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Pediatric Advisory Committee June 29, 2005 Dianne Murphy, MD Director, Office of Pediatric Therapeutics OC, FDA. OVERVIEW OF FDA’S PEDIATRIC ADVISORY COMMITTEE ACTIVITIES. Review of Pediatric Expert Panel Activities: An Evolving Process.

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Overview of fda s pediatric advisory committee activities

Pediatric Advisory Committee

June 29, 2005

Dianne Murphy, MD

Director, Office of Pediatric Therapeutics

OC, FDA

OVERVIEW OF FDA’S PEDIATRIC ADVISORY COMMITTEE ACTIVITIES


Review of pediatric expert panel activities an evolving process
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
Ethical Issues Process

  • 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
Pediatric Ethical Issues ProcessSubpart 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
Prior Peds Advisory ProcessSubcommittee 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
Prior Peds Advisory Subcommittee Discussion Process(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 cont1
Prior Peds Advisory Subcommittee Discussion Process(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
Prior Peds Advisory Committee Discussion Process(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 cont1
Prior Peds Advisory Committee Discussion Process(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 cont2
Prior Peds Advisory Committee Discussion Process(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 Process

Quinapril

Paroxetine

Nefazodone

Citalopram

Pravastatin

Vinorelbine

Sertraline

Oxybutynin

Atorvastatin

Simvastatin

Busulfan

Cetirizine

Losartan

1-Year Post-ExclusivityReporting of Adverse EventsJune & October, 2003; February 2004


1 year post exclusivity reporting of adverse events june 2004

Topotecan Process

Temozolomide

Venlafaxine

Moxifloxacin

Ciprofloxacin

Fosinopril

Fexofenadine

Fentanyl

1-Year Post-ExclusivityReporting of Adverse EventsJune 2004


1 year post exclusivity reporting september 2004 and february 2005

Budesonide Process

Desloratadine

Fluticasone

Ofloxacin

Fludarabine

Alendronate

Benazepril

Atovaquone/proguanil

Esmolol

Nelfinavir

Orlistat

Glyburide/metformin

1-Year Post-Exclusivity ReportingSeptember 2004 and February 2005


1 year post exclusivity reporting of adverse events june 2005

Ortho Tri-Cyclen- Norgestimate/ ethinyl estradiol Process

Detrol and Detrol LA –Tolterodine tartrate

Cipro –Ciprofloxacin

Zemplar-Paricalcitol

Zomig-Zolmitriptan

Trusopt -Dorzolamide

Arava – Leflunomide

Concerta – OROS Methylphenidate

1-Year Post-ExclusivityReporting of Adverse EventsJune 2005


Summary 1999 to june 2005
Summary: 1999 to June 2005 Process

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
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
Evolving Process: Cont’d Exclusivity

  • 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 d1
Evolving Process: Cont’d Exclusivity

  • 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
FDA’s Pediatric Advisory Experts Exclusivity

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