FDA Office of Women’s Health Pregnancy Exposure Registry Website

1. Beverly Gallauresi RN, MPH Health Programs Coordinator AANP June 24, 2011 FDA Office of Women’s HealthPregnancy Exposure Registry Website

2. About FDA • The oldest consumer protection agency in the U.S. • Ensures that regulated products are safe and effective.

3. What FDA Regulates Human Drugs Biologics Foods Cosmetics Tobacco Products Medical Devices and Radiological Health Animal Drugs, Feed, and Testing

4. Women were not adequately included in clinical studies Lack of understanding of sex/gender differences Why Does FDA Have An Office Of Women’s Health? 1992 GAO Report

5. FDA Office of Women’s Health (OWH) • Created in 1994 by Congressional mandate to: • Correct gender disparities in FDA drug, device, biologics testing and regulation policy • Oversee the implementation of revised clinical trial guidelines with respect to representation of women

6. FDA OWH Mission • Protect and advance the health of women through policy, science, and outreach • Advocate for inclusion of women in clinical trials and analysis of sex/gender effects

7. What is a Pregnancy Exposure Registry? • A study sponsored by a drug company • Collects health information from women who take medicines and vaccines when they are pregnant • Information is compared with women who have not taken medicine during pregnancy • Also collects information on the newborn infant

8. Why Use Exposure Registries? • ~64% of woman are prescribed one or more drugs during pregnancy • Many enter pregnancy with chronic health problems that require continuous or intermittent use of medicine • Pregnant women are often excluded from clinical trials • Pregnancy Exposure Registries provide pregnancy and fetal outcomes data • Data will improve product labeling • Enable healthcare practitioners to better inform women about prescription drug use while pregnant

9. Why Use Exposure Registries? • Drug companies can’t test medicine on pregnant women • Labels on most medicines have little or no information about its effect the mother or the fetus • Little or no information exists about how medicines could affect a woman or her fetus • Best way to learn about effects of using medicines during pregnancy • Help women decide about taking medicines during pregnancy • Help improve drug labeling in the future

10. Benefits of Using a Registry • Short Term • Learn of pregnancy exposure registries available to help your patients • No immediate gratification—not a quick fix • Long Term • Help your patients decide whether to take a medication during pregnancy • Improve drug labeling for products used by pregnant women

11. What the Pregnancy Exposure Registry Website Offers • Defines pregnancy registries • Provides registry information • Registry name • Medication being studied • Registry contact information for enrollment • Facilitates enrollment into a registry

12. How to Use the Registry • Go to the website • Search by • Specific medical condition • Specific medication • Specific disease • Check to see whether the condition/medication/disease is among existing registries • Ask your patient about their willingness to participate in a registry • Contact the registry • The drug company that makes the medicine is usually in charge of the pregnancy registry. • Patients may need to sign up through their nurse, doctor or pharmacist.

13. Registry Website Development • Sponsors and consumers told FDA OWH they wanted information on pregnancy exposure registries • Created the registry website in 2002 • Redesigned the website in 2006 • Continuously updated • as new registries are added • as existing registries end/close

14. Role of FDA OWH • OWH keeps a list of all ongoing registries • OWH does not run pregnancy studies • OWH does not have regulatory authority • OWH does not review pregnancy exposure registry: • protocols • data • reports • labeling changes

15. Information FDA Gathers • Drug companies provide FDA with: • Medical product name • Registry name • Registry contact information • Phone number, organization name, website • Start date of registry • Whether protocol has been reviewed by FDA and found acceptable • Proposed end date of registry or when the number of pregnant women to be included in the registry is reached

16. Criteria for Listing Registries • Each registry is a post marketing commitment or a post marketing requirement • Sponsors or research institutions may request a listing • Protocol must be reviewed by CDER or CBER to ensure scientific integrity

17. Industry & Reviewer Guidance • Guidance for Industry • Establishing Pregnancy Exposure Registries http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071639.pdf • Reviewer Guidance • Evaluating the Risks of Drug Exposure in Human Pregnancies • http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071645.pdf

18. Exposure Registries on the Website • 43 registries currently listed (6/14/2011) • Split into three sections: • Registries specific to a medical condition • Study multiple drugs for one condition • Diabetes, Asthma, Depression • Registries specific to a medication • Januvia, Exenatide, Keppra, Singulair, Xolair, Wellbutrin, Zyban, Cymbalta • Drugs/vaccines used in registries for specific diseases • HIV/AIDS medication for antiretroviral pregnancy registry • Chemotherapy drugs for cancer and childbirth registry • Epilepsy medication for AED pregnancy registry • Immunosuppressant medication for national transplant registry • Autoimmune disease medications for OTIS autoimmune diseases registry

22. For More Information • FDA Office of Women’s Health http://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofWomensHealth/default.htm 301-796-9441 • Organization of Teratology Information Specialists (OTIS) http://www.otispregnancy.org/ 866-626-6827