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Expanding Access to Investigational Therapies for HIV Infection and AIDS (1991) / Chapter Skim
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5 DRUG INNOVATION AND THE PHARMACEUTICAL INDUSTRY
Pages 45-52

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From page 45...
... The effects of adverse incentives created by expanded access would be evident first in smaller companies, particularly the fledgling biotechnology firms. These companies have the expertise to make major strides in the new field of rational drug design, but they may not have the resources to sustain premarket drug distribution.
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From page 46...
... A spokesman for Bristol-Myers Squibb notes that time and energy nvested in the expanded access protocols for ddI have caused delays in market approval for two other drugs, both antibiotics in the late stages of clinical development. He says that the opportunity cost associated with these delays-the nonrecoverable loss of future sates resulting from reductions in useful patent life-might emerge as the largest single cost factor of the expanded access effort.
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From page 47...
... Our Medical Department gathered and organized the information necessary to manage the expanded access project and worked with our Research Division and the FDA to develop and process the ddI protocols. Our Operations Group had the task of finding a building to house the information center and equipping it.
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From page 48...
... government scientists, and AIDS patients and their representatives informed about any new developments in the various clinical trials and expanded access protocols. Drug Costs The drug itself is a major cost factor.
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From page 49...
... Patient advocates and some scientists involved in the drug development process are uncomfortable with this proposal. They say that most administrative costs associated with expanded access could be recaptured when a candidate drug receives market approval; for example, physician and patient education programs and drug distribution mechanisms in the parallel track could become the core of the commercial marketing program.
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From page 50...
... In a traditional drug trial, the pharmaceutical manufacturer depends on skilled clinical investigators to provide the highest level of medical care. These clinical researchers have access to sophisticated technology to help them monitor patients and to recognize the onset of adverse reactions.
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From page 51...
... · A final mechanism would be to amend existing FDA regulations to make it possible for pharmaceutical manufacturers to negotiate directly with prospective subjects in clinical trials, who would then waive their right to sue. The FDA usually does not permit this type of one-on-one negotiation, but an industry lawyer suggests that it might be appropriate in the context of expanded access programs for AIDS drugs because patients and their physicians assume greater responsibility for the decision to proceed with treatment than do participants in traditional clinical trials.
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Key Terms

  • parallel track
  • clinical trials
  • access programs
  • treatment ind
  • access protocols

  • aids drugs
  • patient eligibility
  • access program
  • market approval
  • pharmaceutical manufacturers

  • product liability
  • pharmaceutical companies
  • access protocol
  • direct costs
  • fda approval

  • clinical investigators
  • drug costs
  • drug candidates
  • drug development
  • drug distribution

  • liability concerns
  • expenses associated
  • protocol knowing
  • government scientists
  • risk associated

  • provide administrative
  • wide distribution
  • prospective subjects
  • late stages
  • court recently


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