List of Drugs for Which Pediatric Studies Are Needed, 23931-23936 [E6-6122]
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Federal Register / Vol. 71, No. 79 / Tuesday, April 25, 2006 / Notices
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(Catalogue of Federal Domestic Assistance
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PO 00000
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93.846–93.878, 83.892, 93.893, National
Institutes of Health, HHS)
Dated: April 13, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–3880 Filed 4–24–06; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP);
Office of Chemical Nomination and
Selection; Announcement of and
Request for Public Comment on
Toxicological Study Nominations to
the NTP; Clarification
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health.
ACTION: Clarification.
AGENCY:
SUMMARY: The NTP is issuing a
clarification of a Federal Register notice
published on April 11, 2006 (Volume
71, Number 69, pages 18341–18344),
because a table summarizing the
toxicological study nominations
contains several misaligned columns
and rows. A correct version of the table
is available on the NTP Web site at
https://ntp.niehs.nih.gov/go/21134 or by
contacting Dr. Scott Masten (see
ADDRESSES below).
ADDRESSES: Correspondence should be
addressed to Dr. Scott A. Masten,
Director, Office of Chemical Nomination
and Selection, NIEHS/NTP, 111 T.W.
Alexander Drive, P.O. Box 12233,
Research Triangle Park, North Carolina
27709; telephone: 919–541–5710; FAX:
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Dated: April 12, 2006.
David Schwartz,
Director, National Institute of Environmental
Health Sciences and National Toxicology
Program.
[FR Doc. E6–6121 Filed 4–24–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
List of Drugs for Which Pediatric
Studies Are Needed
ACTION:
Notice.
SUMMARY: The National Institutes of
Health (NIH) is providing notice of the
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Federal Register / Vol. 71, No. 79 / Tuesday, April 25, 2006 / Notices
‘‘List of Drugs for Which Pediatric
Studies Are Needed.’’ The NIH
developed the list in consultation with
the Food and Drug Administration
(FDA) and pediatric experts, as
mandated by the Best Pharmaceuticals
for Children Act. This list prioritizes
certain drugs most in need of study for
use by children to ensure their safety
and efficacy. The NIH will update the
list at least annually until the Act
expires on October 1, 2007.
DATES: The list is effective upon
publication.
Dr.
Perdita Taylor-Zapata, National Institute
of Child Health and Human
Development (NICHD), 6100 Executive
Boulevard, Suite 4A–01, Bethesda, MD
20892–7510, e-mail
taylorpe@mail.nih.gov or
BestPharmaceuticals@mail.nih.gov,
telephone 301–496–9584 (not a toll-free
number).
FOR FURTHER INFORMATION CONTACT:
The NIH
is providing notice of the ‘‘List of Drugs
for Which Pediatric Studies Are
Needed,’’ as authorized under Section 3,
Pub. L. 107–109 (42 U.S.C. 409I). On
January 4, 2002, President Bush signed
into law the Best Pharmaceuticals for
Children Act (BPCA). The BPCA
mandates that not later than one year
after the date of enactment, the NIH in
consultation with the FDA and experts
in pediatric research shall develop,
prioritize, and publish an annual list of
certain approved drugs for which
pediatric studies are needed. For
inclusion on the list, an approved drug
must meet the following criteria: (1)
There is an approved application under
section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)); (2)
there is a submitted application that
could be approved under the criteria of
section 505(j) of the Federal Food, Drug,
and Cosmetic Act; (3) there is no patent
protection or market exclusivity
SUPPLEMENTARY INFORMATION:
protection under the Federal Food,
Drug, and Cosmetic Act; or (4) there is
a referral for inclusion on the list under
section 505A(d)(4)(c); and additional
studies are needed to assess the safety
and effectiveness of the use of the drug
in the pediatric population. The BPCA
further stipulates that in developing and
prioritizing the list, the NIH shall
consider, for each drug on the list: (1)
The availability of information
concerning the safe and effective use of
the drug in the pediatric population; (2)
whether additional information is
needed; (3) whether new pediatric
studies concerning the drug may
produce health benefits in the pediatric
population; and (4) whether
reformulation of the drug is necessary.
For this year, we are providing an
update on all of the drugs listed since
the enactment of BPCA and a brief
status report on each of the drugs (see
Table 1).
TABLE 1.—CURRENT STATUS OF DRUGS THAT HAVE BEEN LISTED BY NIH (NICHD) FOR BPCA
Patent status
Written request/RFP
Clinical trial primary
site
Current status and/or
clinical trial design
2005
On-patent ....
FDA .............
N/A ............................
Infection ....................
2004
Off-patent ....
NICHD .........
N/A ............................
Ampicillin/sulbactam ..
Infection ....................
2003
Off-patent ....
FDA .............
N/A ............................
Azithromycin (IV) .......
Prevention of bronchopulmonary dysplasia (BPD) in
neonates colonized
with Ureaplasma
urealyticum.
Prevention treatment
of Chlamydia conjunctivitis and
pneumonia.
2003
Off-patent ....
NICHD .........
N/A ............................
Recommended for systematic review for potential
re-labeling based on published literature.
Awaiting systematic literature review for the development of RFP.
Inactive. Being reconsidered due to feasibility
issues.
PK, safety, efficacy, tolerability studies proposed.
Currently reviewing scientific issues.
2003
Off-patent ....
NICHD .........
N/A ............................
Baclofen* ...................
Oral treatment of
spasticity from cerebral palsy.
2003
On-patent ....
FNIH,
NICHD.
Negotiations ongoing
Bumetanide ................
Diuresis .....................
2003
Off-patent ....
