[Federal Register Volume 69, Number 2 (Monday, January 5, 2004)]
[Notices]
[Page 366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17]



[[Page 366]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Referral of Morphine Sulfate 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 morphine sulfate to the Foundation for the National 
Institutes of Health (the Foundation) for the conduct of pediatric 
studies. FDA referred the drug to the Foundation on September 29, 2003, 
and is publishing this notice of the referral in accordance with the 
Best Pharmaceuticals for Children Act (BPCA).

FOR FURTHER INFORMATION CONTACT: Terrie Crescenzi, Office of Pediatric 
Therapeutics (HFG-2), Food and Drug Administration, 5600 Fishers Lane, 
rm. 4B-44, Rockville, MD 20857, 301-827-9218.

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 request for 
the conduct of pediatric studies for the use of intravenous (IV) 
morphine sulfate. 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 manufacturer, and indications to be 
studied pursuant to 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 the written request for pediatric studies for the IV use 
of morphine sulfate to the Foundation. On March 28, 2003, FDA issued a 
written request for pediatric studies to Faulding Pharmaceutical Co. 
and Ligand Pharmaceuticals, the holders of approved applications for 
morphine sulfate that have market exclusivity. The studies described in 
the written request were for the indication of moderate-to-severe pain 
in the pediatric population. Not later than 180 days after receiving 
the written request, Faulding Pharmaceutical Co. and Ligand 
Pharmaceuticals declined to conduct the requested studies. FDA has 
determined that there is a continuing need for information relating to 
the IV use of morphine sulfate in the pediatric population. Consistent 
with the provisions of the BPCA, on September 30, 2003, FDA referred to 
the Foundation the written request for the conduct of the pediatric 
studies for IV morphine sulfate.

    Dated: December 24, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-17 Filed 1-2-04; 8:45 am]
BILLING CODE 4160-01-S