Keeping Our Kids Healthy: Pediatric Medicine Development

by Searcy Denney Scarola Barnhart & Shipley

Children are a precious commodity and it is important that they are cared for appropriately. Children deserve the best care so they can grow and live happy and fulfilled lives. Pediatric products development is in high demand but industry reluctance to test products on children has been a detriment to advancements in pediatric research.

According to the Food and Drug Administration (FDA), drugs used by children are less scrutinized by the agency than drugs created for adults. Eighty percent of listed medication labels have dosing information regarding children. Only 38% of drugs that could be theoretically beneficial for pediatric use were labeled for children when originally approved. In the past few decades, studies on children were highly discouraged due to many factors:

  • Ethical complications of studying children
  • Lack of consent when conducting research
  • Fear of hurting the children in some way
  • Increased liability on the organization testing the children
  • Lack of facilities/funding/staffing/regulations for testing children
  • The drug market for children has  less demand compared to the adult market
  • High cost, low profit

There is a common myth that dosages for children can be determined by their weight compared to adult dosages because they are “little adults.” This is a  fallacy. Children are not “little adults” because their anatomy and physiology is still developing, whereas, a fully-grown adult has already achieved full physiological development. It is more unethical to give a child medication that hasn’t been properly tested for children. A more ethical way of treating a child’s illness with adult medication is to fully research and study the effects of a medicine on a child’s body.


                                                                 Courtesy of Robert Lawton.

The main goal of furthering research development for children is to save lives. Many children cannot receive treatment due to certain medications being approved only for adult use. If certain therapies can be potentially beneficial or can save lives, then clinical trials should start immediately

The demand for pediatric products development has driven Congress to make important decisions over how the FDA regulates medicines for children. The Food and Drug Administration Amendments Act of 2007 (FDAAA) added amendments to several existing pieces of legislation already regulating the FDA. These amendments allowed the FDA more easily evaluate and approve new drugs and devices for children. Other key pieces of legislation currently improving how the FDA evaluates pediatric drugs and devices include the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).

The BPCA encourages more research and development children’s therapies. The PREA helped reaffirm the FDA’s authority to mandate studies for children regarding medical products. Under the PREA, the FDA can waive studies for children if the agency finds them unneccesary. In addition, when Congress authorized the Food and Drug Administration Safety and Innovation Act (FDASIA), it granted the FDA new authority, such as granting extensions for pediatric studies at the patron’s appeal if there is good reason for the delay. Since the enactment of the FDAAA and its other provisions, the percentage of drugs approved only for adults being used in children has dropped from 80% to 50%, demonstrating the excellent results from 2007 to now.

Congress and the FDA see the importance of progress in pediatric medicine development. With  their help and our input as citizens, we can make significant changes to help save the lives of sick children.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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