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EVOLUTIONARY CHANGE IN INSTITUTIONAL LOGICS:
THE CASE OF US DRUG REGULATION1
Few studies examine how institutional logics evolve over time in fields where the entry and behaviour of actors is heavily regulated. Building on a case study of the US drug industry, I proposed that regulatory logics evolve through a process of endogenously-driven change and suggest how this model may be helpful in understanding processes of institutional Introduction
Institutional logics refer to belief systems or “organizing principles” (Freidland and Ashford, 1991:248) that guide actions of members of an organizational field. The influence of institutional logics has been used to describe the organization of medical services (Scott, 2000), of college text book publishing industry (Thornton, 1995) and of savings institutions (Haveman & Rao, 1997), among other examples of social organization. In spite of the pervasiveness of institutionalist thinking in a wide range of social activity, only relatively recently have TIM scholars begun to examine the coevolution of institutional logics and technology development. Moreover, most studies investigating this phenomenon have been based on the case of a single invention (cf. for example, Garud and Rappa, 1994; Garud et al, 2002). While they may, for example, suggest how stakeholder interests, power, and politics affect the negotiation of a regulatory standard, they offer few opportunities to inform us of how a regulatory logic evolves over time as new technologies are introduced or existing ones are improved. Because regulatory policies are typically relatively long-standing traditions shaken only by disruptive “jolts” or changes to the socio-economic environment, understanding their processes of evolution can be helpful not only in developing prescriptions for regulatory compliance, but also in developing alternative theories of institutional change. While the dominant theories of institutional change (DiMaggio and Powell, 1983), such as institutional innovation (Sherer & Lee, 2002) most often attribute change to the entry of new types of actors or innovators, focussing on the evolution of logics allows us to understand how 1 I acknowledge the financial support of the Fonds québécois de recherche sur la société et la culture (FQRSC) and the Programme d'aide financière à la recherche et à la création (PAFARC) of the Université du Québec à Montréal. I thank Serghei Floricel for thoughtful comments on a drafts of this paper and Valérie Raymond for excellent research assistance. change may occur when the constitution of its institutional “field” remains relatively unchanged. Longitudinal analysis of institutional logics can therefore be a fruitful avenue for developing theories of long-run institutional change, as Haverman and Rao’s (1997) longitudinal study of Based on an analysis of the history of drug regulation in the USA, I propose that the evolution of regulatory logics is tied to the nature of problems encountered in the development and regulation of a technology. Experiences with a new product ultimately end up shaping laws and agency regulations, but because such “problems” encountered, (e.g., drug toxicity or efficacy), are products of the R&D technology being used, which is itself determined by past experiences, regulatory logics and technology development are ultimately a coevolutionary process. Though the coevolutionary hypotheses of regulation and technology development have been acknowledged at the level of technology sponsors and regulators (Garud and Rappa, 1994), few, if any studies have investigated why sponsorship or development of a new technology is merely one of many points on a long run coevolutionary development path of technology and regulation. Uncovering this mechanism of action, would thus be helpful in proposing processes of endogenous growth and technology development in regulated industries. In the US pharmaceutical industry, a logic of pre-market authorization introduced in 1938 created a category of prescription drugs, in addition to requiring that manufacturers test drugs for safety. The central thesis of this paper is that the evolution of regulatory logics is not shaped merely historical accidents, as the case of US drug regulation might suggest, but is defined by the problems a prevailing logic introduces for members of the field. More specifically, a new regulatory logic (e.g., a requirement that medicines must clinically tested prior to commercialization) creates opportunities for certain types of technological development, but also initiates unanticipated consequences which often later create a new basis for reform of regulatory logics. In this sense, changes to the drug regulation system (including recent changes to the regulation of natural health products and dietary supplements) can be thought of as being shaped Regulatory logics evolve in this way because of the role regulations play in both constraining and enabling developers of new technologies, a phenomenon Giddens (1984) referred to as “structuration”. According to Giddens, agents invoke “structures” or rules in order, for