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The U.S. has the tools to end the HIV epidemic, but progress has stagnated. A major gap in U.S. efforts to address HIV is the under-utilization of medications that can virtually eliminate acquisition of the virus, known as pre-exposure prophylaxis (PrEP). This document proposes a financing and delivery system to unlock broad access to PrEP for those most vulnerable to HIV acquisition and bring an end to the HIV epidemic.
The complexity and inefficiency of the U.S. health care system complicates the distribution of life-saving medical technologies. When the public health is at stake, however, there are alternatives. The proposal for a national PrEP program published in this issue of the Journal applies some of the lessons of the national COVID vaccine campaign to HIV prevention. In doing so, it draws on other examples of public health approaches to the financing of medical technology, from vaccines for children to hepatitis C treatment.
Egilman et al. review the current data sharing practices of three global regulatory agencies — Health Canada, the European Medicines Agency and the Food and Drug Agency. While there has been progress towards increasing transparency over the past decade, progress has been slow.
The U.S. Food and Drug Administration (FDA) 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.
To 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.
In 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.
The team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.
The development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation.