Independent Drug Testing to Ensure Drug Safety and Efficacy

This Article explores a proposal that would preclude biased drug testing by removing all drug sponsor influence on the design and conduct of clinical trials for new drug applications (“NDAs”), a reform that would address the root of institutional corruption. Recently advocated by leading scholars, the idea has a long history, yet was neglected for over half a century due to pharmaceutical industry opposition

German Pharmaceutical Pricing: Lessons for the United States

To control pharmaceutical spending and improve access, the United States could adopt strategies similar to those introduced in Germany by the 2011 German Pharmaceutical Market Reorganization Act. In Germany, manufacturers sell new drugs immediately upon receiving marketing approval. During the first year, the German Federal Joint Committee assesses new drugs to determine their added medical benefit. It assigns them a score indicating their added benefit. New drugs comparable to drugs in a reference price group are assigned to that group and receive the same reimbursement, unless they are therapeutically superior. The National Association of Statutory Health Insurance Funds then negotiates with manufacturers the maximum reimbursement starting the 13th month, consistent with the drug\u27s added benefit assessment and price caps in other European countries. In the absence of agreement, an arbitration board sets the price. Manufacturers accept the price resolution or exit the market. Thereafter, prices generally are not increased, even for inflation. US public and private insurers control prices in diverse ways, but typically obtain discounts by designating certain drugs as preferred and by restricting patient access or charging high copayment for nonpreferred drugs. This article draws 10 lessons for drug pricing reform in US federal programs and private insurance

Health Care Consumers: Choices and Constraints

This article summarizes the research and data currently available on different dimensions of consumer choice. These dimensions include not only whether to participate in a health care plan and which plan to select if given a choice but also the decisions that lead to having a choice and the implications of making the choice. Data are presented on what choices consumers face, how many are given what kinds of choices, what constraints they face, what we know about how they make these choices, and what information they are given and what they use. The majority of Americans are offered some kind of health insurance plan either through their place of employment or as a dependent on someone else’s employer-sponsored health plan. About half of those offered health insurance are offered a choice, usually of only two or three plans. The majority elect to participate in one of those plans.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/68465/2/10.1177_107755879905600102.pd

Exit and Voice in American Health Care

Until the 1960s, the main way for patients to affect health care institutions was by choosing their doctors or hospitals or leaving those with which they were dissatisfied. They had few avenues to exert their voice to bring about change through complaints, politics, or other means. The balance between exit and voice shifted in the 1960s, as the women\u27s health and disability rights movements brought about change by increased use of political voice and, to a lesser degree, by exit. With the growth of managed care since the 1980s, enrolled individuals have had fewer opportunities for exit and greater potential to exercise voice to influence managed care organizations. However, that potential has not yet been adequately realized. Current debates about consumer rights focus on appeals of decisions by managed care organizations to deny services. They generally ignore the role of members in organizational policy or governance. This Article explores the relation between exit and voice in American health care and its prospects for the future