example, to launch compliant products. However, with each iteration, agents also engage in reproduction or transmutation of such structures. In this sense, the regulations are both used in the production of a new good and reproduced (or transmutated) as a system, when approval decisions are made. To explain how and why these changes occurred, I begin with an overview of the role of regulatory logics and structuration. I then present a historical overview (shortened here for space requirements) of milestones shaping US drug regulation. I then discuss how the changes in regulatory logics may be explained in terms of a self-perpetuated process. I conclude with the implications of these findings for improving our understanding of institutional change. Regulatory Logics and Structuration
Institutional logics refer to cognitive maps (Scott, 1995), underlying beliefs about cause and effect relationships and may have normative connotations, such as under what circumstances institutional innovation should occur. Friedland and Alford (1991:244) describe logics as belief systems at play in a social field. In terms of their role in change, a change in logics precedes action for organizational renewal since new organizations are often born from new logics (Scott, 2000:174). Logics thus capture the understanding or collective conception of a problem in that they provide frames of reference in which contemplated actions may be evaluated. A logic is relevant to a field -- an intermediate level of aggregation between organization and society. This includes for example, producers, consumers, regulators, inventors, and anyone else having social ties to these members of the field. With the concept of a logic so defined, a regulatory logic may be understood as the underlying beliefs about what a regulation should do (e.g. protect consumers from fraud) and how it should it. Of particular interest in this study of evolutionary logics is the process by which logics are invoked, reproduced or transmuted as new regulations are put in place. A rule or regulation corresponding to a particular regulatory logic is invoked when it constrains (or enables) certain behaviour, but is also reproduced in the form of social relations between actors. In this respect, Giddens (1984) distinguishes between “structures” that are the rules themselves, “systems” which are reproduced actions between actors and “structuration” which are the conditions governing reproduction or transmutation of social systems. In evolutionary terms, structuration can be understood as a, “gradual maturity and specification of roles, behaviours, and interactions of organizational communities and “is portrayed as increasing the specificity of, and concensus over, resilient logics of action.” (Greenwood et al 2002:59). However, while this received view of institutional isomorphism (DiMaggio, 1983) describes a winnowing out of “unfit” institutions, in a regulated industry where the entry of entrepreneurs and other members of a field is restricted (unlike the case of college text book publishing or savings institutions), logics must evolve over time through adaptations of members of the field itself. These changes are often initiated as a result of a precipitating jolt (Greenwood et al, 2002) or other external shock. In order to understand how logics lie at the nexus of both processes of adaptation and replication of norms and practices, it is useful to consider how two process of organizational evolution, “interaction and replication” which act on “two kinds of entities, ecological and genealogical” (Baum and Singh, 5:1994), may also be applied to the case of institutional logics. Interaction refers to the process by which organizational adaptation occurs in response to environmental changes. Replication, on the other hand is what describes an institution at work – maintaining norms and practices from on generation of organizations to the Interaction and replication can not only be applied to the case of logics, but their ecological and genealogical components used to explain how logics can both promote stability while still enabling change. The genealogical component of a logic serves to replicate rules and norms from one generation (of laws, regulations) to the next. The ecological component on the other hand, interacts with the realities of the environment (e.g. responses to regulatory disasters), thereby moderating the extent to which logics both function as constitutive elements of an institution as we know it, while at the same time creating opportunities for change. Structuration, through its process of transmutation, thus places certain logics on the cusp of replication of existing institutions and constrained adaptation. This is so, because the dual role regulations play in constraining and enabling the development of a new invention. A regulation constrains the development of a new technology by imposing certain conditions (e.g., requirement of randomized clinical trials) but also enables certain inventors to reach the market by, for example granting product approvals, which develop the legitimacy of the product. In the drug industry, new diseases and drugs developed to treat them create a set of regulatory exigencies that often disrupt existing logics. Thus, for example, the scope of regulatory authority of the FDA may be reduced, under a new logic, if it is believed that overly broad regulations prevent consumers from gaining access to certain alternative therapies. Conversely, where regulation serves the interests of developers and regulators alike, the logic will be maintained. The workings of these phenomena are explored in the case of US drug regulation presented below, with an eye to uncovering the process by which a logic may change over time. Research Methods
