BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we convened (...) a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation. (shrink)

This study examines the public's and physicians' willingness to support deception of insurance companies in order to obtain necessary healthcare services and how this support varies based on perceptions of physicians' time pressures. Based on surveys of 700 prospective jurors and 1617 physicians, the public was more than twice as likely as physicians to sanction deception (26% versus 11%) and half as likely to believe that physicians have adequate time to appeal coverage decisions (22% versus 59%). The odds of public (...) support for deception compared to that of physicians rose from 2.48 to 4.64 after controlling for differences in time perception. These findings highlight the ethical challenge facing physicians and patients in balancing patient advocacy with honesty in the setting of limited societal resources. (shrink)

The growth of managed care was accompanied by concern about the impact that changes in health care organization would have on the doctor-patient relationship. We now are in a “post-managed care era,” where some of these changes in health care delivery have come to pass while others have not. A re-examination of the DPR in this setting suggests some surprising results. Rather than posing a new and unprecedented threat, managed care was simply the most recent of numerous strains on the (...) DPR that have occurred throughout the century. These strains are a constant, inevitable consequence of the varying needs and concerns of patient and physicians as they seek to balance their desires for a certain type of DPR with their simultaneous desire for other aspects of care such as lower costs, greater technological sophistication, and improved outcomes. (shrink)

Changes in healthcare financing increasingly rely upon patient cost-sharing to control escalating healthcare expenditures. These changes raise new challenges for physicians that are different from those that arose either under managed care or traditional indemnity insurance. Historically, there have been two distinct bases for arguing that physicians should not consider costs in their clinical decisions—an “aspirational ethic” that exhorts physicians to treat all patients the same regardless of their ability to pay, and an “agency ethic” that calls on physicians to (...) be trustworthy advisors to their patients. In the setting of greater patient cost-sharing, physicians' aspiration and agency roles increasingly conflict. Satisfactorily navigating the new terrain of consumer-driven healthcare requires physicians to consider these two roles and how they can best be reconciled so as to maximize quality of care while respecting the heterogeneity of patients' financial resources and willingness to pay. (shrink)

Physicians have special professional obligations to respond to medical emergencies. A bioterrorism attack would be a medical emergency. Thus, it seems that physicians would have an obligation to respond to a bioterrorist attack. However, the scope of those obligations, and their limits, are vexed topics. General rules may be comforting but the details and nuances of particular situations will always be relevant.

Physicians have special professional obligations to respond to medical emergencies. A bioterrorism attack would be a medical emergency. Thus, it seems that physicians would have an obligation to respond to a bioterrorist attack. However, the scope of those obligations, and their limits, are vexed topics. General rules may be comforting but the details and nuances of particular situations will always be relevant.