# Presentation: 280352

## OVERVIEW OF FDA’S PEDIATRIC ADVISORY COMMITTEE ACTIVITIES

- Pediatric Advisory Committee
- June 29, 2005
- Dianne Murphy, MD
- Director, Office of Pediatric Therapeutics
- OC, FDA

## Review of Pediatric Expert Panel Activities: An Evolving Process

- Pediatric Advisory Subcommittee of the Anti-infectives Advisory Committee- 1999
- Cadre of Ethicists who supplemented the Pediatric Advisory Subcommittee for specific ethical issues
- Full Pediatric Advisory Committee- 2004
- Pediatric Ethics Subcommittee- 2004
- Re-evaluation of 1-year post-exclusivity safety reporting- February 2005

## Ethical Issues

**Pediatric Advisory Subcommittee Meetings have addressed:**
**Patients vs. subjects in pediatric trials (11/15/99)**
**Placebo controlled trials (9/11/00)**
**Vulnerable pediatric populations (4/24/01)**

## Pediatric Ethical IssuesSubpart D

**September 2004**: Effects of single dose Dextroamphetamine in ADHD and functional imaging
**June 2005:** Precursor Preference in Surfactant Synthesis of Newborns

## Prior Peds AdvisorySubcommittee Discussions

_**November 1999**_: Issues regarding a Pediatric Drug Development Program for the Treatment of Insomnia
_**September 2000**_**:** Pediatric Psychotropic Drug Use Issues
_**April 2001**_**:** Treatment of Chronic Hepatitis C in Children

## Prior Peds Advisory Subcommittee Discussion (cont.)

_**March 2003**_**:** Development of Antiretroviral Drugs in HIV-Infected and HIV-Exposed Neonates Younger than four weeks of age
_**June 2003**_**:** Current Epidemiology and Therapeutic Interventions Relevant to Hyperbilirubinemia in the Term and Near-Term Newborn
_**June 2002**_**:** Reflux disease; GERD-Template

## Prior Peds Advisory Subcommittee Discussion (cont.)

_**February 2004**_:
- 	Use of  Imaging Drugs in conjunction with cardiac imaging procedures in the pediatric population
- 	Suicidality in clinical trials for anti-depressant drugs in pediatric patients: the issues and the approach.

## Prior Peds Advisory Committee Discussion (cont.)

_**October 2003**_**:** Clinical Risk Management of HPA Axis Suppression in Children with Atopic Dermatitis being treated with Topical Corticosteroids
- 	Tracking Cancer Risk among Children with Atopic Dermatitis who are treated with Topical Calcineurin Inhibitors

## Prior Peds Advisory Committee Discussion (cont.)

_**June 2004**_: Safety report update: SSRI’s and the Neonatal withdrawal syndrome and Congenital Eye Malformations
_**September 2004**_: First full Pediatric Advisory Committee -- Suicidality in clinical trials for anti-depressant drugs in pediatric patients

## Prior Peds Advisory Committee Discussion (cont.)

- _February 2005_:
- 	Discussion of approach to improving  BPCA safety reporting to the pediatric **advisory** committee
- _February 2005_:
- 	Potential cancer risk in children from use of topical calcineurin inhibitors

## 1-Year Post-ExclusivityReporting of Adverse Events June & October, 2003;  February 2004 

- Tamoxifen
- Quinapril
- Paroxetine
- Nefazodone
- Citalopram
- Pravastatin
- Vinorelbine

- Sertraline
- Oxybutynin
- Atorvastatin
- Simvastatin
- Busulfan
- Cetirizine
- Losartan

## 1-Year Post-ExclusivityReporting of Adverse Events June 2004

- Topotecan
- Temozolomide
- Venlafaxine
- Moxifloxacin

- Ciprofloxacin
- Fosinopril
- Fexofenadine
- Fentanyl

## 1-Year Post-Exclusivity ReportingSeptember 2004 and February 2005 

- Budesonide
- Desloratadine
- Fluticasone
- Ofloxacin
- Fludarabine
- Alendronate

- Benazepril
- Atovaquone/proguanil
- Esmolol
- Nelfinavir
- Orlistat
- Glyburide/metformin

##  1-Year Post-ExclusivityReporting of Adverse EventsJune 2005

- Ortho Tri-Cyclen- Norgestimate/ ethinyl estradiol
- Detrol and Detrol LA –Tolterodine tartrate
- Cipro –Ciprofloxacin
- Zemplar-Paricalcitol

- Zomig-Zolmitriptan
- Trusopt -Dorzolamide
- Arava – Leflunomide
- Concerta – OROS Methylphenidate

## Summary: 1999 to June 2005

-  Pediatric Advisory Panels for either Ethical or Scientific Discussions: 19
- Pediatric Advisory Panels to review adverse events for Exclusivity:  7
- Products Reviewed for Adverse Events under BPCA mandate            : 42
- New safety information identified for almost a dozen products used to treat children. Examples are: antidepressants, pain patches, products for treatment of asthma

## Evolving Process for Safety Reporting: BPCA 1-year Exclusivity

- Committee will continue to receive ALL of the written reviews:
-   ODS Adverse Event and Use Reviews
- Exclusivity Studies ( Medical and Pharmacology Reviews)
- Pediatric Division Slides
- Labeling

## Evolving Process: Cont’d

- FDA will provide an extensive assessment of products with possible new or increased safety signals. This may include additional information from both FDA and external experts.
- FDA will provide a brief oral summary for the Committee on products with no new or less concerning safety signals and will state why it has come to the conclusion this approach is adequate.

## Evolving Process: Cont’d

- Today and tomorrow the Committee will have the opportunity to review products which fit into the above categories and a few products which fell in between these categories.

## FDA’s Pediatric Advisory Experts

- Job very well done!
- But there is much more to come.
- Upcoming Issues: Obesity and therapeutic interventions
- More Ethical issues involving Trial Design
- Thank you