FDA .............
N/A ............................
Bupropion* .................
Treatment of Depression.
2004
On-patent ....
FNIH,
NICHD.
N/A ............................
Bupropion* .................
Treatment for smoking cessation.
2004
On-patent ....
FNIH,
NICHD.
N/A ............................
Drug
Indication
Acyclovir* ...................
Herpetic infections ....
Ampicillin ....................
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Azithromycin (PO) .....
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Inactive for this indication.
Initial Studies proposed
difficult to conduct due to
feasibility issues. RFP released but no responses
received. Indication being
reconsidered.
Plan is for Pharmacokinetics, safety and efficacy studies. FNIH considering funding.
Has been recommended for
consultation with scientific community concerning diagnosis and
treatment of pediatric hypertension, and the role
of diuretics in treatment.
Recommended for systematic review and consultation with scientific community. Written Request
referred to FNIH.
Written Request referred to
FNIH.
23933
Federal Register / Vol. 71, No. 79 / Tuesday, April 25, 2006 / Notices
TABLE 1.—CURRENT STATUS OF DRUGS THAT HAVE BEEN LISTED BY NIH (NICHD) FOR BPCA—Continued
Patent status
Written request/RFP
Clinical trial primary
site
Current status and/or
clinical trial design
2005
Off-patent ....
FDA .............
N/A ............................
Attention deficit disorder.
2005
Off-patent ....
FDA .............
N/A ............................
Cyclosporine ..............
Cardiac transplant rejection.
2005
Off-patent ....
FDA .............
N/A ............................
Dactinomycin .............
Cancer ......................
2004
Off-patent ....
NICHD .........
NICHD Partnership
with NCI/Children’s
Oncology Group.
Daunomycin ...............
Dexrazoxane* ............
Cancer ......................
Prophylaxis from
cardiotoxicity of
doxorubicin.
Hypoglycemia ...........
2006
2005
Off-patent ....
On-patent ....
FDA .............
FNIH,
NICHD.
N/A ............................
N/A ............................
Data gathering in process.
Indication being reconsidered due to feasibility
issues.
Recommended for systematic review and consultation with scientific community. Reconsidered for
listing for 2006 under
condition-based approach.
Recommended for systematic review and consultation with scientific community to discuss feasibility and study design in
cardiac transplant patients.
Clinical studies being conducted by Children’s Oncology Group in conjunction with NCI to better
define safety, efficacy,
PK.
WR in process.
WR referred to FNIH.
2003
Off-patent ....
FDA .............
N/A ............................
Hypotension, low cardiac output in neonates.
Hypotension, low cardiac output in neonates.
Migraine headaches
in adolescents.
Tuberculosis .............
Ventricular arrhythmia.
2003
Off-patent ....
FDA .............
N/A ............................
2003
Off-patent ....
FDA .............
N/A ............................
2005
On-patent ....
N/A ............................
2005
2005
Off-patent ....
Off-patent ....
FNIH,
NICHD.
FDA .............
FDA .............
Furosemide ................
Diuresis .....................
2003
Off-patent ....
FDA .............
N/A ............................
Griseofulvin ................
Tinea capitis .............
2005
Off-patent ....
NICHD .........
N/A ............................
Heparin ......................
Anticoagulation .........
2003
Off-patent ....
FDA .............
...................................
Hydrochlorothiazide ...
Hypertension ............
2005
Off-patent ....
FDA .............
N/A ............................
Hydrocortisone valerate ointment and
cream*.
Hydroxychloroquine ...
Dermatitis .................
2005
On-patent ....
FDA .............
N/A ............................
Data gathering in process.
Recommended for systematic review and consultation with scientific community to determine feasibility and study design.
Recommend consultation
with scientific community
concerning diagnosis and
treatment of pediatric hypertension, and the role
of diuretics in treatment.
Development of RFP in
progress.
Already labeled for patients
≥ 1 kg.
Recommend consultation
with scientific community
concerning diagnosis and
treatment of pediatric hypertension, and the role
of diuretics in treatment.
Inactive.
Connective tissue
disorders.
Sickle Cell Disease ..
2005
Off-patent ....
FDA .............
N/A ............................
WR in process.
2006
On-patent ....
FNIH,
NICHD.
NICHD Partnership
with NHLBI.
PK, efficacy and safety
studies under way. FNIH
considering funding.
Drug
Indication
Clonidine ....................
Autism .......................
Clonidine ....................
Diazoxide ...................
Dobutamine ...............
Dopamine ..................
Eletriptan* ..................
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Ethambutol .................
Flecainide ..................
Hydroxyurea* .............
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N/A ............................
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Inactive. Being considered
for labeling based on literature review.
Inactive due to issues with
feasibility and clinical trial
design.
Inactive due to issues with
feasibility and clinical trial
design.
WR referred to FNIH.
23934
Federal Register / Vol. 71, No. 79 / Tuesday, April 25, 2006 / Notices
TABLE 1.—CURRENT STATUS OF DRUGS THAT HAVE BEEN LISTED BY NIH (NICHD) FOR BPCA—Continued
Patent status
Written request/RFP
Clinical trial primary
site
Current status and/or
clinical trial design
2003
Off-patent ....
FDA .............
N/A ............................
Scabies .....................
2005
Off-patent ....
FDA .............
N/A ............................
Ketamine ....................
Sedation ...................
2004
Off-patent ....
FDA .............
NICHD Partnership
with NCTR, FDA.
Lindane ......................
2003
Off-patent ....
FDA .............
N/A ............................
Lithium .......................
Second line treatment of scabies.
Treatment of mania
in bipolar disorder.
