1. Bringing Science to Consumers: Designing Appropriate Health Education Materials Alison Lemon, MHS Food and Drug Administration Office of Women’s Health

2. Oldest consumer protection agency in the U.S. Ensures that regulated products are safe and effective.

3. What FDA Regulates Animal Drugs, Feed, and Testing FoodsBiologics Human Drugs Cosmetics Medical Devices and Radiological Health

4. OWH Mission Statement FDA’s Office of Women’s Health Protects and advance the health of women through policy, science and outreach Advocates for the inclusion of women in clinical trails as well as sex/gender and subpopulation analyses

5. Outreach Strategy

7. Take Time To Care Umbrella Theme For Campaigns Diabetes Pink Ribbon Sunday (Mammography) Menopause and Hormones Health Fraud

8. Quality Materials Development (2 year process) HHS Requirements – advance approval of concepts Staff Expertise Drafts Approved by Centers Human Subject Protection = IRB, RIHSC Formal Focus Testing in English and Spanish (locally and in field) Evaluations require OMB clearance

9. Publication Distribution Distributed over 3.5 million publications in 2006 Received GSA Consumer Choice Award from FCIC FDA/OWH most requested source of health information in HHS 7 consecutive years FDA Public Affairs Specialists National Organizations 75 conferences every year

10. Fact Sheets Allergies Antibiotic Resistance Asthma & Hay Fever Botox Buying Contacts Online Cell Phones Clinical Trials Contact Lens Care Cosmetics Depression Diabetes Diabetes Recipes Dietary Supplements Fibroids The Flu Food Safety at Home Food Safety for Seniors Food Safety/Take- Out Generic Drugs Whole Body CT Imaging Hair Dye /Straighteners Heart Disease High Blood Pressure Incontinence Infertility Lasik Surgery Liposuction Listeria Lung Cancer Mammograms Menopause My Medicines Osteoporosis OTC Drugs Pap Tests Sleep Disorders Stroke Sunscreens Tattoos Using Medicines Wisely West Nile Virus

11. Fact Sheets New design & layout Updated contents Color groupings

14. Medicine Charts HIV &AIDS Depression Smoking Menopause High Cholesterol High Blood Pressure Birth Control

15. Why Medicine Charts? Response to the public Direct to consumer advertising Balanced, simplified information Based on the label

16. The Process Original draft based on the label Reviewed by appropriate centers Back and forth process Sign off by center directors Focus groups

20. 2003 OWH Birth Control Chart

24. Join Us! www.fda.gov/womens w

25. Acknowledgements: Marsha Henderson, MCRP Kimberly Thomas, MPH Susana Perry, MS Deborah Kallgren, BS