The drug industry is one in which both regulations and the use of such products has changed significantly over the past few years. In analysing the main laws and functioning of regulatory bodies that were in place over the last 100 years in the USA, my objective was to identify the regulatory logic in place over periods and characterize the pattern of changes in regulatory logic in relation to the types of drugs being offered. In particular, by considering the consistency in laws, establishment of regulatory units and responses of sponsors I sought to distil the principal regulatory logics and understand what motivated a change from one regulatory logic to another. As dominant logic persists through time, I sought to identify the regulatory logic through different eras of the drug industry. Because the logic of any period is embedded in a context of experiences with technologies (e.g. disasters) pressures by lobby groups and the state of technology development, this inductive research used an iterative approach of comparing the emerging theory with the corpus of data and refining theory as new data were examined. Thus, I coded data initially into themes of evolutionary change, then logics, and finally identified different logics. I then refined the categories until they provided stable explanatory power (Miles and Huberman, 1984). The data sources for this preliminary research were academic publications on the history of drug regulation, as well information published on web sites of regulatory agencies and other stakeholders. A database of tracking over 250 events on drug regulation and coding these in various categories (e.g. law, creation of a new regulatory organization) was constructed in order to be able permit identifying different logics as they evolved over different time periods. A summary of the coded categories, showing the regulatory logic of a particular era appears in Table 1. These preliminary findings are to be triangulated with semi-structured interviews, with industry and regulatory officials, to be carried out in the second phase of this research. The Evolution of Drug Regulatory Logics
Following the methods described above, five regulatory periods were identified with respect to their logics, presented below. They are summarized in Table 1, which appears in the Appendix, and are discussed in further detail below. 1) Regulation in the Making: Protecting Consumers From Fraud (1900-1937)

Prior to 1900 drug regulations were scarce and targeted imports of impure commodities. With few consumer protection laws in place, suppliers of industrial chemicals and foodstuffs quickly saw the opportunities for selling products that required little or no testing. The transition from cottage industry to large scale industrialisation, introduced more middlemen, further removing the producer from the complaints of the consumer. Most advertising was directed towards consumers, since any non-narcotic drug could be purchased without a prescription. Indeed, well before the Second World War, lawmakers believed that consumers should be empowered to self-medicate, by providing them with products that were free of impurities such as One of the first drug laws, the 1906 the Pure Food and Drug Act gave the Bureau of Chemistry, a branch of the United States Department of Agriculture, the mandate of providing scientifically-grounded opinions on issues of product adulteration. Several years later in 1931, the Food and Drug Administration emerged as the regulatory branch of the Department of Chemistry. In many respects, the reorganization of the Bureau of Chemistry is indicative of a major effort of battling consumer fraud in the form of “misbranding” – using misleading product claims and advertising. Even so, the FDA of this era is more of a watchdog organization that anything else because of its limited resources and its lack of authority to confiscate potentially harmful products or prevent them from being sold. The regulatory logic during this period of infancy, is thus best characterized as policing against fraud and unfair trade practices using scientific expertise. The FDA has little authority because most dangers are perceived to be the result of intentions to dupe consumers. This “purity” logic was, however, upset when it was confronted with the idea that “pure” poisons and mysterious potions such as “snake oils” could be lethal. 2) Regulation of an Emerging Research-Based Industry: Premarket Approval (1938-1960)