2003
Off-patent ....
NICHD .........
Case Western Reserve University.
Lorazepam .................
Treatment of Status
Epilepticus.
2003
Off-patent ....
NICHD .........
Children’s National
Medical Center.
Lorazepam .................
Sedation in the intensive care unit for
children on respirators.
2003
Off-patent ....
NICHD .........
Case Western Reserve University.
Meropenem ................
Methadone .................
2003
2005
Off-patent ....
Off-patent ....
NICHD .........
FDA .............
N/A ............................
N/A ............................
2006
2003
Off-patent ....
On-patent ....
FDA .............
NICHD .........
N/A ............................
N/A ............................
Metolazone ................
Infection ....................
Neonates with opioid
withdrawal.
Cancer ......................
Gastro-esophageal
reflux.
Diuresis .....................
Awaiting results of
Ketamine preclinical
study and results to be
extrapolated.
Formulation issues may
preclude study.
Preclinical toxicology studies under way. Clinical
studies will not be designed until the preclinical studies are completed.
WR accepted by NDA holder.
PK, safety, efficacy, and
tolerability studies to be
performed.
PK, efficacy, and safety.
Participants are currently
being enrolled in PK
study. Feasibility issues
with efficacy trial.
Pharmacokinetics, safety,
efficacy by randomized
double-blind active comparator study. Participants are currently being
enrolled.
Currently in negotiations.
Data gathering in process.
2004
Off-patent ....
FDA .............
N/A ............................
Morphine* ..................
Analgesia ..................
2004
On-patent ....
FNIH,
NICHD.
Children’s National
Medical Center.
Piperacillin/
tazobactam.
Infection ....................
2003
Off-patent ....
FDA .............
N/A ............................
Pralidoxime ................
Organophosphate
Poisoning.
Nausea and vomiting
2006
Off-patent ....
Pending .......
N/A ............................
2003
Off-patent ....
FDA .............
N/A ............................
Methicillin-resistant
Staphylococcus
aureus endocarditis.
Central nervous system shunt infection.
Hyperphosphatemia
in chronic renal
failure.
2003
Off-patent ....
NICHD .........
N/A ............................
2003
Off-patent ....
NICHD .........
N/A ............................
2005
On-patent ....
FNIH,
NICHD.
N/A ............................
Drug
Indication
Isofluorane .................
Maintenance of general anesthesia.
Ivermectin ..................
Methotrexate ..............
Metoclopramide* ........
Promethazine .............
Rifampin .....................
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Rifampin .....................
Sevelamer* ................
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WR in process.
Inactive due to change in
patent status after listing.
Recommend consultation
with scientific community
concerning diagnosis and
treatment of pediatric hypertension and the role of
diuretics in treatment.
Basic science studies are
needed to determine the
developmental expression and function of
opioid receptors. FNIH
considering funding.
Grant awarded by NICHD
in 2005 for study in neonates.
Inactive. Being reconsidered due to feasibility
issues.
Recommended for systemic
literature review.
Inactive. Under consideration for removal from list
due to current black
boxed warning.
Inactive. Frequency of condition being reviewed.
Inactive. Frequency of condition being reviewed.
Written Request referred to
FNIH.
Federal Register / Vol. 71, No. 79 / Tuesday, April 25, 2006 / Notices
23935
TABLE 1.—CURRENT STATUS OF DRUGS THAT HAVE BEEN LISTED BY NIH (NICHD) FOR BPCA—Continued
Patent status
Written request/RFP
2003
Off-patent ....
NICHD .........
Duke and Stanford
Universities.
Diuresis .....................
2003
Off-patent ....
FDA .............
N/A ............................
Vincristine ..................
Cancer ......................
2004
Off-patent ....
NICHD .........
NICHD Partnership
with NCI/Children’s
Oncology Group.
Zonisamide* ...............
Partial Seizures ........
2005
On-patent ....
FNIH,
NICHD.
N/A ............................
Drug
Indication
Listing
Sodium nitroprusside
Control of blood pressure.
Spironolactone ...........
Clinical trial primary
site
Current status and/or
clinical trial design
Pharmacokinetics, safety,
efficacy by randomized
double-blind parallel
group study design. Participants are currently
being enrolled.
Recommend consultation
with scientific community
concerning diagnosis and
treatment of pediatric hypertension and the role of
diuretics in treatment.
Clinical studies being conducted by Children’s Oncology Group with National Cancer Institute to
better define safety, efficacy, and PK.
Written Request referred to
FNIH.
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Key: Drug is the generic name. Indication summarizes the indication or condition for which the drug is to be tested. Listing notes the year in
which the drug was added to the list for testing. Patent Status is the on- or off-patent status of the drug. WR indicates a Written Request has
been issued by the FDA and denotes where the request for and the processing of information currently resides (FDA, Foundation for NIH (FNIH)
or NIH). Request for Proposals (RFP) indicates the RFP was published by NICHD and its current status. Clinical Trial Primary Site identifies the
institution that has received the contract and has designed and implemented the preclinical or clinical protocol. Clinical Trial Design indicates in
general terms the format of the proposed or actual preclinical or clinical trials and the phases of drug development being conducted. N/A refers
to a process that is not applicable to a particular drug at this time. NHLBI is the National Heart, Lung, and Blood Institute; NCI is the National
Cancer Institute; NIEHS is the National Institute of Environmental Health Sciences; NIMH is the National Institute of Mental Health; and NCTR is
the National Center for Toxicological Research, part of the FDA.
