2005N-0404
  

  
Solicitation of Public Review and Comment on Research Protocol:
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC2
  



  

  
Submitter : 
  

  
Dr. Joseph Sanfilippo
  

  
Date & Time: 
  

  
11/03/2005 09:11:41
  



  

  
Organization : 
  

  
American Society for Reproductive Medicine
  



  

  
Category : 
  

  
Health Care Association
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 November 1, 2005

 

 

Division of Dockets Management (HFA-305)

Docket No. 2005N-0404

Food & Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Via electronic mail

 

 

On behalf of The American Society for Reproductive Medicine (ASRM), we appreciate the opportunity to submit comments in response to the October 7, 2005 Federal Register Solicitation of Public Review and Comment on Research Protocol: Gonadotropin-releasing Hormone Agonist Test in Disorders in Puberty [Docket No. 2005N-0404]. 

 

The American Society for Reproductive Medicine, founded in 1944, is an organization of approximately 8,500 physicians, researchers, nurses, technicians, and other professionals dedicated to advancing knowledge and expertise in reproductive biology and medicine.

 

The protocol being considered by the Subcommittee has been sent by the University of Chicago Institutional Review Board (IRB) to OHRP for 407 review and is authored by Robert L. Rosenfield, M.D., a pediatric endocrinologist.  It compares the sleep-related luteinizing hormone (LH) increase at puberty compared to the gonadotropin and sex steroid response to a gonadotropin releasing hormone agonist (leuprolide) test of pituitary-gonadal function. We understand there are concerns about whether the protocol would represent a ?minor increase over minimal risk in healthy children and therefore be subject to a 407 review by the OHRP.

 

We are not familiar with the specific protocol being used in this study, we do strongly support the importance of obtaining data from ?healthy? children and adolescents in order to improve our evaluation and treatment of young patients with hormonal problems.  Without data from a ?normal? population it may be difficult if not impossible, to ascertain the safety and efficacy of specific medications and treatments.  We think it is possible to move this vital research forward and to set up appropriate safeguards to protect the pediatric-adolescent patients who might be involved in these studies. We feel that diagnostic tests and use of specific pharmaceutical products are not ?minor increases over minimal risks? and therefore should not require review by a 407 panel.

 

We appreciate the opportunity to comment on this important matter in the docket.

 

Sincerely,


  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
  

Joseph S. Sanfilippo MD, MBA

President.

 

Robert W. Rebar, MD

Executive Director



  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
2005N-0404-EC2-Attach-1.DOC