Laws and Ethical Issues Related to Flu Research

The Secretary of the Department of Health and Human Services has responsibility for preventing the introduction, transmission, and spread of communicable diseases in the United States. In IPR studies patent applications covering the virus itself, vaccines, treatment and diagnostics. Clinical studies of influenza involves development of drugs for the treatment  and/or prophylaxis of illness caused by influenz a viruses A and B, including both seasonal and  pandemic varieties. Sponsors considering development of antiviral drugs for the treatment or prophylaxis of disease with novel influenza strains, or in a pandemic influenza setting, are encouraged to consult this guidance and to communicate with the FDA through the pre-investigational new drug application (pre-IND) consultation program and frequently throughout drug development.

The influenza pandemic provides an opportunity for policymakers to reconsider the benefits of mandating influenza vaccination for health care workers, including building public trust, enhancing patient safety, and strengthening the health care workforce. Health care organizations have enacted a variety of vaccination policies and interventions to guard against the known hazards of nosocomial influenza transmission, including longer patient stays, absenteeism, interruptions in health care delivery, and inpatient death. Health care standards may need to be modified to respond to the public health threat and to the imbalance between the care that is needed and the resources that are available.

  • IPR studies in influenza research
  • IPR studies in influenza vaccines, therapeutics and diagnostics
  • Clinical trials in influenza treatment
  • Ethical issues in pandemic influenza planning
  • Influenza research and animal models

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