AHRP Comments Re: Best Pharmaceuticals for Children’s Act of 2002

Comments submitted by The Alliance for Human Research Protection Re: Best Pharmaceuticals for Children’s Act of 2002 The National Academy of Sciences Committee of the Institute of Medicine on Clinical Research Involving Children August 18, 2003 Vera Hassner Sharav, President John H. Noble, Jr., Ph.D, Treasurer David Cohen, Ph.D, Secretary…

Best Pharmaceuticals for Children Act of 2002


Comments submitted by The Alliance for Human Research Protection
to The National Academy of Sciences
Committee of the Institute of Medicine on Clinical Research Involving Children

AHRP has been closely monitoring pediatric research trends since passage of the FDA Modernization Act of 1997. We believe that medications used in children should be thoroughly tested for safety, effectiveness and appropriate dose. But unlike adults who can exercise their autonomous right to informed consent, children who are enrolled in clinical trials are non-consensual human subjects. They should not, therefore, be made to assume the burden of testing possibly toxic drugs whose safety is unknown.

Debate Resumes on the Safety of Depression’s Wonder Drugs – NYT

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Infomail Archive 2003

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ACNP and SSRI Antidepressants/ Suicidal Behavior

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References: Impact of FDA inclusion of children as test subjects

References for THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Agency for Health Care Research & Quality. (1999). Treatment of attention-deficit/hyperactivity disorder: Summary, evidence Report / Technology assessment…

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Infomail Archive Pre 2003

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