OVERVIEW OF FDAS PEDIATRIC ADVISORY COMMITTEE ACTIVITIES

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OVERVIEW OF FDAS PEDIATRIC ADVISORY COMMITTEE
ACTIVITIES

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

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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

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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)

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Pediatric Ethical IssuesSubpart D

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

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Prior Peds AdvisorySubcommittee 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

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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

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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.

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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

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Prior Peds Advisory Committee Discussion (cont.)

• June 2004 Safety report update SSRIs 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

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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

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1-Year Post-ExclusivityReporting of Adverse
Events June October, 2003 February 2004

• Sertraline
• Oxybutynin
• Atorvastatin
• Simvastatin
• Busulfan
• Cetirizine
• Losartan

• Tamoxifen
• Quinapril
• Paroxetine
• Nefazodone
• Citalopram
• Pravastatin
• Vinorelbine

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1-Year Post-ExclusivityReporting of Adverse
Events June 2004

• Ciprofloxacin
• Fosinopril
• Fexofenadine
• Fentanyl

• Topotecan
• Temozolomide
• Venlafaxine
• Moxifloxacin

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1-Year Post-Exclusivity ReportingSeptember 2004
and February 2005

• Budesonide
• Desloratadine
• Fluticasone
• Ofloxacin
• Fludarabine
• Alendronate

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

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1-Year Post-ExclusivityReporting of Adverse
EventsJune 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

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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

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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

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Evolving Process Contd

• 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.

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Evolving Process Contd

• 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.

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FDAs 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