Summary
This research aimed to understand how the policy was represented as a ‘problem’ in food regulatory decision-making in Australia, and the implications for public health nutrition engagement with policy development processes. Bacchi’s ‘what’s the problem represented to be?’ discourse analysis method was applied to a case study of voluntary food fortification policy (VFP) developed by the then Australia and New Zealand Food Regulation Ministerial Council (ANZFRMC) between 2002 and 2012. As a consultative process is a legislated aspect of food regulatory policy development in Australia, written stakeholder submissions contributed most of the key documents ascertained as relevant to the case. Four major categories of stakeholder were identified in the data; citizen, public health, government and industry. Predictably, citizen, government and public health stakeholders primarily represented voluntary food fortification (VF) as a problem of public health, while industry stakeholders represented it as a problem of commercial benefit. This reflected expected differences regarding decision-making control and power over regulatory activity. However, at both the outset and conclusion of the policy process, the ANZFRMC represented the problem of VF as commercial benefit, suggesting that in this case, a period of ‘formal’ stakeholder consultation did not alter the outcome. This research indicates that in VFP, the policy debate was fought and won at the initial framing of the problem in the earliest stages of the policy process. Consequently, if public health nutritionists leave their participation in the process until formal consultation stages, the opportunity to influence policy may already be lost.
Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018‐2019 Submissions to the US FDA's Office of Clinical Pharmacology