ABSTRACT

In the United States, the biopharmaceutical industry has multiple players and a complex payment system. Although the end consumers are patients, they are neither direct payers to pharmaceutical companies nor direct receivers of potential drug rebates. Further, patients have no direct drug purchasing power, although they can communicate preferences with their physicians who may or may not prescribe their preferred drugs. This chapter illustrates how in the early years of the Food and Drug Administration the focus was on safety of new drug candidates; however, later, the agency actively encouraged the development of innovative treatments for AIDS patients. The Merck example illustrates that the need for pharmaceutical companies to remember their ultimate goal is not only to make profit but also to help provide beneficial therapeutics to the public. The Vioxx® situation emphasizes the importance of pharmaceutical companies acting in the best interest of the public and patients, not just their shareholders.