* Indicates that a drug is currently on-patent and will be studied under a different funding mechanism than the off-patent process as described
in the BPCA Legislation of 2002. For an on-patent drug, if the manufacturer has denied or failed to respond to the WR issued by the FDA in 120
days, the FDA refers the drug to the FNIH and requests that it be considered for FNIH support of pediatric studies. These drugs are also discussed at the annual scientific listing meetings.
As previously stated, NICHD and the
FDA have reviewed the progress of the
drugs currently listed under BPCA in
addition to a review of the entire listing
process since its inception. There are
drugs listed that are currently
considered inactive or are being
reconsidered due to multiple factors.
Many of the factors for reconsideration
are based on feasibility issues related to
clinical trial design and the overall
conduct of a study with that particular
drug and/or indication—such as
frequency of condition, statistical
power, and safety. A drug may also be
considered inactive if there has been a
change in patent status since its original
listing. These drugs will continue to be
reevaluated throughout the year and an
update will be provided no later than
January 2007.
Upon review of the BPCA listing
process and based on our goal of
improving pediatric therapeutics, NIH
and FDA have decided to change our
listing system to a therapeutic classbased approach. We believe that this
approach will allow us to compare
drugs within a therapeutic class (onand off-patent) and give a broader
description for the availability and use
of these drugs in children. This will also
allow us to obtain focused expertise in
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therapeutic areas that will subsequently
give us more insight into feasibility and
study designs. We drafted and
categorized a preliminary list of drugs
for the 2006 Priority List based on the
newly developed condition-based
approach in an effort to identify areas in
pediatrics that may contain gaps in
knowledge in the area of therapeutic
options. In developing this list, the NIH
consulted with the FDA and experts in
pediatric research and practice. The
following are the conditions and the
drugs discussed in our November 8–9,
2005, scientific meeting with experts in
pediatric research and determined to
need more scientific evidence before
studies can be conducted in children:
Attention Deficit and Hyperactivity
Disorder (ADHD), Hypertension,
Parasitic Diseases, Influenza, Cancer,
Poisonings, and Sickle Cell Anemia.
The drugs thought to be effective for
treatment in each of these conditions
were then prioritized based on the
potential for providing a health benefit
in the general pediatric population.
ADHD was identified as a therapeutic
area of interest because of its
tremendous impact on the use of
psychotropic medications in children—
remaining the most commonly
diagnosed behavioral disorder of
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
childhood. Clonidine and Guanfacine
were discussed as off-patent drugs that
require further information in children.
We determined that we need further
discussion with the primary care and
mental health communities to
determine if studies of these agents are
warranted for the treatment of ADHD or
if the primary use of these agents is as
adjunctive agents because of their
sedative properties. In 2005, NICHD
learned of a published report in Cancer
Letters discussing possible cytogenetic
effects in children treated with
Methylphenidate (Cytogenetic effects in
children treated with methylphenidate,
El-Zein, R. et al., Cancer Letters xx
(2005), 1–8.). NICHD developed a
partnership with the National Institute
of Environmental Health Sciences, the
National Institute of Mental Health, the
National Center for Toxicology
Research, and the FDA to further
evaluate this finding.
Hypertension was identified as a
therapeutic area of interest due to the
recent ‘‘Fourth Report on the Diagnosis,
Evaluation, and Treatment of High
Blood Pressure in Children and
Adolescents,’’ published in Pediatrics in
2004, which identified a need to
determine a treatment strategy for high
blood pressure in children, especially
E:\FR\FM\25APN1.SGM
25APN1
wwhite on PROD1PC65 with NOTICES
23936
Federal Register / Vol. 71, No. 79 / Tuesday, April 25, 2006 / Notices
with the increasing epidemic of obesity
and obesity-related diseases in this
country. The therapeutic drugs class of
Diuretics (Bumetanide, Furosemide,
Hydrochlorothiazide, Spironolactone)
were discussed as off-patent drugs that
require further information in children.
It was determined that we need further
discussion with the pediatric experts
involved in the development of the
‘‘Fourth Report’’ to determine if, and
how, this particular class of drugs is
used in primary pediatric hypertension
and how a clinical study might be
structured to address the complex issues
that have recently arisen, such as
obesity-related hypertension, in the
diagnosis and treatment of this disease.
Parasitic Diseases was identified as a
therapeutic area of interest due to the
tremendous impact on morbidity and
mortality that these diseases have in
children worldwide. Albendazole and
Mebendazole were discussed as offpatent drugs that require further
information in children. It was
determined that we need to consult with
domestic (Centers for Disease Control
and Prevention) and foreign sources
(World Health Organization) and other
areas where these agents are
predominantly monitored and used to
obtain safety information. It was also
determined that a liquid formulation of
Albendazole would be advantageous for
children of developing countries, in
whom these diseases occur more often.
Influenza was identified as a
therapeutic area of interest because of
the emerging threat of pandemic flu and
the lack of dosing and efficacy data in
our most vulnerable pediatric
population—children less than 1 year of
age. Amantidine and Rimantidine were
discussed as off-patent drugs that
require further information in children.
It was determined that we need more
information on the effectiveness of these
drugs to provide additional insight into
the use of these agents in the population
of children less than 1 year of age.
Cancer has been identified as an
ongoing therapeutic area of interest
because of the extensive morbidity and
mortality that this disease continues to
exhibit in pediatric patients of all ages.
Poisoning was identified as a
therapeutic area of interest due to the
fact that injuries and poisonings remain
as one of the top 5 conditions that lead
to the highest morbidity and mortality
in young children and adolescents.
Sickle Cell Anemia was identified as
a therapeutic area of interest because of
the extensive morbidity caused by, and
paucity of treatment options for, this
disease.
