A major activity occupying the U.S. Food and Drug Administration for several years has been a rewrite of the FDA's IND and NDA regulations which govern the clinical testing of investigational new drugs and the process for subsequent market approval for those drug entities. In March of 1987, the FDA "reproposed" that portion of the 1983 IND rewrite dealing with the "treatment use" of investigational new drugs during the clinical testing phases of new drug development or during the period between the completion of clinical testing and NDA approval. The Treatment IND reproposal resulted in substantial controversy immediately following its publication in the Federal Register. This article compares the key features of the Treatment IND regulations as reproposed with those of the Final Rule and summarizes the major points of contention among the various interest groups affected. With its new Treatment IND regulations, the FDA appears to have placed itself squarely between competing interests and public policy considerations. The essential purpose and role of the FDA is to determine the inherent safety and effectiveness of new therapeutic medications. Debate on the Treatment IND regulations has raised a number of questions as to the regulations' own safety and efficacy in achieving that objective. It is likely the Treatment IND implementation will engender as much controversy as the regulations as originally reproposed.
Our epigraphs issue from two very different sources. The first is an emphatic moment in the two-part, interwar-era tome on Strauss by Richard Specht, whose pseudo-philosophical project to revalue the composer aspires to transcend its life-and-works skeleton. And the second is spoken—or urgently sputtered out, rather—by Billy Kwan, the Australian-Chinese dwarf-photographer who feverishly compiles dossiers on Westerners and non-Westerners alike in his Jakarta bungalow against the backdrop of the 1965 communist coup. (Billy’s words have, of course, been passed down from the Gospel of Luke, Tolstoy, and Lenin, among others.) There are meaningful intersections, indeed, between Specht and Billy as concerns Richard Strauss. Strauss is the unambiguous focus of Specht’s study; “we” (inheritors of Specht’s “now”) are bequeathed with a future perspective that ostensibly allows “us” to grasp the composer, giving him (and Specht, too) validation at long last. Strauss’s famous presence on The Year of Living Dangerously soundtrack is also central, but requires a bit more unpacking. Via Kiri Te Kanawa and the London Symphony, we first hear Strauss’s “Beim Schlafengehen” from the Vier letzte Lieder when Billy is hosting Australian journalist Guy Hamilton at his bungalow. While filing dossiers, Billy turns up the stereo, saying, “Listen to this, Guy.” Guy, reclining in a chair, smoking, and staring at Billy’s photo-plastered wall, instantly focuses on a picture of Jill Bryant, an officer at the British Embassy who both men love. Guy’s gaze at Jill is locked by the strains of Te Kanawa’s singing “Und die Seele unbewacht . . .” Strauss’s song—and obviously Te Kanawa’s voice—is a source of deep inspiration for Billy: he assumes the role of the Marschallin (I know: different Strauss, but a role that Te Kanawa also envoiced many times), offering Guy the use of his bungalow while he is away as a self-sacrificing green light to Guy and Jill’s nascent affair. (The intriguing Billy, as portrayed en travesti—and yellow face, too— by actress Linda Hunt could be read as a mongrel Marschallin–Octavian.) That Billy actually spies on Guy and Jill to gather material evidence for their dossiers communicates that he is much more complicated than the Marschallin, and that the stakes are different in 1965 Jakarta than in Maria Theresa’s Vienna. It also reminds us that
During the course of the Kefauver hearings, some testimony was given that presaged some important changes in the relationships between the pharmaceutical industry and organized pharmacy and individual pharmacists. The special nature of the drug marketplace–with the pharmacist as retailer i the channel of distribution–is discussed, along with the American Pharmaceutical Association's part in the Congressional hearings. Again, significant portions of the testimony in the various hearings are reproduced, along discussion and analysis.