Following the gradual industrialisation of consumer product manufacturing, the fledgling drug industry followed a pattern of “regulation by disaster.” As a result of poisonings from ingestion of a product labelled as Elixir of Sulfanilamide, the 1938 Food, Drug and Cosmetics (FD&C) Act required ingredient listings for food preparations, drugs and cosmetics. In the ensuing lawsuit launched by families of the victims of sulphanilamide, it was revealed that its manufacturer, The Massengil Company, never conducted tests to assess the safety of the product because they were not required by law. The 1938 FD&C Act was therefore in large part a response to these regulatory shortcomings as it was the first law that required companies to conduct tests of safety and provide instructions for use of the product, in order to obtain approval. The FDA still however, carried the burden of showing that a product was “usafe” in order for it to In the period following the 1938 legislation, the drug industry grew considerably, in what many consider as the birth of the “ethical drug” (i.e., advertised only to doctors2) industry as a result of the need for companies to invest in scientific research on safety. Thus, as Hilts The conditions for the development of those drugs had been coalescing. The science had matured, beginning with the germ theory and then the testing of drugs against the germs. The patent laws had changed to make possible the profitable control of a drug by the company that owned it. The industry, which previously had no real interest in research and medicine, began to see things differently with the advent of sulfa drugs and when the 1938 law forced them to test their drugs. They had to create departments Another significant development of the era was the Durham-Humphrey Law of 1951 which explicitly introduced the distinction between prescription and OTC drugs.3 However, since several dispositions of the 1938 FD&C Act required the manufacturers to make information available to consumers if it were to be sold as an OTC drug, prior to the 1951 law, it was drug manufacturers, and not the FDA that determined whether their product was to be a prescription drug. Simply put, by making product information on the package insert unintelligible to consumers (i.e., destined to doctors), it had to be sold “by prescription only” (Temin, 1979). Thus, as a lawsuit involving prescription antibiotic, Chloramphenicol, illustrates, even if a consumer were to misuse the product (e.g. by overdose or contraindication) courts placed responsibility for adverse consequences squarely on the doctors, pharmacists and manufacturers The field composed of drug companies, regulators and consumers had thus converged about a regulatory logic of premarket approval in which only drugs tested for safety could be approved by the FDA and certain drugs could only be obtained by prescription. This regulatory logic supported the growth of an emerging industry because the restricted access to prescription drugs, while on the one hand, prevented self-medication, also created a valuable entry barrier for competitors. At the same time, stricter regulation enabled the FDA to fulfill its mandate of protecting the public from hazardous products, even though the rapidly emerging drug industry 2 The term “ethical” is due to the 1847 code of ethics of the American Medical Association, which excluded advertising to the public as ethical practice. See Temin (1980:3). 3 OTC drug: a drug sold “over the counter”, that is without prescription. began to introduce new drugs which created new risks. The reasoning behind this, was of course that the state had to intervene, even at the cost of suppressing consumer choice, because consumers were unlikely to be able to have the requisite knowledge to make informed choices. 3) The FDA as a Gatekeeper of Clinically-Proven Drugs: The Kefauver-Harris
Amendments (1961-1979)
In spite of its greater emphasis over control over products reaching the market, the most important amendments to US drug regulation followed in large part, as a result of a second regulatory disaster: the thalidomide experience. Thalidomide, a drug prescribed to pregnant women for morning sickness in the late 1950’s to early 60’s. In 1960 Richardson-Merrell applied to commercialize the drug in the US under the trade name Kevodon, but it was withdrawn from the market after it was linked to serious birth defects for which no precommercialization tests had Still operating largely under a directive of applying scientific reasoning to identify potentially toxic concoctions, the FDA knew little about the conditions under which clinical trials were conducted, nor if patients were adequately informed of the risks of participating in such trials. Following the thalidomide disaster, the 1962 Kefauver-Harris Amendment to the FD&C Act sought to remedy this situation by requiring that drug companies conduct controlled clinical trials (“randomized clinical trials”) to demonstrate the efficacy of the drug in addition to its safety. More importantly, the standard of “substantial proof” and “adequate and well-controlled scientific experiments” became the standards by which ethical drugs were approved. As Hilts […] many of the