Office of Special Health Issues

Mission Statement

The Office of Special Health Issues works with patients, patient advocates, and health professional organizations to encourage and support their active participation in the forming of the Food and Drug Administration's (FDA) regulatory policy. The staff is familiar with the concerns confronting patients and families dealing with a life-threatening illness.

We serve the public by answering their questions and concerns related to HIV/AIDS, cancer, and other Special Health Issues.

We also provide information about the FDA drug approval process and clinical trials.

Some of our responsibilities include:

• Serving as a channel through which patient and health care professional issues and viewpoints can be brought to the attention of FDA medical and regulatory staff
• Ensuring a comprehensive and timely response to individuals with questions and concerns related to life-threatening diseases and other special health issues
• Participating in the development of national policies and practices concerning HIV/AIDS, Cancer, and issues related to Special Populations, such as racial/ethnic groups, pediatrics, and gender specific concerns
• Collaborating with health professional organizations to pursue mutual interests and initiatives around medical product safety and communication
• Providing information about the FDA drug approval process and clinical trials
• Providing FDA representation at scientific and policy meetings related to life-threatening diseases and other special health concerns