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UPDATES

UPDATES. BPCA - Enacted January 4, 2002 Pediatric Rule - In effect Pediatric Rule Statistics Exclusivity Statistics Reorganization. Pediatric Initiatives. Pediatric Rule (1998)

jennifer-silva
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UPDATES

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  1. UPDATES • BPCA - Enacted January 4, 2002 • Pediatric Rule - In effect • Pediatric Rule Statistics • Exclusivity Statistics • Reorganization

  2. Pediatric Initiatives • Pediatric Rule (1998) - FDA’s legal authority to require studies in pediatric patients has been challenged by the Association of American Physicians and surgeons, the Competitive Enterprise Institute and Consumer Alert - HHS Secretary announced that FDA will continue to defend the Pediatric Rule in court and not pursue a stay of litigation (April 19, 2002). - THE PEDIATRIC RULE REMAINS IN EFFECT

  3. Pediatric Rule Update4/1/99 - 3/31/02 Applications 404 Waivers (partial/complete) 195 Complete Waivers 130 Deferrals 172 Completed Studies 94

  4. Pediatric Rule Update4/1/99 - 3/31/02 • Reason for Deferrals • Do not want to hold up the adult approval • Desire for additional data before proceeding to younger age groups • Reason for Waivers • Safety issue • Small #'s of patients • OTC indication- not self-diagnosable • Adult indication- not applicable to pediatrics • Fixed combinations • Not a meaningful therapeutic benefit/substantial number • Literature information supports pediatric labeling

  5. Osteoporosis Reduction of facial hair in women Acne vulgaris (0-11yr) HIV infection (fixed-dose combination) Facial wrinkles Actinic keratosis MI/stroke/angina Parkinson's disease Dementia of Alzheimers Pediatric Rule Update4/1/99 - 3/31/02Examples of Indications/Diseases Waived

  6. Sleep disorder Prostate cancer Post-menopausal breast cancer Colorectal Polyps Advanced ovarian cancer Fertility BPH Abortifacient Vaginal candidiasis (0-12yr) COPD Pediatric Rule Update4/1/99 - 3/31/02Examples of Indications/Diseases Waived

  7. Applications Subject to the Rule and Exclusivity Granted Abacavir Didanosine Ammonium lactate Enalapril Atorvastatin Etodolac Azelastine Famotidine Brimonidine Fluoxetine Buspirone Gabapentin Calcitriol Ibuprofen Cetirizine Ibuprofen/Pseud Cromolyn Insulin glargine

  8. Applications Subject to the Rule and Exclusivity Granted Lamivudine Propofol Loratadine Remifentanil Lovastatin Ribavirin/Intron A Metformin Sertraline Mometsone Sevoflurane Montelukast Simvastatin Nevirapine Sotalol Pemirolast Stavudine Pimecrolimus Tramadol

  9. Pediatric Exclusivity Statsas of 6/1/02 Proposed Pediatric Study Requests 310 Written Requests 246 Exclusivity Determinations 66 Exclusivity Granted 58 Exclusivity Denied 8 Drugs Labeled 36

  10. Pediatric Exclusivity Statsas of 6/1/02 Types of Studies Efficacy 201 34 PK & Safety 175 30 PK/PD 56 10 Safety 97 17 Other 51 9 • 580 studies requested • 33,449 projected total # of patients

  11. Ibuprofen - Motrin Ibuprofen - Advil Midazolam* Abacavir Ranitidine Insulin glargine Pemirolast Azelastine Lovastatin Oxaprozin Lamivudine - HBV Pimecrolimus* Brimonidine Buspirone* Ibuprofen/pseudoephe-drine Sotalol Ketorolac Labeled Products

  12. Ammonium lactate Etodolac* Fluvoxamine* Sevoflurane* Atovaquone/proguanil Betamethasone* Ribavirin/Intron A* Gabapentin* Loratadine Metformin Enalapril Propofol* Cromolyn Calcitriol Didanosine Stavudine Isotretinoin Famotidine Labeled Products

  13. Labeled Products with Significant Changes for Dosing or Risk Midazolam (Versed): Sedation/anxiolysis/amnesia- higher risk of serious life-threatening situations in children with congenital heart disease and pulmonary hypertension and identified need to begin therapy at lower end of dosing range in this subpopulation to prevent respiratory compromise Etodolac (Lodine): JRA sign/symptom relief (6yr-16yr) -higher dose (per kg basis) needed in younger children approximately 2 times the lower dose recommended in adults for effective treatment Fluvoxamine (Luvox): Rx of OCD - higher doses in adolescents than previously recommended; girls ages 8-11 years may require lower doses.

  14. Labeled Products with Significant Changes for Dosing or Risk Gabapentin (Neurontin): - adjunctive Rx in partial seizures - higher doses required in children less than 5 years of age in order to control seizures; new adverse events (e.g. hostility and aggression) identified in children less than12 years Propofol (Diprivan): -induction and/or maintenance of anesthesia - increased mortality when used for pediatric ICU sedation over standard sedative agents (9% vs. 4%); serious bradycardia when propofol is concomitantly administered with fentanyl Sevoflurane (Ultane): induction and maintenance of general anesthesia - rare cases of seizures reported in children without a previous seizure history

  15. Labeled Products with Significant Changes for Dosing or Risk Ribavirin/Intron A (Rebetron): increased incidence of suicidal ideation or attempts among pediatric patients as compared with adults (2.4% vs. 1%); decreased rate of linear growth and weight gain during therapy, with general reversal in the post treatment period Pimecrolimus (Elidel) - indicated for short-term and intermittent long-term therapy in mild-moderate atopic dermatitis in non-immunocompromised patients >2years of age; (NOT RECOMMENDED in patients <2 years of age for safety concerns including infections, pyrexia, and diarrhea)

  16. Labeled Products with Significant Changes for Dosing or Risk Betamethasone (Diprolene AF): Corticosteroid responsive dermatoses; NOT RECOMMENDED in pediatric patients <12 years of age; HPA axis suppression; local adverse reactions, including signs of skin atrophy in 10% of patients 3 mo-12 yrs of age Betamethasone (Diprosone Cream, Ointment, Lotion): NOT RECOMMENDED in patients <12 years of age; HPA axis suppression; local adverse reactions included signs of skin atrophy (telangectasia, bruising, shininess) in cream & ointment but not lotion Betamethasone (Lotrisone): NOT RECOMMENDED in patients <17 years of age; HPA axis suppression

  17. Labeled Product with Safety and Effectiveness Issue Buspirone (Buspar) • - Safety and effectiveness were NOT established in patients 6-17 years of age for treatment of • General Anxiety Disorder at doses recommended • for adults; • - AUC and Cmax of buspirone and active metabolite were equal to or higher in children and adolescents as compared with adult PK parameters

  18. Additional Information Internet: http://www.fda.gov/cder/pediatric Peds Line: (301) 594-7337

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