205 medicines in the pipeline for children

August 1, 2001

Pharmaceutical Representative

A new survey by the Washington-based Pharmaceutical Research and Manufacturers of America found that 205 medicines are currently in the pipeline to meet the special needs of children and that clinical trials on an additional 40 medicines will begin in the near future.

A new survey by the Washington-based Pharmaceutical Research and Manufacturers of America found that 205 medicines are currently in the pipeline to meet the special needs of children and that clinical trials on an additional 40 medicines will begin in the near future.

"This intensive research activity offers hope that the vast improvement in children's health achieved over the past few decades will continue to accelerate," said PhRMA President Alan F. Holmer.

Just in the past year, 12 new medicines have been approved for children, including treatments for asthma, cystic fibrosis, influenza, kidney transplantation, epilepsy, attention deficit/hyperactivity disorder, HIV infection, anxiety and Lyme disease, Holmer noted.

The new medicines in development for children include:


•Â Thirty-two for cancer, a leading killer of children. Leukemia, brain tumors, bone cancers, lymphomas and other forms of cancer are targeted.


•Â Fourteen for mental illness. According to the Alexandria, VA-based National Mental Health Association, one in five children and adolescents may have a mental health problem.


•Â Thirteen for cystic fibrosis, a genetic disease that affects approximately 30,000 children and young adults in the United States.


•Â Thirteen for asthma, the most common chronic disease of childhood.


•Â Seven for AIDS and related disorders.

Research incentives

Pharmaceutical companies are also conducting studies to generate more information about medicines that are not specifically approved for children. Under a pediatric research incentive program set up by Congress in 1997, the research-based industry has proposed studies on over 200 medicines, and the Food and Drug Administration has issued 188 written requests specifying the types of studies that need to be done.

"Thanks to these studies, 28 medicines have been evaluated under the incentive program, and important labeling changes have resulted in new formulations for smaller pediatric patients, new dose recommendations to improve effectiveness and safety, and special precautions about use of medicines in certain other pediatric populations," said Holmer. "This incentive program should be extended by Congress beyond the January 2002 sunset to encourage research on the safe and proper use of medicines in children." PR

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