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. OSHI also provides information about the FDA drug approval process and clinical trials,
and administers MedWatch, the FDA Safety Information and Adverse Event Reporting Program. OSHI
major functions include:
•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
•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
•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.
NCPIE encourages healthcare professionals and community groups to foster patient–professional communication about medicines. However, NCPIE does not supervise or endorse the activities of any group or professional. Discussion and action concerning medicines are solely the responsibility of the patient and their healthcare professionals, and not NCPIE.
Please consult a licensed health care professional with questions or concerns about your medication and/or condition.