MEDGuide and patient package inserts--again?

This article will trace the history and effects of the PPI from the time of its original concept by the FDA in the early 1970's to its current status. It will also address the response to this FDA initiative by the industry, medical community and consumer groups. Initiatives in other countries and future issues will also be discussed.     

The State of American Federalism, 1996-1997

Federalism enjoyed political and popular salience during theperiod 1996–1997 as the so-called "Devolution Revolution"began to be implemented and analyzed in the United States. Whilethere were a few examples of important Revolutionary efforts,the federal government continued to hold much of the power andsignificance it has achieved over the past sixty years. Evenin the area of welfare policy, where in 1996 there were historicreforms enacted to end the federal entitlement, the federalgovernment maintained a significant presence that made the ideaof devolution of welfare policy responsibility some what questionable.Nevertheless, states continued to lead in policy innovationin areas ranging from education to health, and the U.S. SupremeCourt continued to question the limits of federal power. Thepast year illustrated, once again, the complexity of our federalsystem and how difficult it is to reform federalism—particularlywhen it involves a shift in power and creates the perceptionof winners and losers.     

Mental disabilities under the ADA: a management rights approach

While numerous sources have focused on employee rights and employer obligations under the Americans with Disabilities Act, this article will emphasize employer rights with respect to mental disabilities under the ADA. Specifically, it addresses the ADA's definition of "mental disability," the right of employers to screen job applicants in spite of the ADA, the conditions under which an employer may require an employee to undergo a "fitness for duty" examination, and the limits of the duty to "reasonably accommodate" an employee with a mental disability.     

Evaluating adolescent decision making in legal contexts

Challenges the use by policy researchers of a model for comparing adolescent and adult decision making that is based on informed consent standards. An expanded decision-making framework designed to evaluate judgment in adults and adolescents can better test the empirical basis of paternalistic legal policies. The theoretical and empirical literature on the informed consent framework is critiqued and an alternative framework incorporating judgment factors is proposed. Three judgment factors—temporal perspective, attitude toward risk, and peer and parental influence—and their effects on decision making are explored. Finally, implications for future research are analyzed in several decision-making contexts.Several of the ideas in this article were originally presented by the first author and were published as part of a symposium on competence (see Scott, 1992). The current article expands and refines these ideas, provides a more substantial research base, and suggests several future research directions. We thank Joseph Allen, Richard Bonnie, Baruch Fischhoff, William Gardner, John Monahan, Edward Mulvey, Richard Redding, Paul Slovic, and three anonymous reviewers for their helpful comments. Special thanks to Thomas Grisso for providing much constructive criticism and to Wendy Shang for outstanding research assistance. Finally, we would like to acknowledge the MacArthur Foundation, which supported this work in its early stages.     

As outcomes measurement and management become widespread, providers should beware of legal pitfalls

Until new statutes and court decisions clarify the law applicable to outcomes research, providers will continue to face new questions. In the meantime, paying careful attention to satisfying the requirements of existing laws protecting peer review information will put providers in the best position to minimize their exposure. Providers should review their current outcomes measurement and management systems to ensure that (1) they are structured to take full advantage of the confidentiality protections available under state law, and (2) appropriate access to outcomes data for those who need it is clearly provided for in the relevant documentation.