essential components of a complete scientific regulatory agency had been assembled. First, and most important, the agency could review products for safety and effectiveness before they went to market. A scientific base had been built – it required by law « well-controlled scientific studies » as the absolute standard. It had been placed squarely among agencies of the public health whose job was not to serve industry but to serve citizens. The agency was thoroughly professional, and was open to the public. The model of the controlled clinical trial instituted a rigorous but transparent drug approval process established the role of the FDA gatekeeper of new drugs. This regulatory logic allowed both the drug industry to expand considerably, shifting its advertising from the consumer to doctors, who were visited by sales representatives (“detail men”). The more demanding role of approval also enabled the FDA to acquire greater authority in order to fulfill its mandate of public service. As a testament to the latter, in 1988 the FDA became an agency of the Department of Health and Human Services. However, because the logic of “clinically proven” efficacy lengthened approval times and increased the cost of clinical (Phase III) testing, it did not remain 4) Ensuring Accessibility: Treatment Investigational New Drugs in the Era of AIDS (1980-
1989)
As a matter of public policy, the consequences of increased development and approval times became most apparent in during the early 1980’s AIDS when appeared in the USA. As late as 1984, drug companies estimated that it was a less than fair gamble because it was never believed that the disease would be widespread. Several patient advocacy groups such as ACT UP (“AIDS Coalition to Unleash Power”) maintained that, as a result of the FDA’s review process which required extensive clinical testing, potentially useful experimental (“investigational”) drugs not reaching patients who had no other viable treatment options. Although the FDA policies did, in exceptional cases, allow investigational drugs to be administered to terminally-ill (e.g., cancer) patients, the AIDS crisis resulted in further measures to apply these exceptions to as many as 45 000 patients in order to provide them access to new, so-called, “Treatment Investigational New Drugs.” It was also during this time, other new policies of “parallel track approval” which aimed to speed up the review process by enabling sponsors to submit clinical data as soon as it became available (FDA, These policy changes were in response to the criticism that the FDA’s rigourous approval policy was no longer able to adequately respond to modern day needs. As the title suggests, the General Accounting Office’s report, “FDA Drug Approval – A Lengthy Process that Delays the Availability of Drugs” (GAO, 1980) the AIDS crisis raised awareness of the need to weigh the costs of preventing potentially useful drugs from reaching terminally-ill patients against its benefits. This shift in regulatory logic, that of a gatekeeper of new technologies, to one in which it served the public by ensuring rapid access to new drugs was further reinforced from the support of two important stakeholders within the field: drug companies and AIDS patients. Treatment Investigational New Drugs enabled companies to speed up their development process while at the same time, appeasing the demand by AIDS patients for the right to make their own drug consumption decisions, given their fate. But while changes to drug approval and enforcement policies increased accessibility to experimental drugs, AIDS activists had eventually appreciated that the needs to balance access to new drugs against safety was a delicate one. Numerous “cures” for AIDS had begun to appear, raising concern (among AIDS activists and other consumer advocacy groups) that that it was nevertheless necessary for the FDA to be vigilant against fraudulent health claims and potentially harmful products. Most of these products were not however new, drugs, but instead natural health products in the form of supplements, herbs and vitamins. 5) Redefining the Authority of the FDA: The Emergence of Regulated Natural Health
Products (NHPs) (1990-2003)

The regulatory logic developed out of necessity during the AIDS crisis emphasized the importance of accessibility to experimental drugs and introduced the idea that consumers should have a greater rights in making informed health care decisions. However, in order to be able to do so, they need to be able to have access to information about such products. In 1984, the National Cancer Institute endorsed the benefits of a high-fibre foods such as Kellog’s cereals, while the National Academy of Sciences published an opinion on the role of diet on chronic disease such as cancer and heart disease. The 1990 Nutrition Labelling and Education Act (an amendment to the Food, Drug and Cosmetics Act) moreover permitted all manufacturers to make “generic” health claims such as the relationship between the consumption of certain foods and vitamins and health conditions like heart disease, provided that there was “significant scientific agreement” about the validity