[Federal Register Volume 70, Number 59 (Tuesday, March 29, 2005)]
[Notices]
[Pages 15865-15866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0102]


Referral of KEMSTRO (Baclofen) and DROXIA (Hydroxyurea) for the 
Conduct of Pediatric Studies

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
referral of KEMSTRO (baclofen) and DROXIA (hydroxyurea) to the 
Foundation for the National Institutes of Health (the Foundation) for 
the conduct of pediatric studies. FDA referred KEMSTRO (baclofen) and 
DROXIA (hydroxyurea) to the Foundation on September 1, 2004, and 
October 20, 2004, respectively. FDA is publishing this notice of the 
referrals in accordance with the Best Pharmaceuticals for Children Act 
(BCPA).

FOR FURTHER INFORMATION CONTACT:  Grace Carmouze, Center for Drug 
Evaluation and Research (HFD-960), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-7337.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 4 of the BPCA (Public Law 107-109), FDA 
is announcing the referral to the Foundation of the written requests 
for the conduct of pediatric studies for KEMSTRO (baclofen) and DROXIA 
(hydroxyurea). Enacted on January 4, 2002, the BPCA reauthorizes, with 
certain important changes, the exclusivity incentive program described 
in section 505A of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 355a). Section 505A of the act permits certain applications 
to obtain 6 months of exclusivity if, in accordance with the 
requirements of the statute, the sponsor submits requested information 
relating to the use of the drug in the pediatric population.
    The BPCA established additional mechanisms for obtaining 
information on the safe and effective use of drugs in pediatric 
patients. Specifically, section 4 of the BPCA amends section 505A(d) of 
the act to create a referral process to obtain studies for drugs that 
have patent or exclusivity protection, but for which the sponsor has 
declined to conduct the pediatric studies in response to a written 
request by FDA. Under section 4 of the BPCA, if the Secretary of Health 
and Human Services (the Secretary) determines that there is a 
continuing need for the pediatric studies described in the written 
request and the sponsors of the products with patent or exclusivity 
protection have declined to conduct the studies, the Secretary shall 
refer the drug to the Foundation, established under section 499 of the 
Public Health Service Act (42 U.S.C. 290(b)), for the conduct of the 
pediatric studies described in the written request (21 U.S.C. 
355a(d)(4)(B)(i)). In addition, the BPCA requires public notice of the 
name of the drug, name of the

[[Page 15866]]

manufacturer, and indications to be studied under the referrals (21 
U.S.C. 355a(d)(4)(B)(ii)).
    In accordance with section 4 of the BPCA, FDA is announcing that it 
has referred to the Foundation the written requests for pediatric 
studies for KEMSTRO (baclofen) and DROXIA (hydroxyurea). On April 30, 
2004, FDA issued a written request for pediatric studies to Schwarz 
Pharma, Inc., the holder of approved applications for KEMSTRO 
(baclofen) that have market exclusivity. The studies described in the 
written request were for the treatment of spasticity in the pediatric 
population. Schwarz Pharma, Inc., declined to conduct the requested 
studies. FDA has determined that there is a continuing need for 
information relating to the use of KEMSTRO (baclofen) in the pediatric 
population.
    On March 29, 2004, FDA issued a written request for pediatric 
studies to Bristol-Myers Squibb Co., the holder of approved 
applications for DROXIA (hydroxyurea) that have market exclusivity. The 
studies described in the written request were for the treatment of 
sickle cell disease in the pediatric population. Bristol-Myers Squibb 
Co. declined to conduct the requested studies. FDA has determined that 
there is a continuing need for information relating to the use of 
DROXIA (hydroxyruea) in the pediatric population.
    Consistent with the provisions of the BPCA, FDA referred to the 
Foundation the written requests for the conduct of the pediatric 
studies for KEMSTRO (baclofen) on September 1, 2004, and DROXIA 
(hydroxyurea) on October 20, 2004.

    Dated: March 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6158 Filed 3-28-05; 8:45 am]
BILLING CODE 4160-01-S