The following are the conditions and
drugs discussed in our November 8–9,
VerDate Aug<31>2005
16:59 Apr 24, 2006
Jkt 208001
2005, scientific meeting with experts in
pediatric research. We will add these
conditions and drugs to the 2006
priority list for which pediatric studies
are most urgently needed, along with
their indications for use:
Treatment of Pediatric Cancers:
Methotrexate and Daunomycin
There is an urgent need for
information regarding the
pharmacokinetics and toxicity of
daunomycin in obese children. There is
an urgent need to evaluate the
neurotoxicity and long-term cognitive
outcomes of children receiving
methotrexate.
Treatment of Sickle Cell Anemia:
Hydroxyurea
There is an urgent need for further
pharmacokinetic and long-term safety
data in the use of this drug in children
with sickle cell anemia.
Treatment of Organophosphate
Poisoning: Pralidoxime
There is an urgent need for further
dosing information of the use of this
drug in children.
For the coming year, NICHD is
planning a series of discussions with
experts in the field of pediatric cancers
(NCI/COG), pediatric infectious
diseases, emergency care in pediatrics
(PECARN), pediatric-based research
networks (PBRN), pediatric
hypertension, and pediatric psychiatry,
in addition to our ongoing discussions
with the other NIH Institutes and
Centers. The goal of these discussions
will be to specifically identify current
gaps in scientific knowledge regarding
research and treatment of these various
pediatric conditions, with the ultimate
goal of determining future approved
drugs for which pediatric studies are
needed. NICHD will continue scientific
discussions and planning throughout
2006 and will provide an update in
January 2007.
Dated: April 11, 2006.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. E6–6122 Filed 4–24–06; 8:45 am]
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SECURITY
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[USCG–2006–23665]
Collection of Information Under
Review by Office of Management and
Budget (OMB): 1625–0009, 1625–0014,
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The ICRs are as follows: (1) 1625–0009,
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0014, Request for Designation and
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and Records for Tank, Passenger, Cargo
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DATES: Please submit comments on or
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ADDRESSES: To make sure that your
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]]>Agencies
[Federal Register Volume 71, Number 79 (Tuesday, April 25, 2006)]
[Notices]
[Pages 23931-23936]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6122]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
List of Drugs for Which Pediatric Studies Are Needed
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institutes of Health (NIH) is providing notice of
the
[[Page 23932]]
``List of Drugs for Which Pediatric Studies Are Needed.'' The NIH
developed the list in consultation with the Food and Drug
Administration (FDA) and pediatric experts, as mandated by the Best
Pharmaceuticals for Children Act. This list prioritizes certain drugs
most in need of study for use by children to ensure their safety and
efficacy. The NIH will update the list at least annually until the Act
expires on October 1, 2007.
DATES: The list is effective upon publication.
FOR FURTHER INFORMATION CONTACT: Dr. Perdita Taylor-Zapata, National
Institute of Child Health and Human Development (NICHD), 6100 Executive
Boulevard, Suite 4A-01, Bethesda, MD 20892-7510, e-mail
taylorpe@mail.nih.gov or BestPharmaceuticals@mail.nih.gov, telephone
301-496-9584 (not a toll-free number).
SUPPLEMENTARY INFORMATION: The NIH is providing notice of the ``List of
Drugs for Which Pediatric Studies Are Needed,'' as authorized under
Section 3, Pub. L. 107-109 (42 U.S.C. 409I). On January 4, 2002,
President Bush signed into law the Best Pharmaceuticals for Children
Act (BPCA). The BPCA mandates that not later than one year after the
date of enactment, the NIH in consultation with the FDA and experts in
pediatric research shall develop, prioritize, and publish an annual
list of certain approved drugs for which pediatric studies are needed.
For inclusion on the list, an approved drug must meet the following
criteria: (1) There is an approved application under section 505(j) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)); (2) there
is a submitted application that could be approved under the criteria of
section 505(j) of the Federal Food, Drug, and Cosmetic Act; (3) there
is no patent protection or market exclusivity protection under the
Federal Food, Drug, and Cosmetic Act; or (4) there is a referral for
inclusion on the list under section 505A(d)(4)(c); and additional
studies are needed to assess the safety and effectiveness of the use of
the drug in the pediatric population. The BPCA further stipulates that
in developing and prioritizing the list, the NIH shall consider, for
each drug on the list: (1) The availability of information concerning
the safe and effective use of the drug in the pediatric population; (2)
whether additional information is needed; (3) whether new pediatric
studies concerning the drug may produce health benefits in the
pediatric population; and (4) whether reformulation of the drug is
necessary. For this year, we are providing an update on all of the
drugs listed since the enactment of BPCA and a brief status report on
each of the drugs (see Table 1).
Table 1.--Current Status of Drugs That Have Been Listed by NIH (NICHD) for BPCA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written request/ Clinical trial Current status and/or clinical
Drug Indication Listing Patent status RFP primary site trial design
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acyclovir*.................... Herpetic 2005 On-patent........ FDA.............. N/A............. Recommended for systematic review
infections. for potential re-labeling based
on published literature.
Ampicillin.................... Infection........ 2004 Off-patent....... NICHD............ N/A............. Awaiting systematic literature
review for the development of
RFP.
Ampicillin/sulbactam.......... Infection........ 2003 Off-patent....... FDA.............. N/A............. Inactive. Being reconsidered due
to feasibility issues.
Azithromycin (IV)............. Prevention of 2003 Off-patent....... NICHD............ N/A............. PK, safety, efficacy, tolerability
bronchopulmonary studies proposed. Currently
dysplasia (BPD) reviewing scientific issues.
in neonates
colonized with
Ureaplasma
urealyticum.
