Barbara A. Noah

Just a spoonful of sugar: drug safety for pediatric populations.

Children deserve optimal medical care. Although prescription drugs play a prominent and essential role in pediatric health care delivery, health care providers often must make prescribing decisions for their young patients based on imperfect or absent safety and efficacy data for pediatric populations. The safe and effective use of prescription drugs in children depends on a thorough understanding of the physiologic differences between children and adults. Currently, only one-third of drugs prescribed to children have been studied for safety and efficacy in pediatric populations. Until relatively recently, the Food and Drug Administration (FDA) made surprisingly little effort to improve the quality or quantity of clinical research data for this patient group. Recent agency efforts to encourage pediatric drug research have generated mixed results and created unintended consequences. The development, prescribing, and safety evaluation of prescription drugs for children will require that the FDA and health care providers examine current practices, acknowledge their shortcomings, and consider creative solutions to the challenges associated with gathering additional data through pediatric drug research.

Foreword: Dietary Supplement Regulation in Flux

Dietary supplements -- vitamins, minerals, herbs, amino acids, and sundry other substances -- have soared in popularity over the past decade, resulting in a

The Participation of Underrepresented Minorities in Clinical Research

20 billion industry with over 1,000 manufacturers marketing 29,000 products. These products present vexing regulatory challenges for the Food and Drug Administration (FDA), and, for many years, the agency struggled to formulate an effective regulatory approach. In 1993, the FDA published a notice that summarized its safety concerns associated with various categories of dietary supplements and delineated the rather aggressive regulatory recommendations of an agency task force. Congress quickly reacted to these proposed regulatory initiatives. In 1994, it enacted the Dietary Supplement Health and Education Act (DSHEA), which sharply limits the FDAs express authority to regulate covered products. Purporting to balance concerns about the safety of supplements and consumer freedom to purchase them, DSHEAs highly deregulatory approach won effusive praise from commentators who profess strong faith in the ability of consumers to make intelligent choices about supplement use. Other observers remain dubious, however, that the typical consumer will exercise informed skepticism when it comes to claims about the safety and utility of these products.