- Advises the Commissioner and other key FDA officials on matters related to patients, patient advocacy, health professionals, consumers, state and federal activities and industry issues.
- Assists in the planning, administration, development, and evaluation of FDA policies related to patient advocacy and health professional organizations, consumers, states, industry on serious and life-threatening issues.
- Serves as a Liaison between FDA and stakeholder organizations to educate various constituents on FDA related issues and activities.
- Provides internal coordination on FDA activities related to patient advocacy, health professional organizations, consumer groups, state organizations and industry groups on high-priority topics such as serious and life-threatening diseases, imminent public health needs and other special health issues.
- Coordinates and implements policies, programs, and initiatives related to MedWatch including the MedWatch web pages, E-list, RSS feed, and Twitter account.
- Assures that patient perspectives are taken into consideration during drug development and policy issues through the patient representative and patient consultant programs. OHCA encourages and supports active participation of these groups in forming FDA regulatory policy to assure the agency’s decisions are based upon a full range of perspectives.
- Administers MedWatch, the FDA safety information and adverse event reporting program. The Office also provides education and information on FDA’s key responsibilities particularly, the drug approval process, clinical trial design, and expanded access to investigational therapeutic products.
Office of Health and Constituent Affairs
10903 New Hampshire Avenue
Bldg. 32, Room 5367Silver Spring, MD 20993