PRIVATE LEGISLATION AS A STRATEGY OF POLITICAL NEGOTIATION

This article contributes to the perception of the role of the legislator as political initiator in modern parliamentarianism. Most of the research literature relates to the parliament member as a ‘eam player’ of their faction and party. This research was conducted into the functioning of the Israeli parliament The Knesset and into private members' legislation. The article examines in an innovative way the act of legislation, not only as a judicial or procedural process but as a process of political negotiation. The concept and findings that arose from the study of the role of the legislator as initiator of bills and negotiator with the government gives important knowledge and perspective on legislation as a political negotiation process.     

The Effect of Salient Reputational Threats on the Pace of FDA Enforcement

Do reputational concerns affect the duration of enforcement decisions? We analyze “time to decision” in warning letter processes by two enforcement divisions within the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research. We find that nearly all criticism of these divisions revolves around the FDA's primary consumer protection responsibilities (i.e., underenforcement), thus questioning the validity of the FDA's unique reputation. We also found that as media coverage of the FDA's consumer protection responsibilities becomes more positive, the agency takes enforcement decisions (warning letters) more slowly; in contrast, more critical media coverage leads to quicker action by the FDA. This effect is moderated by media salience; namely, it is found only for periods in which press coverage is relatively intense. An implication of this conditional relationship is an ability to assess the baseline role of reputation in the organization, namely, how concerned it is regarding its reputation in the absence of exogenous challenges.     

The Undesirability of Detailed Judicial Reasoning

In this paper we question the general practice in which Common Law based judicial systems produce detailed written decisions. The requirement to produce written court decisions is expensive and helps produce long delays. Furthermore, we show that the general applicability of detailed reasoning may be inefficient. Our method of proving this claim is to show that the individual litigants have almost nothing to gain from having a detailed written reasoning. In fact, most of the time, they are clearly better off by being able to switch to a policy that requires no written opinion. Our approach is most appropriate in circumstances of pecuniary private disputes where the parties involved act as rational utility, or profit, maximizers.     

A SCIENTIFIC STANDARD AND AN AGENCY’S LEGAL INDEPENDENCE: WHICH OF THESE REPUTATION PROTECTION MECHANISMS IS LESS SUSCEPTIBLE TO POLITICAL MOVES?

This article presents a model that introduces a scientific ‘gold’ standard as a reputation protection mechanism operating alongside an agency’s legal independence. It tries to gauge which of the two is less susceptible to political moves. The model suggests that the scientific ‘gold’ standard for agency decisions is less susceptible to political moves because of its important role as a legitimating device for both government ministers and regulators. Government ministers are able to address multiple audiences and even to respond to aggressive strategies by powerful interest groups by undermining one reputation protection mechanism (that is, an agency’s independence) without weakening the other (that is, the scientific barrier for granting full‐subsidy status to treatments that lack comparative therapeutic advantage). This implies that drug reimbursement mechanisms that provide a high quality of drug evaluation are designed to be effective.     

Organizational Reputation and Jurisdictional Claims: The Case of the U.S. Food and Drug Administration

When do regulatory agencies expand, following the emergence of novel technologies? This article presents a verbal model that suggests that a regulator is most likely to announce that it has statutory authority to regulate a novel technology when its reputation is at stake. This is most likely to occur when (1) new information becomes available to the regulator regarding the seriousness of the anticipated harm of a novel technology, or (2) a rival regulator attempts to formalize its regulatory authority or fails to do so although officially required to. A historical–institutional analysis of the temporal process leading to jurisdictional claims by the U.S. Food and Drug Administration over gene therapy, laboratory‐developed complex diagnostic tests, human tissue transplants, and human cloning supports the model's prediction.     

Organizational Reputations and the Observability of Public Warnings in 10 Pharmaceutical Markets

How does a regulator's reputation affect the public observability of its regulatory errors? I present a verbal model in the policy domain of drug safety that suggests that media coverage of the regulator's errors is a function of the regulator's predominant basis of reputation. Media coverage will be lowest when the regulator has a reputation for scientific expertise in preapproval drug evaluation (or when it “shadows” decisions made by regulators that have reputation for expertise) and highest when it has a reputation as a guarantor of public safety in the media. Empirical tests of the model in the United States, the United Kingdom, Germany, Canada, South Africa, Australia, New Zealand, Ireland, Israel, and Switzerland between 1975 and 2004 supports the model's prediction and therefore, undermine Carpenter's assumption that regulators cannot recover reputation losses resulting from the approval of a truly dangerous drug.