of such claims. These were important developments because under the existing Food, Drug and Cosmetics Act, products (with the exception of vitamins) making health claims4 were regulated as medicines, and therefore had to substantiated by controlled clinical trials. The FDA reasoned that because there had been a lack of substantial agreement (e.g., lack of information resulting from clinical trials) it was in the best interest of the public to ban such claims as opposed to allowing sponsors to make them with a disclosure such as “these statements have not been evaluated by the FDA.” This policy was later challenged in what is perhaps the most significant legal challenge In the 1990’s Durk Pearson and Sandy Shaw, marketers of supplements and vitamins applied to have four health claims appearing on their product labels. The claims linked the consumption of certain substances such as vitamins and fibre to health outcomes such as a reduced risk of certain kinds of cancers. The FDA rejected such claims on the grounds that it violates Food, Drug and Cosmetics Act prohibiting health claims without clinical studies (Emord, 2000). The US Court of Appeals for the District of Columbia, overturning the lower court’s finding in favour of the FDA, effectively invalidated these regulations, ruling that they violate the petitioner’s First Amendment right to lawful and non-misleading speech, and that it had not adequately defined its own standard of “significant scientific agreement” (Arent Fox, 2005). In sum, Pearson v. Shalala5 established that disclosure of information explaining how a claim could be potentially misleading is preferable to authorizing a government agency to ban it. In the same vein, Congress introduced The Dietary Supplement and Health Education Act (DHSEA) introduced in 1994, an amendment to the Food Drug and Cosmetics Act, which explicitly enables health claims to be made such as those described above, without sponsors having to undertake clinical trials. It thus, effectively established a new category of regulated 4 A “health claim” is defined as any claim made on the label or labelling of food, including a dietary supplement, that expressly or by implication characterizes the relationship of any substance to a disease or health related condition. 21 C.F.R. § 101.14(a)(1). Such claims are also known as “structure-function” claims. It is moreover important to note that in the USA natural health products, such as vitamins and supplements are classified as food products, which by definition cannot treat or cure any disease. For this reason, specific legislation authorizing health claims on supplement bottles or other natural health product 5 Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), reh'g, en banc, denied, 172 F.3d 72 (D.C. Cir. 1999). Many commentators view the DHSEA “as clear acknowledgment that adult individuals ought to be trusted to make their own decisions.” (Frank, 2001). Further evidence of this are dispositions of the Food and Drug Agency Modernization Act (FDAMA), in which allows manufacturers to make therapeutic claims even in the absence of FDA regulations, provided that the claims can be substantiated by statements by a government-based scientific agency such as the NIH, the CDC and the NAS. As reported in one stakeholder website, « Changing the role of government from one as gatekeeper to one as referee is a far more constitutional way of regulating commercial speech, which also tends to be more beneficial to public health.” (Frank, 2001). The logic of the final period thus recognizes the potential for FDA regulation to create undesirable entry barriers for suppliers of valuable therapeutic substitutes as well as the virtues of increased accessibility to non-misleading information directed towards the consumer. In this regard, it advocates a return to right to self-medication (at least for some categories of health care products) – something that had been taken away from the consumer in the 1938 FD&C Act, which advocated greater responsibilities for physicians and pharmacists. Discussion
Although the history of drug regulation is often described in terms of landmark “disasters” like sulphanilamide, thalidomide and AIDS, the foregoing presentation suggests why it may be better understood as an evolution in regulatory logics. Each of the five regulatory periods instituted logics served specific goals, as summarized in Table 1: maintaining purity; requiring premarket authorization; providing clinically-proven drugs; improving accessibility to potentially useful drugs; empowering consumers with more complete information. Through a process of structuration, each logic also created conditions that made it ripe for changes. For example, the 1906 Pure Foods and Drugs Act, initiated the development of a pharmaceutical industry because it introduced “Pure” drugs, while maintaining easy access (without prescriptions) to such products. However, because growth of the industry brought pure but potentially lethal drugs (e.g. sulphanilamide) it developed the desirability of a logic emphasizing premarket authorization. Similarly, just as the logic of premarket authorization