Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

2015 ◽  
Vol 98 (5) ◽  
pp. 502-505 ◽  
Author(s):  
A Segec ◽  
B Keller-Stanislawski ◽  
NS Vermeer ◽  
C Macchiarulo ◽  
SM Straus ◽  
...  
Keyword(s):  
Decision Making ◽  
Progressive Multifocal Leukoencephalopathy ◽  
Regulatory Decision

Voluntary food fortification policy in Australia: did ‘formal’ stakeholder consultation influence the outcome?

2021 ◽  
Author(s):  
Bronwyn Ashton ◽  
Cassandra Star ◽  
Mark Lawrence ◽  
John Coveney
Keyword(s):  
Public Health ◽  
Decision Making ◽  
Policy Process ◽  
Policy Development ◽  
Food Fortification ◽  
Policy Debate ◽  
Stakeholder Consultation ◽  
Regulatory Decision ◽  
Food Regulation ◽  
Ministerial Council

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.

Real‐world evidence to support regulatory decision making: New or expanded medical product indications

2021 ◽  
Author(s):  
Jessica M. Franklin ◽  
Kai‐Li Liaw ◽  
Solomon Iyasu ◽  
Cathy Critchlow ◽  
Nancy Dreyer
Keyword(s):  
Decision Making ◽  
Real World ◽  
Medical Product ◽  
Regulatory Decision ◽  
Real World Evidence

Use of External Controls in Regulatory Decision-Making

2017 ◽  
Vol 101 (5) ◽  
pp. 595-596 ◽  
Author(s):  
JP Jarow
Keyword(s):  
Decision Making ◽  
Regulatory Decision

Enhancing Regulatory Decision Making for Postmarket Drug Safety

2021 ◽  
Author(s):  
Vishal Ahuja ◽  
Carlos A. Alvarez ◽  
John R. Birge ◽  
Chad Syverson
Keyword(s):  
Decision Making ◽  
Operations Management ◽  
The United States ◽  
Pharmaceutical Products ◽  
Unintended Consequences ◽  
Surveillance Systems ◽  
Veterans Health ◽  
Health Administration ◽  
Regulatory Decision ◽  
Increased Risk

The U.S. Food and Drug Administration (FDA) regulates the approval and safe public use of pharmaceutical products in the United States. The FDA uses postmarket surveillance systems to monitor drugs already on the market; a drug found to be associated with an increased risk of adverse events (ADEs) is subject to a recall or a warning. A flawed postmarket decision-making process can have unintended consequences for patients, create uncertainty among providers and affect their prescribing practices, and subject the FDA to unfavorable public scrutiny. The FDA’s current pharmacovigilance process suffers from several shortcomings (e.g., a high underreporting rate), often resulting in incorrect or untimely decisions. Thus, there is a need for robust, data-driven approaches to support and enhance regulatory decision making in the context of postmarket pharmacovigilance. We propose such an approach that has several appealing features—it employs large, reliable, and relevant longitudinal databases; it uses methods firmly established in literature; and it addresses selection bias and endogeneity concerns. Our approach can be used to both (i) independently validate existing safety concerns relating to a drug, such as those emanating from existing surveillance systems, and (ii) perform a holistic safety assessment by evaluating a drug’s association with other ADEs to which the users may be susceptible. We illustrate the utility of our approach by applying it retrospectively to a highly publicized FDA black box warning (BBW) for rosiglitazone, a diabetes drug. Using comprehensive data from the Veterans Health Administration on more than 320,000 diabetes patients over an eight-year period, we find that the drug was not associated with the two ADEs that led to the BBW, a conclusion that the FDA evidently reached, as it retracted the warning six years after issuing it. We demonstrate the generalizability of our approach by retroactively evaluating two additional warnings, those related to statins and atenolol, which we found to be valid. This paper was accepted by Vishal Gaur, operations management.

Use of Artificial Intelligence in Regulatory Decision-Making

2021 ◽  
Vol 12 (3) ◽  
pp. 11-19
Author(s):  
Robert Jago ◽  
Anna van der Gaag ◽  
Kostas Stathis ◽  
Ivan Petej ◽  
Piyawat Lertvittayakumjorn ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Decision Making ◽  
Regulatory Decision
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