From there, marketing is conducted to physicians directly, necessitating a relatively large sales force. The presence of competing treatments necessitates significant investment marketing, compounded by the impact of the need to recoup the sunk costs associated with product development. In addition, marketing in the biotechnology industry is strictly regulated by the Food and Drug Administration. The FDA exerts tight control over marketing -- a firm is only allowed to promote products for approved uses. Off-label marketing -- defined as marketing a product for uses not approved by the FDA -- is prohibited and firms found guilty can be subject to significant fines.
An example, of the strong regulatory influence on marketing can be found in the approval that United received in July for Tyvaso. The product, already delayed multiple times by the FDA, was finally granted approval. With this approval came requirements known as post-marketing commitments. These included long-term studies on specific uses, usability analysis and the collection of pharmacokinetic data (United Therapeutics, 2009).
Operating within the FDA's constraints, United has developed marketing strategies that it feels will increase the total market size for its products. The marketing plan for Remodulin is built around building awareness of PAH, and simultaneously building awareness for United's PAH products. The marketing team for this product is growing, from 65 employees in 2007 to 80 in 2008. The sales teams are split into two groups -- inside and outside sales. The former focuses on accounts that have prescribed Remodulin in the past while the latter is focused on practices that are not yet accounts (2008 United Therapeutics Form 10-K, 8).
United also utilizes marketing partnerships to help bring its products to market. Specialty pharmaceutical dealers have competencies in a wide range of areas that pertain to marketing issues in the industry. These include patient care, administration of therapies, distribution and obtaining reimbursement from insurance companies. In Canada, distribution is conducted through a wholly-owned subsidiary. Internationally, United utilizes exclusive distribution agreements and has a wide range of geographic distribution (2008 United Therapeutics Form 10-K).
United Therapeutics has steadily increased its marketing capabilities over the past few years. This has come in response to having an increasing number of products on the market. The firm's use of strategic partners and specialist distributors helps to broaden the scope of the market for its products. It also flattens the learning curve for the young company with respect to the full range of marketing and regulatory issues to which United is subject. Furthermore, such alliances help the firm to focus its internal marketing capabilities on the domestic market.
Ethical Considerations
As with other biotechnology firms, United Therapeutics is subject to ethical scrutiny on two main fronts. One is with respect to the marketing of its products and the other is with respect to its corporate governance practices.
There are several ethical considerations with respect to marketing of pharmaceuticals. The marketing of such products is strictly controlled by the Food and Drug Administration. When the FDA approves a product, it does so only in the context of specific uses and scenarios. One of the most important areas of marketing ethics in biotech is with respect to the so-called "off-label" uses. Firms are not allowed to promote products for purposes not approved by the FDA. However, there are instances when such uses may be beneficial to a patient. It is at the physician's discretion that such uses are prescribed. United has policies in place (Policy XII) to eliminate marketing of its products that contravene FDA regulations. United also has a Compliance Committee and Compliance Officer to enforce its house policies and provide guidance to marketing staff on ethical issues (United Therapeutics, 2009). The company also adheres to the guidelines set forth by the American Medical Association (AMA), the California Compliance Law (CCP), the Office of the Inspector General (OIG) and the Pharmaceutical Research and Manufacturers Association (PhRMA) (Ibid).
Another area of ethical consideration is with respect to clinical trials. There are several ethical issues in randomized clinical trials (RCTs). One is the use of placebo control subjects. These subjects may enroll in a trial in part because they wish to receive new therapy that can help them with their condition. If these subjects then receive a placebo instead, they are not receiving the benefit of the trial that other participants are receiving (Halpern, Doyle & Kawut, 2008).
Another ethical concern in trials is with respect to the patient's motives for joining a trial. While some do so for the treatment they may receive, or to help advance the cause of research,...
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