FDA FDA Office of WomenOffice of Women’’s Health (OWH) s Health (OWH)

Beverly Gallauresi, MPH, RNBeverly Gallauresi, MPH, RN

Food and Drug AdministrationFood and Drug AdministrationOffice of WomenOffice of Women’’s Health s Health

Health Programs Coordinator Health Programs Coordinator

June 23, 2010June 23, 2010

FDA Office of WomenFDA Office of Women’’s Health s Health (OWH)(OWH)

Created in 1994 by Congressional mandate to:Created in 1994 by Congressional mandate to:

–– Correct gender disparities in FDA drug, Correct gender disparities in FDA drug, device, biologics testing and regulation policydevice, biologics testing and regulation policy

–– Oversee the implementation of revised clinical Oversee the implementation of revised clinical trial guidelines with respect to representation trial guidelines with respect to representation of womenof women

FDA OWH MissionFDA OWH Mission

Protect and advance the health of women Protect and advance the health of women through policy, science, and outreachthrough policy, science, and outreach

Advocate for inclusion of women in Advocate for inclusion of women in clinical trials and analysis of sex/gender clinical trials and analysis of sex/gender effectseffects

Why is OWH interested in the Transradial Why is OWH interested in the Transradial Thinktank?Thinktank?

Studies have shown that women greater risk of bleeding complications than men with some medical devices

Example of OWH funded project: “Risk of local adverse events by gender following cardiac catheterization”– by Dale R. Tavris MD, MPH, et all., published in

Pharmacoepidemiology and drug safety 2007; 16: 125–131

What OWH would like the Registry to What OWH would like the Registry to capture/analyze capture/analyze

Age, Race, Sex dataAge, Race, Sex data

Analysis of data by sex/genderAnalysis of data by sex/gender

Questions, please call/eQuestions, please call/e--mailmail

Beverly Gallauresi, MPH, RNBeverly Gallauresi, MPH, RN

–– 301 796301 796--94389438–– beverly.gallauresi@fda.hhs.govbeverly.gallauresi@fda.hhs.gov