1 updates bpca - enacted january 4, 2002 pediatric rule - in effect pediatric rule statistics...
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UPDATES
• BPCA - Enacted January 4, 2002
• Pediatric Rule - In effect
• Pediatric Rule Statistics
• Exclusivity Statistics
• Reorganization
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
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Pediatric Rule Update4/1/99 - 3/31/02
Applications 404
Waivers (partial/complete) 195
Complete Waivers130
Deferrals 172
Completed Studies 94
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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
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Pediatric Rule Update4/1/99 - 3/31/02
Examples of Indications/Diseases Waived
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
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Pediatric Rule Update4/1/99 - 3/31/02
Examples of Indications/Diseases Waived
Sleep disorder Prostate cancer Post-menopausal breast
cancer Colorectal Polyps Advanced ovarian
cancer
Fertility BPH Abortifacient Vaginal candidiasis (0-
12yr) COPD
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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
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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
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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
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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
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Labeled Products
• Ibuprofen - Motrin• Ibuprofen - Advil• Midazolam*• Abacavir• Ranitidine• Insulin glargine• Pemirolast• Azelastine• Lovastatin
• Oxaprozin• Lamivudine - HBV• Pimecrolimus*• Brimonidine• Buspirone*• Ibuprofen/pseudoephe-
drine
• Sotalol• Ketorolac
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Labeled Products
• Ammonium lactate• Etodolac*• Fluvoxamine*• Sevoflurane*• Atovaquone/proguanil• Betamethasone*• Ribavirin/Intron A*• Gabapentin*• Loratadine
• Metformin• Enalapril• Propofol*• Cromolyn• Calcitriol• Didanosine• Stavudine• Isotretinoin• Famotidine
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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.
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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 than 12 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
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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)
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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
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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
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N ew O rgan iz atio nO cto b er 2002
*Ju n e 2 0 0 2
O D E I O D E II O D E III O D E IV O D E V O ffice of Ped iatric Dru gDevelop m en t &
Prog ram In itiatives*
O ffice o f N ew D ru g s
C en te r fo r D ru g s*
F D A
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