Child Health Groups, FDA Commemorate Key Milestone: 500th Drug Label Revised for Use in Children

The American Academy of Pediatrics (AAP), the Elizabeth Glaser Pediatrics AIDS Foundation (EGPAF) and the Food and Drug Administration(FDA) recentry celebrate a new milestone in child health: the 500th drug label has been revised with new pediatric information as a result of two pediatric drug laws.

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The label changes were made possible by the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). BPCA and PREA were permanently renewed and strengthened as part of the Food and Drug Administration Safety and Innovation Act, which passed last year.

As of today, 500 drug labels have been revised with pediatric information as a result of these laws for children.

“Children are not just small adults; their unique developmental and physiological needs affect how medications work for them. As a result, a child may need a different dose of a certain medication than an adult, may require new safety precautions, or may benefit from a different use of the drug altogether,” said AAP President Thomas K. McInerny, MD, FAAP. “We now have 500 drug labels that include just this type of information for children, which has not only revolutionized pediatric practice, but has also helped provide children with access to safe and effective medicines labeled especially for them.”

PREA requires drug companies to study medications in children when the product is likely to be used in a significant number of children or represents a meaningful therapeutic benefit over existing options. BPCA provides an incentive for drug companies to conduct FDA requested pediatric studies in return for an additional six months of marketing exclusivity.

“Before PREA and BPCA were enacted, only one in five drugs contained information on pediatric use,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “Today 500 drug labels contain essential information on the safety, effectiveness and dosing for use in children. While there is work that still needs to be done, this is a true milestone for FDA, for the American Academy of Pediatrics and more importantly, for the health of children.”

Until BPCA and PREA were passed in 1997 and 2003 respectively, most medicines used to treat children had only been tested for safety and efficacy in adults. Drugs studied under BPCA and PREA treat a wide range of diseases in children, including HIV/AIDS, cancer, diabetes, allergy and asthma.

“This milestone reflects the legacy of our organization, which was founded to advocate for new medications, research and legislation to help the most vulnerable patients living with HIV – children,” said Charles Lyons, EGPAF president and CEO. “We are proud to have played a role in the development of the laws responsible for this latest labeling change, and we will continue to support efforts to ensure that children have access to life-saving medicines labeled especially for their unique health needs.”

BPCA and PREA have helped reduce off-label use of drugs in children from approximately 80 percent to about 50 percent, but there is still work to be done to improve pediatric labeling, especially for the youngest children up to one month of age, neonates, where off-label use is closer to 90 percent.

“Pediatricians owe an enormous debt of thanks to the FDA for decades of tireless efforts to improve medicines for children,” said Dr. McInerny. “Today, as we celebrate this historic achievement, we renew our charge to ensure that all children can safely access the medicines they need when they need them.”

About the American Academy of Pediatrics

The American Academy of Pediatrics is an organization of 60,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults. (

About the Elizabeth Glaser Pediatric AIDS Foundation 

The Elizabeth Glaser Pediatric AIDS Foundation is a global leader in the fight against pediatric HIV and AIDS, and has reached more than 17 million women with services to prevent transmission of HIV to their babies. It currently works at nearly 6,800 sites in 15 countries to implement prevention, care, and treatment services; to further advance innovative research; and to execute strategic and targeted global advocacy activities in order to bring dramatic change to the lives of millions of women, children, and families worldwide.  (