Transparency requires more than disclosure of data. It requires a mechanism and policy for conveying information to the public. In order for the aims of the excellent report of the FDA Transparency Working Group to be realized, a publicity initiative will need to accompany the plan of action. The FDA will need to actively convey information about the evidence concerning benefit-risk profiles of drugs, sometimes pointing out misleading claims by manufacturers or sponsors. In other cases, the FDA will need to (...) make available its procedures, including possible conflicts of interest, not only in drug approval, but also in guidance documents and in rulemaking. Transparency as a process of letting the public see into the agency should be accompanied by a proactive strategy of distributing information about the products regulated by the agency. (shrink)

The Covid‐19 pandemic highlighted the need to examine public trust in the U.S. Food and Drug Administration (FDA) vaccine approval process and the role of political influence in the FDA's decisions. Ensuring that the FDA is itself trustworthy is important for justifying public trust in its actions, like vaccine approvals, thereby promoting public health. We propose five conditions of trustworthiness that the FDA should meet when it reviews vaccines, even during emergencies: consistency with rules, proper expert or political decision‐makers, proper (...) decision‐making and noninterference, connection to public preference, and transparency of both reasons and procedures. The five conditions provide a road map of procedural and substantive requirements, which the FDA has variably implemented, focused on ensuring appropriate influence of political interests. While being a trustworthy agency cannot guarantee the public's trust, implementing these conditions builds a groundwork for public trust. (shrink)

ABSTRACT In the pages of this journal, Samuel DeCanio and colleagues have advanced the proposition that public ignorance (PI) can lead to state autonomy (SA), inasmuch as the public cannot constrain state actions of which it is unaware. The pisa framework, while original and deserving of further research, needs to take account of complicating factors on both the public ignorance and the state autonomy sides of the equation. ?Knowledge,? and thus ?ignorance,? is a matter of diverse interpretations, so what seems (...) like ignorance may actually be a form of fragmented knowledge that buttresses state autonomy. Conversely, public ignorance of state actions that would be popular if they were widely known might diminish state autonomy, by undermining the legitimacy of the state bureaucracy in question. (shrink)

Public disclosure of industry payments to physicians is one way to address financial conflicts of interest in medicine. As part of the Patient Protection and Affordable Care Act, the Physician Payment Sunshine Act requires pharmaceutical, medical device, and biologics manufacturers who have at least one product reimbursed by Medicare or Medicaid to disclose payments to physicians and teaching hospitals on a public website starting in 2014. The physician payment data will contain individual physician names, monetary values, and specific products connected (...) to payments.According to the Final Regulations issued by the Centers for Medicare and Medicaid Services in February 2013, the law will make transparent the extent and nature of relationships between physicians, teaching hospitals, and manufacturers. (shrink)

The authors respond to a letter by Mitchell Berger in the March‐April 2024 issue of the Hastings Center Report concerning their essay “Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines.”.