W2 - The Potential Impact of Regulation on Innovation in the Drug Industry: The QT IssueChino 2 10:30 am - Noon
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| Chair(s): Ragnar Lofstedt
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W2.1 Risk acceptability and drug development: presentation and discussion of intermediary results from a study of the risks related to the duration of the QT interval. F.E. Bouder; King's Centre for Risk Management, King's College London frederic.bouder@kcl.ac.uk
Abstract: The QT interval is a reflection of how long it takes to “recharge” heart cells after they have been stimulated to beat. It can be affected by natural circumstances but also following clinical administration of drugs. In extreme cases drug-induced prolongation of the QTc interval can lead to death.
Calculation of Qtc has been used a convenient biomarker and therefore has influenced decisions about acceptable levels of risk. The Regulator, Business and Civil Society have been looking very differently at the risks related to the prolongation of the QT interval. The discrepancy between probabilistic risk estimates developed by the Industry and the regulator’s analysis has resulted in lack of communication and tough regulations with very tangible and massive loss for the pharmaceutical industry.
The paper will provide insights on how regulatory processes effectively work in the pharmaceutical area. It will look at:
· The attitudes and preferences of American and European regulators, Industries and Civil society towards the risks associated with the QT interval, drawing mainly on their discourses and communication strategies.
· The review will also be the basis for an identification of trust or lack of trust between the regulatory authorities and the industry.
The paper will report preliminary results from a study based on:
· Content media and literature analysis of regulatory and risk communication approaches in relation to the QT interval issue
· Face-to-face detailed “ethnographic” interviews with key players from regulatory authorities, industry, Civil Society and subject matter experts.
The paper will be a background document to a symposium at the conference. It will serve as a basis for an exchange of views between experts and will present the regulatory and the industry perspectives.
It will seek to explore risk communication in this area.
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W2.2 The Potential Impact Of Regulation On Innovation In The Drug Industry: A Business Perspective.. D Slavin; Pfizer Inc. feb50@hotmail.com
Abstract: This abstract is a contribution to the workshop proposal submitted by Professor Ragnar Lofstedt on the potential impact of regulation on innovation in the drug industry.
For companies, such as Pfizer, the complexity of regulatory processes and considerations create a difficult environment in which regulatory decisions, for example about whether a drug should be allowed on the market, can be predicted. The immense time and money required for drug discovery and development makes it essential to better comprehend decisions from the regulator, however. A particular example relates to uncertainty regarding changes in the EKG attributed to drugs. Risk aversion on the regulator’s side for any substance that could produce a small lengthening of the QT interval is a tangible and massive loss for the pharmaceutical industry. It is also disincentive to innovation. It has been for example highlighted that QT related issue was a reason for the elimination of new drug candidates in a large number of cases. The importance given to small changes in QT interval, given the uncertainty regarding the risk, seems at odds with the willingness of physicians and patients to get access to new treatments; and industry to be innovative – both with new products and safety biomarkers.Therefore it is justified to ask: is the current policy and regulatory process efficient? Could it be improved in order to become more business friendly?Pfizer will provide a business perspective on existing strategies for dealing with risk and uncertainty. The following questions to be discussed: -- What are the key determinants of the business attitude and preferences towards risk, in particular risks related to the QT interval?-- How could communication between stakeholders be improved in order to integrate better consideration about innovation and patients preferences?
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W2.3 The Potential Impact Of Regulation On Innovation In The Drug Industry: The Legal Approach.. E.D. Elliott; Yale Law School delliott@willkie.com
Abstract: Author: Professor Donald Eliott , Yale Law School. This abstract is a contribution to the Workshop proposal submitted by Professor Ragnar Lofstedt on the potential impact of regulation on innovation in the drug industry.
The regulation of pharmaceuticals has been a success story in terms of safety achievements when compared to other areas of regulation. However, it has been traditionally argued in industry circles, and more recently in regulatory circles, that this development is leading to a tangible and massive loss for the pharmaceutical industry and a limit to innovation. Considering the number of new drugs that were not allowed on the market on the basis of possible side effects, it is clear that potentially negative effects can be observed on business. The question is therefore: is this justified. Were these apparently tough decisions proportionate? Or does it mean that the safety requirements are becoming too restrictive and not sufficiently balanced? What are the tangible risks and benefits for the public both in terms of safety and access to new treatment? This contribution will provide a regulatory perspective on a study written by the King’s Centre for Risk Management of the risks related to the duration of the QT interval. It will pay specific attention to:-- The legal and regulatory environment of pharmaceuticals, including liability issues --The impact of scientific estimates and other factors on regulatory decisions about pharmaceutical risks -- “Best practices” models in the pharmaceutical area in order to guarantee at the same time high safety standards for patients and an innovation friendly environment.
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