further fostered the development of the fledgling drug industry, it also developed the need for greater clinically-proven safe and effective drugs. The “clinically-approved drug” model defined the drug industry as a research-intensive one, but also resulted in consumer backlash when it could not deliver potentially useful drugs to terminally ill patients. Finally, as a result of clinical model’s the lengthy approval process and the drug industry’s inability to offer cures for many systemic diseases like AIDS, natural health products began to gain popularity. Courts also appreciated the virtues of maintaining opportunities for consumers choose their own treatments and that the authority granted to the FDA as part of the Kefauver-Harris amendments should not Structuration is seen in each of these examples by the fact that exercising the regulatory framework (e.g., applying for approval to commercialize a new drug) also creates conditions that end up mandating its reform. Social relationships between members of the field are reformed as each “disaster” redefines the significance of the legal regime and desirability of the regulatory logic in place. To see this, consider that, the slow approval of a number investigational AIDS drugs raised awareness of the extent to which the regulatory system constrained consumer choice. The ensuing redefinition of the relationship between developers of natural health products (NHPs) and the FDA put in place a new category of NHPs that redefined the authority the FDA had over the claims made and information provided by manufacturers on product labels. For these reasons, events such as AIDS and thalidomide are best regarded as precipitating jolts that trigger an evolution of regulatory logics. A jolt will be significant and effective if it develops the shortcomings of the regulatory logic in place and need not necessarily be externally sourced. Sulfanilamide, chloramphenicol and thalidomide were all endogenously generated jolts because they were all created by drug firms operating within the field governed by the prevailing Finally, the foregoing model of evolutionary change in regulatory logics attributes institutional change to endogenously-driven forces. For each of the five regulatory logics I identified destabilizing conditions, some of which were accompanied by jolts. Thus for example, in more open fields where a variety of institutional logics may prevail until a “shakeout” occurs, a these forces may create proto-institutions (Lawrence et al, 2002), the precursors to institutional reform. In highly regulated environments were entry is much more difficult, evolution rather than competition of logics is likely to occur. Moreover, the evolutionary pattern of change suggests that later-period logics will incorporate many of the experiences of previous logics in a cumulative fashion. Thus, even though recent laws such as the DSHEA strive to enable consumers to make their own self-medication choices for NHPs, as well as provide more consumer information on package inserts, there is no indication of regulatory changes that would effectively do away with “by prescription only” drugs. While I have portrayed shifts in institutional logics as being governed by endogenously- generated macro forces of change, initiated by jolts, a more fine-grained analysis is necessary to reveal the micro-level dynamics that motivate shifts in institutional logics. For example, even though the drug industry remains a relatively closed industry, the field has in reality been more open than this, as a result of changes in the way health care services are delivered, demographic changes, improved hygiene and income levels, all of which have increased the demand in the developed nations for drugs treating degenerative disease. A variety of health care practitioners, including those specializing in “complementary and alternative medicine” now supply this demand and are the target of regulation by governments and professional orders. Even so, the underlying proposition that a shift in institutional logics can be endogenously-generated, is likely to be useful to the more recent work investigating the process by which institutions are not merely replicated but mutated across generations of actors and technology. References
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Period Main
Regulatory Logic
Technology / Industry
regulatory
innovation/
practices
organization, Jolt
1906 Pure Food and Police fraudulent claims Opium, arsenic, Concoctions, based on folk based on scientific know how cocaine, alcohol, remedies . Bureau of Cortisone (1948) infectives based on germ Harris Amendment development of drug industry therapeutic areas infectives. Approved (cardiovascular, claims can be obtained by anovulant “Pill” scale R&D results in Fast-track legislation Serve the public through accessibility to experimental anti-retrovirals Investigational New drugs. Individuals should be (e.g. AZT) AZT many valuable drugs may NHP regulation (e.g. FDA should not be the sole therapeutic value of necessarily evaluated by FDA. Regulation must help St. Johns Wort

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