final Pckg**
**& FDA Pckg**
**to Adv Cmt**

- Murray M. Lumpkin, M.D.

- 15 June 2000

## EFFECT ON USE FEE ACTION CLOCK:

- 0

- 1

- 2

- 3

- 4

- 5

- 6

- 7

- 8

- 9

**Action**
**Date**

**Adv**
**Cmt**

**Sponsor & **
**FDA**
**Submissions**
**to AC next**
**day**

**ID**
**Issues**

**File**

**EFFECT ON USE FEE ACTION CLOCK:**
**SPONSOR -  Non-redacted package**
**PRIORITY - SIX MONTH REVIEW**

- Murray M. Lumpkin, M.D.

- 15 June 2000

## EFFECT ON USE FEE ACTION CLOCK:

- 0

- 1

- 2

- 3

- 4

- 5

- 6

- 7

- 8

- 9

**Action**
**Date**

**Adv**
**Cmt**

**Sponsor Final**
**& FDA**
**Submissions**
**to AC next**
**day**

**ID**
**Issues**

**File**

**AC Ext**

**EFFECT ON USE FEE ACTION CLOCK:**
**SPONSOR -  Redacted package**
**PRIORITY - SIX MONTH REVIEW**

**Sponsor**
**Initial**
**Submission**

- Murray M. Lumpkin, M.D.

- 15 June 2000