Azithromycin (PO)............. Prevention 2003 Off-patent....... NICHD............ N/A............. Inactive for this indication.
treatment of Initial Studies proposed
Chlamydia difficult to conduct due to
conjunctivitis feasibility issues. RFP released
and pneumonia. but no responses received.
Indication being reconsidered.
Baclofen*..................... Oral treatment of 2003 On-patent........ FNIH, NICHD...... Negotiations Plan is for Pharmacokinetics,
spasticity from ongoing. safety and efficacy studies. FNIH
cerebral palsy. considering funding.
Bumetanide.................... Diuresis......... 2003 Off-patent....... FDA.............. N/A............. Has been recommended for
consultation with scientific
community concerning diagnosis
and treatment of pediatric
hypertension, and the role of
diuretics in treatment.
Bupropion*.................... Treatment of 2004 On-patent........ FNIH, NICHD...... N/A............. Recommended for systematic review
Depression. and consultation with scientific
community. Written Request
referred to FNIH.
Bupropion*.................... Treatment for 2004 On-patent........ FNIH, NICHD...... N/A............. Written Request referred to FNIH.
smoking
cessation.
[[Page 23933]]
Clonidine..................... Autism........... 2005 Off-patent....... FDA.............. N/A............. Data gathering in process.
Indication being reconsidered due
to feasibility issues.
Clonidine..................... Attention deficit 2005 Off-patent....... FDA.............. N/A............. Recommended for systematic review
disorder. and consultation with scientific
community. Reconsidered for
listing for 2006 under condition-
based approach.
Cyclosporine.................. Cardiac 2005 Off-patent....... FDA.............. N/A............. Recommended for systematic review
transplant and consultation with scientific
rejection. community to discuss feasibility
and study design in cardiac
transplant patients.
Dactinomycin.................. Cancer........... 2004 Off-patent....... NICHD............ NICHD Clinical studies being conducted
Partnership by Children's Oncology Group in
with NCI/ conjunction with NCI to better
Children's define safety, efficacy, PK.
Oncology Group.
Daunomycin.................... Cancer........... 2006 Off-patent....... FDA.............. N/A............. WR in process.
Dexrazoxane*.................. Prophylaxis from 2005 On-patent........ FNIH, NICHD...... N/A............. WR referred to FNIH.
cardiotoxicity
of doxorubicin.
Diazoxide..................... Hypoglycemia..... 2003 Off-patent....... FDA.............. N/A............. Inactive. Being considered for
labeling based on literature
review.
Dobutamine.................... Hypotension, low 2003 Off-patent....... FDA.............. N/A............. Inactive due to issues with
cardiac output feasibility and clinical trial
in neonates. design.
Dopamine...................... Hypotension, low 2003 Off-patent....... FDA.............. N/A............. Inactive due to issues with
cardiac output feasibility and clinical trial
in neonates. design.
Eletriptan*................... Migraine 2005 On-patent........ FNIH, NICHD...... N/A............. WR referred to FNIH.
headaches in
adolescents.
Ethambutol.................... Tuberculosis..... 2005 Off-patent....... FDA.............. N/A............. Data gathering in process.
Flecainide.................... Ventricular 2005 Off-patent....... FDA.............. N/A............. Recommended for systematic review
arrhythmia. and consultation with scientific
community to determine
feasibility and study design.
Furosemide.................... Diuresis......... 2003 Off-patent....... FDA.............. N/A............. Recommend consultation with
scientific community concerning
diagnosis and treatment of
pediatric hypertension, and the
role of diuretics in treatment.
Griseofulvin.................. Tinea capitis.... 2005 Off-patent....... NICHD............ N/A............. Development of RFP in progress.
Heparin....................... Anticoagulation.. 2003 Off-patent....... FDA.............. ................ Already labeled for patients >= 1
kg.
Hydrochlorothiazide........... Hypertension..... 2005 Off-patent....... FDA.............. N/A............. Recommend consultation with
scientific community concerning
diagnosis and treatment of
pediatric hypertension, and the
role of diuretics in treatment.
Hydrocortisone valerate Dermatitis....... 2005 On-patent........ FDA.............. N/A............. Inactive.
ointment and cream*.
Hydroxychloroquine............ Connective tissue 2005 Off-patent....... FDA.............. N/A............. WR in process.
disorders.
Hydroxyurea*.................. Sickle Cell 2006 On-patent........ FNIH, NICHD...... NICHD PK, efficacy and safety studies
Disease. Partnership under way. FNIH considering
with NHLBI. funding.
[[Page 23934]]
Isofluorane................... Maintenance of 2003 Off-patent....... FDA.............. N/A............. Awaiting results of Ketamine
general preclinical study and results to
anesthesia. be extrapolated.
Ivermectin.................... Scabies.......... 2005 Off-patent....... FDA.............. N/A............. Formulation issues may preclude
study.
Ketamine...................... Sedation......... 2004 Off-patent....... FDA.............. NICHD Preclinical toxicology studies
Partnership under way. Clinical studies will
with NCTR, FDA. not be designed until the
preclinical studies are
completed.
Lindane....................... Second line 2003 Off-patent....... FDA.............. N/A............. WR accepted by NDA holder.
treatment of
scabies.
Lithium....................... Treatment of 2003 Off-patent....... NICHD............ Case Western PK, safety, efficacy, and
mania in bipolar Reserve tolerability studies to be
disorder. University. performed.
Lorazepam..................... Treatment of 2003 Off-patent....... NICHD............ Children's PK, efficacy, and safety.