SUMMARYThis article discusses some of the social and organizational forces acting on pharmacy educators. It argues that these forces make the presentation of a balanced, in-depth discussion of the pharmaceutical industry extremely difficult. Evidence that the popular culture has demonized pharmaceutical executives to the point of caricature is presented, and the point is offered that this sort of distortion has found its way into the academy. Sources of potential bias against the industry are discussed, as well as the various sins of omission and commission to which pharmacy faculty may be prone which contribute to the negative image of a life-saving industry, as well as suggestions for positive action.
SUMMARYThis article looks at the behaviors of pharmacy and the pharmaceutical industry that are not appreciated by the other party. These are natural, to-be-expected events that are part of each organization's striving to be successful regarding sales growth and profitability. Several examples are cited from both perspectives, and the article concludes that perhaps knowledge about the impact of our decisions and actions upon others might, at least in some small way, contribute to developing more distribution-channel-friendly practices. Both entities can be expected to be around for the foreseeable future, doing what is needed to create shareholder value, but knowledge of the halo effect of their actions might smooth a needed and necessary relationship.
Some of the most remarkable testimony in the course of the varioius Congressional hearings came from a former executive in the pharmaceutical industry, George S. Squibb. Portions o his testimony are reproduced and discussed in this section.
SUMMARYThis paper discusses how the rift between industry and the profession has hurt both, leading to the commoditization of some drugs and services. In an effort to close the rift, a working document was developed by state pharmacy associations and PhRMA titled “Guiding Principles for a Pharmacy Benefit: A Call for Pharmacy Provider Services and Access to Pharmaceuticals.” The principles provide mutual recognition of the roles of both industry and the profession and an agreement around which alliances can be developed in response to state legislation that does not recognize the role pharmacists or innovative pharmaceuticals play in improving patient outcomes.
SUMMARYThis paper describes the mutual origins and shared history of pharmacy and the pharmaceutical industry. Pharmacists had major roles in the origin of today's pharmaceutical companies, and many industry professionals have held leadership roles in pharmacy associations and helped build the profession. As the relationship evolved, published accounts describe conflict between the two parties, often over their respective responsibilities to stakeholders. It can be argued, however, that the conflict often revolves around competing payment incentives and artifacts of a system of health care delivery and financing recognized as inefficient. Instead, pharmacy and industry should be fighting the real enemy, disease. Efforts should focus on innovating care and aligning payment and recognition incentives with new prescription medicines and pharmacist services.
SUMMARYThe independent nature of hospital pharmacy practice makes the pharmacist a potent industry adversary in drug use. The rift between hospital pharmacists and the pharmaceutical industry may be smaller than in other areas of pharmacy due to the data-driven, guideline-based nature of care, which limits the influence of marketing activities. The tension between the pharmaceutical industry and hospital pharmacy resulting from this independence is a key component of the hospital pharmacist's professional ethic. To seek a full reconciliation between industry and hospital pharmacists might be productive for industry, but it would certainly have long-term negative consequences for pharmacy and pharmacists.KEYWORDS: Hospital pharmacypharmaceutical industryformulary
SUMMARYNational pharmacy associations have worked with pharmaceutical manufacturers on a variety of programs and projects across the decades. Resources provided by the industry serve to support education, public relations programs, and special projects aimed at pharmacists and the general public. A variety of forces, including economic and political factors, have influenced how these collaborations are designed and the types of projects undertaken. Over time, the relationships and projects have changed from an “industry relations” strategy to more of a “return on investment” strategy. The industry and pharmacy organizations have much to gain by working together to help those who don't understand the value of well-designed and competently managed drug treatment plans to realize that medications are more than just a commodity to be acquired at the lowest possible price.
SUMMARYMarketing theory indicates that there is always conflict in channels of distribution. The pharmaceutical industry and the profession of pharmacy have a long history of conflict. It is manifested primarily as a battle over control of prescribing and dispensing decisions. Over time, the profession and industry have opposed each other on the issues of generic interchange, therapeutic substitution, and collaborative drug therapy management. While conflict between channel members will always be present, it can be minimized by a focus on shared goals. A greater commitment by each group to focus on patients–by promoting adherence and the use of cost-effective products, for example–could go far toward minimizing the level of conflict.
