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Overview of Pediatric Drug Development. Dianne Murphy, MD Director Office of Counterterrorism and Pediatric Drug Development Center for Drug Evaluation and Research February 2, 2004. Goals.

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overview of pediatric drug development

Overview of Pediatric Drug Development

Dianne Murphy, MD

Director

Office of Counterterrorism and Pediatric Drug Development

Center for Drug Evaluation and Research

February 2, 2004

goals
Goals
  • Provide condensed historical background to better understand how we arrived at the present place in pediatric drug development
  • Review FDA’s Pediatric Drug Development responsibilities
acronyms
Acronyms
  • FDAMA – Food and Drug Administration Modernization Act
  • BPCA – Best Pharmaceuticals for Children Act
  • PREA – Pediatric Research Equity Act
  • WR – Written Request (FDA issues)
  • PPSR – Proposed Pediatric Study Request (sponsor submits)
historical perspective
Historical Perspective
  • Tragedies in children lead to new laws
  • 1902 - Biologics Control Act
    • diphtheria antitoxin contaminated with live tetanus bacilli
  • 1938 - Food, Drug and Cosmetic Act
    • sulfanilamide
  • 1962 - Amendments
    • thalidomide
benchmarks pediatric drug development
BENCHMARKSPediatric Drug Development
  • 1977 – AAP statement concerning the need to conduct trials in children
  • 1979 – FDA requires trials in children parallel to adult process
  • 1994 – FDA requires sponsors to update label; introduces “extrapolations”
  • 1997 – Congress passes FDAMA/Exclusivity Provision – “Incentives” (voluntary)
  • 1998 – FDA publishes Pediatric Rule (mandatory)
benchmarks pediatric drug development cont
BENCHMARKSPediatric Drug Development (cont.)
  • 2002 –Congress passes Best Pharmaceuticals for Children Act (BPCA)
    • renewed Exclusivity
    • provides process for “off-patent” drug development
    • public posting of results
    • reporting of all AE’s for 1 year after Exclusivity granted
  • 2003 – Congress passes Pediatric Research Equity Act (PREA)
    • Requires the study of drugs and biologics for pediatric population except in defined situations
    • Creates Pediatric Advisory Committee
impact of legislation
Impact of Legislation
  • Proposals from Industry 336
  • FDA-issued Written Requests 283
  • Exclusivity Determinations 101
  • Exclusivity Granted 91
  • New Labels 63
1 year post exclusivity reporting of adverse events
Tamoxifen

Quinapril

Paroxetine

Nefazodone

Citalopram

Pravastatin

Vinorelbine

Sertraline

Oxybutynin

Atorvastatin

Simvastatin

Busulfan

Cetirizine

Losartan

1-Year Post-ExclusivityReporting of Adverse Events

Products

ethical issues
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)
prior peds advisory subcommittee discussion
Prior Peds Advisory Subcommittee Discussion

1999

  • November: Issues regarding a Pediatric Drug Development Program for the Treatment of Insomnia

2000

  • September: Pediatric Psychotropic Drug Use Issues

2001

  • April: Treatment of Chronic Hepatitis C in Children

2002

  • June: Reflux disease; GERD-Template
prior peds advisory subcommittee discussion cont
Prior Peds Advisory Subcommittee Discussion (cont.)

2003

  • March: Development of Antiretroviral Drugs in HIV-Infected and HIV-Exposed Neonates Younger than four weeks of age
  • June: Current Epidemiology and Therapeutic Interventions Relevant to Hyperbilirubinemia in the Term and Near-Term Newborn
  • October: 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

ongoing lessons learned
ONGOING LESSONS LEARNED

1- Pharmacokinetics are more variable than

anticipated

2-Adverse reactions that are pediatric specific are being defined

3-Trial designs are being modified as we learn from submitted studies

4-Ethical issues have to be reassessed from the pediatric perspective

general principles
General Principles*
  • Pediatric patients should be given medicines that have been properly evaluated for their use in the intended population
  • Product development programs should include pediatric studies when pediatric use is anticipated
  • Pediatric development should not delay adult studies nor adult availability
  • Shared responsibility among companies, regulatory authorities, health professionals, and society as a whole

* from ICH E-11

to find out more
To Find out More

Internet:

http://www.fda.gov/cder/pediatric

Peds Line:

(301) 594-7337