1 ADHD, Drug Labels, and the FDA: The Continuing Pre-Emption of Public Health

Last week, two separate advisory committees of the Food and Drug Administration assembled in the suburbs of Washington to discuss the risks of existing or proposed treatments for the condition known as Attention Deficit Hyperactivity Disorder, or ADHD. Contrary to the major news reports – namely, that the FDA hearings were convened for the purpose of discussing the safety of psychostimulants – the primary objective of the FDA appears to have been the consolidation of weaker drug labels. As such, the recent ADHD hearings were an important test run of policy revisions which are being implemented in support of the FDA’s doctrine of federal preemption. Beginning in 2002, the FDA initiated a practice of intervening on behalf of drug companies in litigation where plaintiffs attempted to recover damages for medication-related injuries. Under the policy of implied preemption, the Food and Drug Administration has maintained that the very act of approving a drug and preparing its label precludes any subsequent claims by litigants at the State level. What is preempted is the attempt of individuals to obtain compensation for damages which arise from a manufacturer’s or clinician’s failure to warn about hazards associated with medical treatments. The FDA’s preemption policy provides the crucial context for understanding the timing and perceived urgency of new rules for prescription drug labeling. On January 24, 2006, the agency published revised regulations for the content and format of prescribing information. Critics have feared that these changes will weaken the ability of the FDA to demand pertinent drug product precautions (such as Black Box Warnings, contraindications, or both). Although the changes will not take effect until the end of June, their pending implementation strongly influenced the recent proceedings of the advisory committees when they considered drug treatments for ADHD