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Hypoglycemia complicating diabetes therapy is well recognized to be an ever-present threat to patients, their families, providers, payers, and regulators. Despite this being widely acknowledged, the regulatory stance on hypoglycemia as an endpoint in clinical trials to support new product registration has not evolved in any meaningful way since the publication of a position paper by an American Diabetes Association (ADA) Workgroup in 2005. As the impact of hypoglycemia on persons affected by diabetes is of major importance when assessing new treatments, the historical position of regulatory agencies on hypoglycemia is reviewed with respect to product approvals. The purpose of this article is to present proposals for facilitating development of therapies that reduce hypoglycemia risk through (1) development of composite measures of benefit for regulatory endpoints and (2) facilitation of the fulfillment of an unmet clinical need for reducing hypoglycemia. In view of greater comprehension of the effects of hypoglycemia, coupled with improved methodology to assess its frequency, the authors recommend: (1) a numerical cut point of

Government regulations are an increasingly important component of the environment in which firms operate. Regulations may subject firms to large costs and possibly regulatory-induced risks, both of which may have effects on stockholders' wealth. In this paper we investigate the valuation effects of Food and Drug Administration (FDA) product approvals, rejections and disciplinary decisions on the firms that operate in the food and drug industries. We find that FDA decisions have very large wealth effects. The large price changes associated with approval and rejection decisions suggest that a significant amount of uncertainty about FDA decisions is present almost up to the announcement day. These results are somewhat surprising given the lengthy period of time involved in developing and reviewing drugs and the continuous flow of information received by the market about their potential. We also find some evidence of information leaks preceding FDA announcements. With respect to disciplinary decisions, the evidence from the data suggests that stockholders experience large losses associated with FDA actions. Since these losses represent lost stream of future illegal income, it appears that ignoring FDA rules may be quite profitable for firms that are not caught.

Drugs remain a key element in the effective containment of health care costs. In 1993, 29 new drugs were approved for marketing by the US Food and Drug Administration (FDA). These entities, according to a 1993 Office of Technology Assessment study, each took on average 12 years and $359 million each to discover and develop. The FDA reported that the average review time for these entities was 26.5 months, some 3 months less than reported in 1992. Under the prescription Drug User Fee Act of 1992, which will generate an additional $327 million over the period 1993–1997, the FDA will hire an additional 600 review staff.