Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices

A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking. This extrapolation issue arises in the medicines context when an approved drug or device that is already being marketed is being considered (1) for new conditions (such as off-label diagnostic categories), (2) for new patients (such as new subpopulations), (3) for new dosages or durations, or (4) as the basis for approving a related drug or device (such as a generic or biosimilar drug). Although the logic of preapproval testing and the precautionary principle—first, do no harm—would counsel in favor of prohibiting extrapolation approvals until after traditional safety and efficacy evidence exists, such delays would unreasonably sacrifice beneficial uses. The harm of accessing unsafe products must be balanced against the harm of restricting access to effective products. In fact, the Food and Drug Administration\u27s (FDA\u27s) current regulations in many ways reject the precautionary principle because they largely permit individual physicians to prescribe medications for off-label uses before any testing tailored to those uses has been done. The FDA\u27s approach empowers physicians, but overshoots the mark by allowing enduring use of drugs and devices with insubstantial support of safety and efficacy. This Article instead proposes a more dynamic and evolving evidence-based regime that charts a course between the Scylla and Charybdis of the overly conservative precautionary principle on one hand, and the overly liberal FDA regime on the other. Our approach calls for improvements in reporting, testing, and enforcement regulations to provide a more layered and nuanced system of regulatory incentives. First, we propose a more thoroughgoing reporting of off-label use (via the disclosure of diagnostic codes and detailing data) in manufacturers\u27 annual reports to the FDA, in the adverse event reports to the FDA, in Medicare/Medicaid reimbursement requests, and, for a subset of FDA-designated drugs, in prescriptions themselves. Second, we would substantially expand the agency\u27s utilization of postmarket testing, and we provide a novel framework for evaluating the need for postmarket testing. Finally, our approach calls for a tiered labeling system that would allow regulators and courts to draw finer reimbursement and liability distinctions among various drug uses, and would provide the agency both the regulatory teeth and the flexibility it presently lacks. Together, these reforms would improve the role of the FDA in the informational marketplace underlying physicians\u27 prescribing decisions. This evolutionary extrapolation framework could also be applied to other contexts

Economic Education in England

Over recent years Economics as a separate subject has been in decline in England. Business Studies has grown in importance and the term Business Education is now more commonly used, in schools and colleges, to describe this area of work. This paper considers recent developments in the subject area and opportunities for further development. Particular emphasis is placed on the role of Business Education in the wider 14-19 curriculum and the prospects for future growth. The division between academic and vocationally related courses is emphasised with consideration given to the recent reform of the post-16 curriculum in England. The training of teachers in this area is outlined and implications arising from an increasing demand for teachers of Business Education is discussed

Leading international students' communities of learning within departmental extra-curricular activities: a case study in a Russell Group University in England

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Reimagining academic staff governors’ role in further education college governance

This paper aims to explore Academic Staff Governor (ASG) roles at three further education colleges in England. Uniquely, the research focuses on ASG activities, the understanding of ASG roles, and aspects of the role that can be reimagined, which may be of benefit to practising governors, particularly ASGs such as further education (FE) teacher governors. The study draws upon relevant literature to identify concepts related to governors’ roles and activities. An interpretivist stance is used to collect predominantly qualitative data through a combined methods approach, and to engage with ASGs and external governors. During fieldwork, qualitative and quantitative evidence was analysed from semi-structured interviews, questionnaire responses, observations of governance meetings and governance documents. Findings suggest that ASGs’ insiderness, their affiliation with other groups and decision-making circumstances may influence their governing activities. Activities rooted in operational settings such as professional-information giving were highly valued by other governors, while there were uncertainties about the benefit of having managerial staff as ASGs. There was evidence indicating uncertainty among the college staff regarding the role of an ASG in the colleges’ boards. As a result of the study, to conceptualise an ASG’s role in FE colleges, ‘The 3 RaPs (Roles as Position/Perceived/Practice) Framework’ for an ASG’s role has been developed. The research recommends clear and specific role descriptions for ASG posts; action to allow more opportunities for ASGs to act as governors in order to transform the scope of the role. Finally, several recommendations are set out in order to address ASGs’ insiderness, to promote ASGs’ professional profiles in the FE sector and to improve the methodological approach for use in similar future research

Reimagining academic staff governors’ role in further education college governance

This paper aims to explore Academic Staff Governor (ASG) roles at three further education colleges in England. Uniquely, the research focuses on ASG activities, the understanding of ASG roles, and aspects of the role that can be reimagined, which may be of benefit to practising governors, particularly ASGs such as further education (FE) teacher governors. The study draws upon relevant literature to identify concepts related to governors’ roles and activities. An interpretivist stance is used to collect predominantly qualitative data through a combined methods approach, and to engage with ASGs and external governors. During fieldwork, qualitative and quantitative evidence was analysed from semi-structured interviews, questionnaire responses, observations of governance meetings and governance documents. Findings suggest that ASGs’ insiderness, their affiliation with other groups and decision-making circumstances may influence their governing activities. Activities rooted in operational settings such as professional-information giving were highly valued by other governors, while there were uncertainties about the benefit of having managerial staff as ASGs. There was evidence indicating uncertainty among the college staff regarding the role of an ASG in the colleges’ boards. As a result of the study, to conceptualise an ASG’s role in FE colleges, ‘The 3 RaPs (Roles as Position/Perceived/Practice) Framework’ for an ASG’s role has been developed. The research recommends clear and specific role descriptions for ASG posts; action to allow more opportunities for ASGs to act as governors in order to transform the scope of the role. Finally, several recommendations are set out in order to address ASGs’ insiderness, to promote ASGs’ professional profiles in the FE sector and to improve the methodological approach for use in similar future research

REPORT on Research into ‘closing the gap’ : raising achievement for disadvantaged pupils

This research was commissioned by Peterborough City Council as a work stream as part of their Closing the Gap project. There is a gap in performance between children from rich and poor backgrounds in many countries, but the gap in the UK is considered to be significant (OECD, 2014; Strand 2014). Work by the Joseph Rowntree Foundation has estimated that there will be 3.5 million UK children living in poverty by 2020 (JRF, 2014). One strategy to attempt to address the problem was the introduction of The Pupil Premium by the Coalition Government in 2011 to provide additional funding to state funded schools to close the attainment gap between disadvantaged children and their peers by raising the attainment levels of those children from disadvantaged backgrounds (Ofsted, 2012)