Working Paper No. 07-06:
Speed, Safety, and Dignity: Pediatric Pharmaceutical Development in an Age of Optimism
Date Posted: 2007
This article responds to a recent legislative invitation to reexamine the soundness of the regulations ("Subpart D") that have governed pediatric experimentation since 1983. In 1997 the Senate enacted legislation designed to ensure that the benefits of the ongoing biomedical revolution accrue to children as well as adults. Relying upon this authority, the FDA and NIH -- in 1998 and 1999 -- ordered researchers to include children in research protocols. On its face, this initiative appears unobjectionable: Do not our children deserve the best possible medical care? But, as pharmaceutical companies began to respond, it became apparent to many that this initiative was deeply flawed. The most obvious and important problem is one of long standing: If pediatricians are to have the ability -- when the time comes -- to cure the children who are not yet ill, researchers believe the presently sick must submit to experimentation. Observers query, again, whether asking one cohort to suffer for another's benefit comports with our moral sensibilities. Less obvious, but more pertinent to the structuring of our research institutions, is the challenge these orders pose to the rule that strictly limits the nature of pediatric experimentation. While one might assume that the 1998/99 orders represent an Executive repudiation of Subpart D, they do not present themselves as such. The current state of the law is, rather, that both are in force. The impending collision between these two regimes has prompted many questions from diverse perspectives. Caregivers want assurances that children's interests are protected. Researchers want to know the boundaries of the law. Legislators want to know how to revise the law so as to satisfy both these and other groups: How can we clarify legal boundaries for the research community and accommodate the speedy, safe, and dignified advance of pediatric medicine?