The Complications of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug Safety

Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan L.; Nall, Clayton

doi:10.1111/j.1540-5907.2011.00544.x

Cited by 82 publications

(66 citation statements)

References 40 publications

(39 reference statements)

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“…One suggests that the key variable in the expansion of global norms is through regional mechanisms. Another is that important global players establish rules that then are, either through processes of “closeness” to global norm builders [51]. The underlying causes of “bureaucratization” or “rationalization” of the state apparatus as DiMaggio and Powell so famously described regulatory standardization in the 1980s [52] appears in the case of the globalization of pharmaceutical standards to have far less reach.…”

Section: Discussionmentioning

confidence: 99%

Global pharmaceutical regulation: the challenge of integration for developing states

Pezzola

Sweet

2016

Global Health

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BackgroundThis paper has set out to map the state of pharmaceutical regulation in the developing world through the construction of cross-national indices drawing from World Health Organization data. The last two decades have been characterized by deep changes for the pharmaceutical sector, including the complete transformation of intellectual property systems at the behest of the World Trade Organization and the consolidation of global active ingredient suppliers in China and India. Although the rules for ownership of medicine have been set and globally implemented, we know surprisingly little about how the standards for market entrance and regulation of pharmaceutical products have changed at the national level. How standardized are national pharmaceutical market systems? Do we find homogeneity or variation across the developing world? Are their patterns for understanding why some countries have moved closer to one global norm for pharmaceutical regulation and others have developed hybrid models for oversight of this sector? Access to medicine is a core tool in public health. This paper gauges the levels of standards in public and private generics markets for developing countries building on national-level pharmaceutical market surveys for 78 countries to offer three indicators of market oversight: State Regulatory Infrastructure, Monitoring the Private Market and Public Quality Control. Identifying the different variables that affect a state’s institutional capacity and current standard level offers new insights to the state of pharmaceuticals in the developing world. It is notable that there are very few (none at the time of this paper) studies that map out the new global terrain for pharmaceutical regulation in the post-TRIPS context.ResultsThis paper uses item response theory to develop original indicators of pharmaceutical regulation. We find remarkable resistance to the implementation of global pharmaceutical norms for quality standards in developing states and in regulatory infrastructure. Human capacity across many developing countries remains limited. Most notably, variation among states is stark. Countries that have been leaders in establishing global norms do not appear to have influenced their neighbors in establishing regional patterns. Finally, in contrast to traditional theories of international norms diffusion, global standard-setters such as the United States or European Union appear to have surprisingly little influence on standard setting across our survey.ConclusionsOur research has implications for the framing of technical support on public health initiatives aimed at strengthening local public institutions in medicine and offers a new methodological approach for analyzing drug regulation systems in developing countries.Electronic supplementary materialThe online version of this article (doi:10.1186/s12992-016-0208-2) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Global pharmaceutical regulation: the challenge of integration for developing states

Pezzola

Sweet

2016

Global Health

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“…The high level of support from stakeholder and clientele groups, in turn, further increased the agency's reputation among the Commission and the member states (cf. Carpenter et al 2012). …”

Section: The Early Development Of Ema and Efsamentioning

confidence: 93%

Agency Autonomy Actually: Managerial Strategies, Legitimacy, and the Early Development of the European Union's Agencies for Drug and Food Safety Regulation

Groenleer

2014

International Public Management Journal

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In recent decades, a series of regulatory agencies has been created at the European Union (EU) level. The existing literature on EU agencies focuses either on autonomy as a reason for the creation of such agencies or on the autonomy that they are granted by design. As a result, we do not know much about how EU agencies' actual autonomy comes about. This article therefore probes into the early development of two specific agencies. On the basis of document analysis and interviews with agency staff members, national experts, EU officials, external stakeholders, and clients, it explores why, in practice, the European Medicines Agency (EMA) seems to have developed a higher level of autonomy than the European Food Safety Authority (EFSA), even though on paper EMA appears to be as autonomous as, or if anything, less autonomous than EFSA. The article demonstrates the importance of investigating the managerial strategies of EU regulatory agencies to understand the actual practice of their autonomy and points to legitimacy as a key condition affecting the early development of such agencies.

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“…This tradeoff between high discretion, allowing frontline bureaucrats to use their expertise, and low discretion, ensuring a more specific policy implementation, is a classic but topical dilemma (15)(16)(17). However, there is very little evidence on whether high or low discretion affects policy outcomes (18).…”

mentioning

confidence: 99%

Increasing instruction time in school does increase learning

Andersen

Humlum

Nandrup

2016

Proc. Natl. Acad. Sci. U.S.A.

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Increasing instruction time in school is a central element in the attempts of many governments to improve student learning, but prior research-mainly based on observational data-disputes the effect of this approach and points out the potential negative effects on student behavior. Based on a large-scale, cluster-randomized trial, we find that increasing instruction time increases student learning and that a general increase in instruction time is at least as efficient as an expert-developed, detailed teaching program that increases instruction with the same amount of time. These findings support the value of increased instruction time.education | randomized controlled trial | school performance | school resources

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The Complications of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug Safety

Cited by 82 publications

References 40 publications

Global pharmaceutical regulation: the challenge of integration for developing states

Global pharmaceutical regulation: the challenge of integration for developing states

Agency Autonomy Actually: Managerial Strategies, Legitimacy, and the Early Development of the European Union's Agencies for Drug and Food Safety Regulation

Increasing instruction time in school does increase learning

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