B. HIVIAIDS Drugs: Development and Distribution HIV/AIDS drugs, such as AZT and various protease inhibitors, are the focus of a particularly intense research and development program within the pharmaceutical industry. In 1991 sixty-four different firms were working on developing eighty-eight different HIV/AIDS drugs. PhRMA describes the development of these drugs as an extremely expensive process, with the pharmaceutical industry investing approximately $19 billion a year in research and development. 9 This current level of investment is the result of a continual and remarkable
increase in research and development expenditures which has taken place throughout the pharmaceutical industry over the last twenty years, with the amount spent on research and development increasing from $2 billion in 1980, to $8.2 billion in 1990, to its present level of $19 billion.2° The cost of developing each new drug is itself extremely expensive, with a 1987 estimate of $231 million.2' The pharmaceutical industry attributes the high cost of individual drug development to the high-risk research and development process required to successfully bring a drug to market. Only one out of every four thousand drugs investigated and developed eventually wins government approval and can be marketed. The cost of each drug that reaches the market thus includes not only the direct cost spent on developing that particular drug, but also includes the cost of researching the other 3,999 drugs that had to be investigated to find that one marketable drug.3 The 1962 amendments to the federal Food, Drug, and Cosmetic Act,24 which created a rigorous approval process for new drugs, are another source of expense in the development of HIV/AIDS drugs. 5 Approval of a new drug requires successful completion of multiple clinical trials that demonstrate safety and efficacy, a process that can take 26ten to twelve years and cost more than $231 million. Just as the true cost of researching and developing successful new drugs includes the cost of researching drugs that ultimately prove unmarketable, the true cost of satisfying the approval process requirements for a successful new drug includes the cost of putting the many drugs that ultimately fail to win approval through the process as well.27 In 1987, the basic approval process yielded to the HIV/AIDS epidemic's severity with the creation of a new, accelerated approval process that allows drugs that make strong showings in the early stages of the approval process to be made available to people outside the clinical trials at a much earlier point in the approval process than was previously permitted. 2 8 The United States government has further facilitated the development of HIV/AIDS drugs by conducting some of the initial testing of these drugs itself and by providing resources to support clinical trials.29 Pharmaceutical companies have been able to successfully obtain patents for HIV/AIDS drugs that they have developed and have been