The Milbank quarterly
-
The Milbank quarterly · Sep 2019
Culture, Race, and Health: Implications for Racial Inequities and Population Health.
Policy Points Racism is a fundamental cause of health inequities and disease, which requires policy solutions that address this cause directly rather than only targeting mechanisms. Cultural systems, such as cultural racism, undergird the social conditions that shape racial inequities in health, including social and health policy decision making, governance, practice, and public reception. Policies targeting racial health equity benefit from integrating social theory and meaningful assessments of the social context concerning race, racism, and health.
-
The Milbank quarterly · Sep 2019
Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015.
Policy Points Food and Drug Administration (FDA) advisory committee recommendations and the agency's final actions exhibit high rates of agreement, with cases of disagreement tending to reflect the proposed action type and degree of advisory committee consensus. In the case of disagreements, the FDA tended to be less likely than its advisory committees to approve new products, approve new supplemental indications, or enact new safety changes. These findings raise important issues regarding the factors that differentially shape decision making by advisory committees and the FDA as an agency, including institutional or reputational concerns.
-
The Milbank quarterly · Sep 2019
FDA Sodium Reduction Targets and the Food Industry: Are There Incentives to Reformulate? Microsimulation Cost-Effectiveness Analysis.
Policy Points The World Health Organization has recommended sodium reduction as a "best buy" to prevent cardiovascular disease (CVD). Despite this, Congress has temporarily blocked the US Food and Drug Administration (FDA) from implementing voluntary industry targets for sodium reduction in processed foods, the implementation of which could cost the industry around $16 billion over 10 years. We modeled the health and economic impact of meeting the two-year and ten-year FDA targets, from the perspective of people working in the food system itself, over 20 years, from 2017 to 2036. Benefits of implementing the FDA voluntary sodium targets extend to food companies and food system workers, and the value of CVD-related health gains and cost savings are together greater than the government and industry costs of reformulation.
-
The Milbank quarterly · Sep 2019
Linking Practice Adoption of Patient Engagement Strategies and Relational Coordination to Patient-Reported Outcomes in Accountable Care Organizations.
Policy Points Accountable care organizations (ACOs) have incentives to promote the adoption of patient engagement strategies such as shared decision making and self-management support programs to improve patient outcomes and contain health care costs. High adoption of patient engagement strategies among ACO-affiliated practices did not improve patient-reported outcomes (PROs) of physical, emotional, and social function among adult patients with diabetes and/or cardiovascular disease over a one-year time frame, likely because implementing these strategies requires extensive clinician and staff training, workflow redesign, and patient participation over time. A dominant focus on improving clinical measures to meet external requirements may crowd out time needed for care team members to address other outcomes that matter to patients, including PROs. Payers and policy-makers should explicitly incentivize the collection and use of PROs when contracting with ACOs.
-
The Milbank quarterly · Sep 2019
Pharmaceutical Drugs of Uncertain Value, Lifecycle Regulation at the US Food and Drug Administration, and Institutional Incumbency.
Policy Points The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use. Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA-as a regulatory institution-encounters in enforcing PMRs. Through a series of interviews with FDA leadership, this article analyzes and situates those challenges in the midst of political threats to the FDA's public health mandate.