Status National Participants are currently being
Epilepticus. Medical Center. enrolled in PK study. Feasibility
issues with efficacy trial.
Lorazepam..................... Sedation in the 2003 Off-patent....... NICHD............ Case Western Pharmacokinetics, safety, efficacy
intensive care Reserve by randomized double-blind active
unit for University. comparator study. Participants
children on are currently being enrolled.
respirators.
Meropenem..................... Infection........ 2003 Off-patent....... NICHD............ N/A............. Currently in negotiations.
Methadone..................... Neonates with 2005 Off-patent....... FDA.............. N/A............. Data gathering in process.
opioid
withdrawal.
Methotrexate.................. Cancer........... 2006 Off-patent....... FDA.............. N/A............. WR in process.
Metoclopramide*............... Gastro-esophageal 2003 On-patent........ NICHD............ N/A............. Inactive due to change in patent
reflux. status after listing.
Metolazone.................... Diuresis......... 2004 Off-patent....... FDA.............. N/A............. Recommend consultation with
scientific community concerning
diagnosis and treatment of
pediatric hypertension and the
role of diuretics in treatment.
Morphine*..................... Analgesia........ 2004 On-patent........ FNIH, NICHD...... Children's Basic science studies are needed
National to determine the developmental
Medical Center. expression and function of opioid
receptors. FNIH considering
funding. Grant awarded by NICHD
in 2005 for study in neonates.
Piperacillin/tazobactam....... Infection........ 2003 Off-patent....... FDA.............. N/A............. Inactive. Being reconsidered due
to feasibility issues.
Pralidoxime................... Organophosphate 2006 Off-patent....... Pending.......... N/A............. Recommended for systemic
Poisoning. literature review.
Promethazine.................. Nausea and 2003 Off-patent....... FDA.............. N/A............. Inactive. Under consideration for
vomiting. removal from list due to current
black boxed warning.
Rifampin...................... Methicillin- 2003 Off-patent....... NICHD............ N/A............. Inactive. Frequency of condition
resistant being reviewed.
Staphylococcus
aureus
endocarditis.
Rifampin...................... Central nervous 2003 Off-patent....... NICHD............ N/A............. Inactive. Frequency of condition
system shunt being reviewed.
infection.
Sevelamer*.................... Hyperphosphatemia 2005 On-patent........ FNIH, NICHD...... N/A............. Written Request referred to FNIH.
in chronic renal
failure.
[[Page 23935]]
Sodium nitroprusside.......... Control of blood 2003 Off-patent....... NICHD............ Duke and Pharmacokinetics, safety, efficacy
pressure. Stanford by randomized double-blind
Universities. parallel group study design.
Participants are currently being
enrolled.
Spironolactone................ Diuresis......... 2003 Off-patent....... FDA.............. N/A............. Recommend consultation with
scientific community concerning
diagnosis and treatment of
pediatric hypertension and the
role of diuretics in treatment.
Vincristine................... Cancer........... 2004 Off-patent....... NICHD............ NICHD Clinical studies being conducted
Partnership by Children's Oncology Group with
with NCI/ National Cancer Institute to
Children's better define safety, efficacy,
Oncology Group. and PK.
Zonisamide*................... Partial Seizures. 2005 On-patent........ FNIH, NICHD...... N/A............. Written Request referred to FNIH.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Key: Drug is the generic name. Indication summarizes the indication or condition for which the drug is to be tested. Listing notes the year in which the
drug was added to the list for testing. Patent Status is the on- or off-patent status of the drug. WR indicates a Written Request has been issued by
the FDA and denotes where the request for and the processing of information currently resides (FDA, Foundation for NIH (FNIH) or NIH). Request for
Proposals (RFP) indicates the RFP was published by NICHD and its current status. Clinical Trial Primary Site identifies the institution that has
received the contract and has designed and implemented the preclinical or clinical protocol. Clinical Trial Design indicates in general terms the
format of the proposed or actual preclinical or clinical trials and the phases of drug development being conducted. N/A refers to a process that is
not applicable to a particular drug at this time. NHLBI is the National Heart, Lung, and Blood Institute; NCI is the National Cancer Institute; NIEHS
is the National Institute of Environmental Health Sciences; NIMH is the National Institute of Mental Health; and NCTR is the National Center for
Toxicological Research, part of the FDA.
* Indicates that a drug is currently on-patent and will be studied under a different funding mechanism than the off-patent process as described in the
BPCA Legislation of 2002. For an on-patent drug, if the manufacturer has denied or failed to respond to the WR issued by the FDA in 120 days, the FDA
refers the drug to the FNIH and requests that it be considered for FNIH support of pediatric studies. These drugs are also discussed at the annual
scientific listing meetings.
As previously stated, NICHD and the FDA have reviewed the progress
of the drugs currently listed under BPCA in addition to a review of the
entire listing process since its inception. There are drugs listed that
are currently considered inactive or are being reconsidered due to
multiple factors. Many of the factors for reconsideration are based on
feasibility issues related to clinical trial design and the overall
conduct of a study with that particular drug and/or indication--such as
frequency of condition, statistical power, and safety. A drug may also
be considered inactive if there has been a change in patent status
since its original listing. These drugs will continue to be reevaluated
throughout the year and an update will be provided no later than
January 2007.
Upon review of the BPCA listing process and based on our goal of
improving pediatric therapeutics, NIH and FDA have decided to change
our listing system to a therapeutic class-based approach. We believe
that this approach will allow us to compare drugs within a therapeutic
class (on- and off-patent) and give a broader description for the
availability and use of these drugs in children. This will also allow
us to obtain focused expertise in therapeutic areas that will
subsequently give us more insight into feasibility and study designs.
