# Presentation: 082226

## EXPEDITED DEVELOPMENT AND REVIEW INIATIVES -FDA PERSPECTIVE

**Murray M. Lumpkin, M.D.**
**Deputy Center Director**
**Center for Drug Evaluation and Research**
**US Food and Drug Administration**
**DIA Annual Meeting**
**San Diego, California**
**12 June 2000**

## EXPEDITEDDEVELOPMENT AND REVIEW:4 MAJOR INITIATIVES

**Subpart E**
**Accelerated Approval  (Subpart H)**
**Priority Review**
**Fast Track**
**Fast Track Program**
**Fast Track Product**
**Different schemes**
**Don’t use terms interchangably**

- Murray M. Lumpkin, M.D.

- 12 June 2000

## NEW DRUG DEVELOPMENT

**Discovery** / **Screening**

**Synthesis**
**and**
**Purification**

**Animal **
**Testing**

**Pre-clinical**
**Research**

**Avg 5-7 yrs**

**IND**

**Clinical Studies**

**Short-term**

**Long-term**

**Phase 1**

**Phase 2**

**Phase 3**

**NDA Review**

**Post-marketing**

**NDA **

**AP**

**Avg 6 - 7 yrs**

**Avg 1 yr**
**Priority 6 mo**

**Subpart E:**
**Submit NDA here**

**Accelerated Approval**:
**Submit NDA here**
**but with surrogate endpt**

**Priority Review**

**Fast Track**

- Murray M. Lumpkin, M.D.

- 12 June 2000

## FDAMA Section 112

**The Secretary shall ... facilitate the development and expedite the review of [a] drug if it is ****intended for the treatment of a serious or life threatening condition**** ****and**** ****it demonstrates the potential to address unmet medical needs for such a condition****.**

- Murray M. Lumpkin, M.D.

- 12 June 2000

## Components (4 parts)

**506(a)****	****Designation of a Drug**
**506(b)****	****Approval of Application**
**Based on clinical endpoints or surrogate endpoints**
**Limitations**
**506(c)****	****Review of Incomplete Applications**
**506(d)****	****Awareness Efforts**

- Murray M. Lumpkin, M.D.

- 12 June 2000

## FAST TRACK PROGRAM:FIRST QUESTIONS

**Are you eligible for fast track designation?**
**Guidance for Industry: Fast Track Drug Development Programs - Designation, Development and Application Review    Sept 1998**
**Are you eligible for other regulatory options: accelerated approval, priority review, Subpart  E approval**

- Murray M. Lumpkin, M.D.

- 12 June 2000

## FAST TRACK ALGORITHM

**serious or life-threatening?**

**No**

**Not FT**

**Yes; possibly FT**

**Does the drug show potential to treat**
**a serious aspect of the condition?**

**No**

**Not FT**

**Yes, possible FT**

**Is the drug development program designed**
**to determine whether the drug will effect**
**a serious aspect of the condition?**

**No     Not FT**

**Yes, possible FT**

**FAST TRACK ALGORITHM**

- Murray M. Lumpkin, M.D.

- 12 June 2000

## FAST TRACK ALGORITHM

**serious or life-threatening aspect of the**
**condition being studied?**

**No**

**Yes, possibly FT**

**Is a medical need unmet by**
**available treatments**

**No**

**Not FT**

**Yes, possibly FT**

**Is that unmet medical need being**
**studied with this product?**

**No**

**Not FT**

**Yes**

**FT**

**FT**

**FAST TRACK ALGORITHM**

- Murray M. Lumpkin, M.D.

- 12 June 2000

## FAST TRACK

**Multiple meetings ****(pre-IND through labeling discussions)**
**Possible Accelerated Approval (surrogate endpoint) **
**Possible approval under Subpart E (less safety data than normal; P2)**
**Priority review designation**
**Portion of an application eligible for early submission**

- Murray M. Lumpkin, M.D.

- 12 June 2000

## ROLLING REVIEW

**Caveats**
**Review complete portions of an NDA**
**Filing awaits complete application**
**Scheduling of review TBD by division**
**User fee must be paid with first portion**
**Review clock starts with complete NDA**
**Eligibility for Priority Review and Accelerated Approval (unlinked)**
**Efficacy standard in 505(d) (unlinked)**

- Murray M. Lumpkin, M.D.

- 12 June 2000

## EXPERIENCE in 1st YEAR

**CDER**
**51 requests (32 granted; 12 denied; 7 open)**
**Approximately 20 indications**
**All CDER ODEs represented**
**CBER**
**30 requests (ratio similar to CDER)**
**Approximately 20 indications**

- Murray M. Lumpkin, M.D.

- 12 June 2000

## SELECTED INDICATIONS

**CDER**
**Coronary syndrome**
**CVA**
**ALS**
**Malignancies**
**Acute pancreatitis**
**Platelet adhesion**
**HIV**
**SLE**
**ARDS**
**Acromegaly**

**CBER**
**Advanced RA**
**Malignancies**
**Fabry’s Disease**
**Critical limb ischemia**
**Muscular dystrophy**
**Hepatic failure**
**Crohn’s disease**
**HIV**
**SLE**
**Multiple Sclerosis**

- Murray M. Lumpkin, M.D.

- 12 June 2000

## SUMMARY

**To Qualify**
**Intended to treat a serious disease**
**Has the potential to address an unmet medical need**
**Development plan evaluates that potential**
**506 adds SoPA to existing programs (including PR and AA)**
**Guidance is comprehensive resource**

- Murray M. Lumpkin, M.D.

- 12 June 2000