Office of Special Health Issues

The Office of Special Health Issues (OSHI) is a liaison between the Food and Drug Administration (FDA) and patients, patient advocates, and health professional organizations. The staff encourages and supports active participation of these groups in forming FDA regulatory policy.

OSHI responds to inquiries and concerns related to HIV/AIDS, cancer, and other special health issues. The staff is familiar with the concerns confronting patients and families dealing with a life-threatening illness.

We also provide information about the FDA drug approval process and clinical trials, and administer MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

Major Functions:

• Advises the Commissioner and other key FDA officials on matters related to patients, patient advocacy, and health professional issues and concerns; serious and life-threatening diseases; minority health; and other special health issues
• Serves as a liaison between FDA and health professional and patient advocacy organizations to solve problems and address concerns these groups have with agency policies and programs related to human medical product development and safety.  
• Assists in the planning, administration, development, and evaluation of FDA policies related to patient advocacy and health professional organizations, serious and life-threatening diseases, and other special health issues
• Provides internal coordination on FDA activities related to patient advocacy and health professional organizations, serious and life-threatening diseases, and other special health issues 
• Serves as a focal point to coordinate contacts and activities between FDA and other Federal agencies to ensure effective coordination and communication regarding issues related to serious and life-threatening diseases and other special health issues
• Coordinates and implements policies, programs, and initiatives related to MedWatch including the MedWatch web site, E-list, RSS feed, and Twitter account
• Conducts liaison activities and education with health professionals, patients and the public to facilitate the reporting of serious harm and injury associated with the use of human medical products.
• Prepares, reviews, updates, and disseminates medical product safety alerts and periodic safety labeling change summaries to patients, patient advocates, and health professionals.
• Informs patients, patient advocates and health professional organizations of upcoming public meetings, policy issues, and proposed rules, so that they are aware of important issues and informed of opportunities to comment.
• Assures that patient points of view are given a voice in drug development and policy issues that affect patient communities, through the patient representative and patient consultant programs.