We drafted and categorized a preliminary list of drugs for the 2006
Priority List based on the newly developed condition-based approach in
an effort to identify areas in pediatrics that may contain gaps in
knowledge in the area of therapeutic options. In developing this list,
the NIH consulted with the FDA and experts in pediatric research and
practice. The following are the conditions and the drugs discussed in
our November 8-9, 2005, scientific meeting with experts in pediatric
research and determined to need more scientific evidence before studies
can be conducted in children: Attention Deficit and Hyperactivity
Disorder (ADHD), Hypertension, Parasitic Diseases, Influenza, Cancer,
Poisonings, and Sickle Cell Anemia. The drugs thought to be effective
for treatment in each of these conditions were then prioritized based
on the potential for providing a health benefit in the general
pediatric population.
ADHD was identified as a therapeutic area of interest because of
its tremendous impact on the use of psychotropic medications in
children--remaining the most commonly diagnosed behavioral disorder of
childhood. Clonidine and Guanfacine were discussed as off-patent drugs
that require further information in children. We determined that we
need further discussion with the primary care and mental health
communities to determine if studies of these agents are warranted for
the treatment of ADHD or if the primary use of these agents is as
adjunctive agents because of their sedative properties. In 2005, NICHD
learned of a published report in Cancer Letters discussing possible
cytogenetic effects in children treated with Methylphenidate
(Cytogenetic effects in children treated with methylphenidate, El-Zein,
R. et al., Cancer Letters xx (2005), 1-8.). NICHD developed a
partnership with the National Institute of Environmental Health
Sciences, the National Institute of Mental Health, the National Center
for Toxicology Research, and the FDA to further evaluate this finding.
Hypertension was identified as a therapeutic area of interest due
to the recent ``Fourth Report on the Diagnosis, Evaluation, and
Treatment of High Blood Pressure in Children and Adolescents,''
published in Pediatrics in 2004, which identified a need to determine a
treatment strategy for high blood pressure in children, especially
[[Page 23936]]
with the increasing epidemic of obesity and obesity-related diseases in
this country. The therapeutic drugs class of Diuretics (Bumetanide,
Furosemide, Hydrochlorothiazide, Spironolactone) were discussed as off-
patent drugs that require further information in children. It was
determined that we need further discussion with the pediatric experts
involved in the development of the ``Fourth Report'' to determine if,
and how, this particular class of drugs is used in primary pediatric
hypertension and how a clinical study might be structured to address
the complex issues that have recently arisen, such as obesity-related
hypertension, in the diagnosis and treatment of this disease.
Parasitic Diseases was identified as a therapeutic area of interest
due to the tremendous impact on morbidity and mortality that these
diseases have in children worldwide. Albendazole and Mebendazole were
discussed as off-patent drugs that require further information in
children. It was determined that we need to consult with domestic
(Centers for Disease Control and Prevention) and foreign sources (World
Health Organization) and other areas where these agents are
predominantly monitored and used to obtain safety information. It was
also determined that a liquid formulation of Albendazole would be
advantageous for children of developing countries, in whom these
diseases occur more often.
Influenza was identified as a therapeutic area of interest because
of the emerging threat of pandemic flu and the lack of dosing and
efficacy data in our most vulnerable pediatric population--children
less than 1 year of age. Amantidine and Rimantidine were discussed as
off-patent drugs that require further information in children. It was
determined that we need more information on the effectiveness of these
drugs to provide additional insight into the use of these agents in the
population of children less than 1 year of age.
Cancer has been identified as an ongoing therapeutic area of
interest because of the extensive morbidity and mortality that this
disease continues to exhibit in pediatric patients of all ages.
Poisoning was identified as a therapeutic area of interest due to
the fact that injuries and poisonings remain as one of the top 5
conditions that lead to the highest morbidity and mortality in young
children and adolescents.
Sickle Cell Anemia was identified as a therapeutic area of interest
because of the extensive morbidity caused by, and paucity of treatment
options for, this disease.
The following are the conditions and drugs discussed in our
November 8-9, 2005, scientific meeting with experts in pediatric
research. We will add these conditions and drugs to the 2006 priority
list for which pediatric studies are most urgently needed, along with
their indications for use:
Treatment of Pediatric Cancers: Methotrexate and Daunomycin
There is an urgent need for information regarding the
pharmacokinetics and toxicity of daunomycin in obese children. There is
an urgent need to evaluate the neurotoxicity and long-term cognitive
outcomes of children receiving methotrexate.
Treatment of Sickle Cell Anemia: Hydroxyurea
There is an urgent need for further pharmacokinetic and long-term
safety data in the use of this drug in children with sickle cell
anemia.
Treatment of Organophosphate Poisoning: Pralidoxime
There is an urgent need for further dosing information of the use
of this drug in children.
For the coming year, NICHD is planning a series of discussions with
experts in the field of pediatric cancers (NCI/COG), pediatric
infectious diseases, emergency care in pediatrics (PECARN), pediatric-
based research networks (PBRN), pediatric hypertension, and pediatric
psychiatry, in addition to our ongoing discussions with the other NIH
Institutes and Centers. The goal of these discussions will be to
specifically identify current gaps in scientific knowledge regarding
research and treatment of these various pediatric conditions, with the
ultimate goal of determining future approved drugs for which pediatric
studies are needed. NICHD will continue scientific discussions and
planning throughout 2006 and will provide an update in January 2007.
Dated: April 11, 2006.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. E6-6122 Filed 4-24-06; 8:45 am]
BILLING CODE 4140-01-P
