Children are not just small adults. They have unique health and developmental characteristics that affect how they respond to food and medical products. Regulatory science at FDA holds great promise for bridging the gap in our scientific knowledge about how medical treatments affect children and developing new therapies on their behalf. Although developmental biology and studies of children are active areas of biomedical research, findings are often not translated into product development or clinical studies that assess children as a distinct and separate subpopulation. To provide children with proper nutrition and safe and effective medications, we must understand the effects of growth and how children differ from adults in metabolism, behaviors and hormonal influences.
What has FDA done?
FDA has been committed to addressing the special considerations needed for assessing medical products for children and young adults. These include science to address how development, age and growth may affect how treatments work and effect health outcomes in children. FDA has focused attention on the science required for addressing how drugs behave in children and worked to design studies to address these concerns. Through a combination of legislation, particularly the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), and scientific work both within and outside of FDA, many studies have been conducted to assess how drugs behave in children versus adults. These studies have resulted in labeling changes for over 350 marketed medical products, including those noting differences in unique pharmacokinetics, dosing adjustments, and enhanced safety information for children. One such study is noted below.
- Addressing adolescent suicide resulting from antidepressant use
For years, some patients being treated for depression with antidepressants reported having suicidal thoughts and in many cases attempted suicide. This led to the belief that antidepressants may have an “activating effect” that allows patients to follow through on their suicidal impulses. Several studies conducted in the 1990s concluded that there was, in fact, no link between antidepressants and the risk of completed suicide. However, in 2003, data from several pediatric trials were analyzed and suggested that antidepressants may have led to attempted suicide and increased suicidal tendencies in children. After an FDA-convened advisory committee meeting in 2004, the FDA embarked on its own investigation of the data collected by eight industry sponsors of 12 marketed antidepressant products. Data were compiled from 372 clinical trials with 99,231 participants, much of which was unpublished sponsor data that had not been utilized in previous studies.
The results of this extensive effort of multi-study comparisons by the FDA resulted in several important findings and conclusions. First, there was no evidence of increased suicide risk in the adult population taking anti-depressants. However, when the studies were analyzed by age, an increased risk of suicide was found in adults under 25 years old. This study prompted an understanding that suicidal thoughts and completions tied to antidepressants are age-dependent with increased risk in people under 25, no effect in ages 25-65 and a potentially favorable effect on reducing suicide in adults over age 65. This resulted in FDA placing warnings on the labeling and medication guides. Without the ability to combine data from multiple clinical studies and to use analytical tools and advanced statistics to assess these data, this important finding would not have been made.
What can FDA do with increased investment in regulatory science?
Regulatory science provides the opportunity to examine the unique biology of children, apply that understanding to the science of product development and evaluation – and keep our kids safe and healthy. Here are some ways in which we can safeguard the next generation:
- Ensuring the safety of medical products
FDA has already begun this work through projects such as the Safety of Key Inhaled and Intravenous Drugs in Pediatrics Initiative, which is examining the effects of sedatives and anesthetics on children and infants. The project will have a significant effect on pediatric and child health — more projects like this are urgently needed.
- Securing our food supply
Children are particularly vulnerable to food-borne pathogens. They are more likely to get sick, even die, from food-borne illness than the general population. A major focus of FDA’s interest in regulatory science is the development of more rapid and practical methods for detecting microbial pathogens in food and equipping FDA’s labs to test multiple food samples for contaminants at once. In addition, FDA must enhance the scientific understanding of the causes of food-borne illness so that feasible interventions can be designed and implemented to effectively reduce risk.
- Preventing tobacco use in children and youth
We know that efforts to prevent tobacco use are particularly effective when targeted at children and youth. With new authorities granted under the Family Smoking Prevention and Tobacco Control Act, FDA can propose and implement restrictions on advertising and marketing targeted to children and youth to reduce initiation of tobacco use. FDA needs to enhance its understanding of which industry activities have the greatest effect on youth smoking to promote regulatory efforts to block them. Measuring the effects of these actions on initiation will make sure that FDA is able to meet its goals.
- Combating obesity
More than 17 percent of children and youth under age 20 are obese, putting them at risk for cardiovascular disease, type 2 diabetes and other chronic diseases. This makes clear the critical importance of FDA’s authority over food labeling, an essential means for informing consumers about the nutrition content of their foods. Health reform legislation signed into law by President Obama extends nutrition labeling requirements to chain restaurants and vending machines. To most effectively exercise this authority, FDA must engage in scientific analyses to determine what type of food labeling is most useful to consumers who want to make healthy choices.
- Understanding the risk of toxins
As they develop and grow, infants and children need to be protected from exposure to dangerous levels of toxins in the foods they eat, the medical products they use and other products they come into contact with. FDA’s National Center for Toxicological Research is committed to identifying these toxins and reducing the risk of adverse health effects from products on the market.
As the makeup of products becomes increasingly complex, so too must science at the FDA adapt to meet these challenges.