Integrated Drug Reviews at the US Food and Drug Administration—Reply

In their Viewpoint1 about integrated drug reviews at the US Food and Drug Administration (FDA), Herder and colleagues1 noted that “in our view, integrated reviews are unlikely to achieve the agency’s stated goals and likely to introduce new problems,” referring to the goals of enhanced clarity of premarketing benefit–risk assessments and improved communication concerning approval decisions. The authors expressed concerns that there would be a loss of individual discipline reviews and dissenting viewpoints. The integrated reviews are part of the agency’s modernization initiative.2 The development process for the reviews included receipt and consideration of public comments from diverse stakeholders following a posting at Regulations.gov.3 In this Letter, we describe the purpose of integrated reviews and our assessment that they do not “circumvent [the FDA’s] legal obligation to prepare and publicly disclose individual scientific reviews.”