Statement of Laurén Doamekpor, Ph.D. at the FDA Pregnancy Registries Meeting

May 28, 2014

Good afternoon,
My name is Dr. Laurén Doamekpor, and I am a senior fellow at the National Center for Health Research. Thank you for the opportunity to speak today at this important meeting. Our non-profit research center assesses scientific and medical data and provides objective health information to patients, providers and policy makers.

We recognize the vital importance of requiring post-market pregnancy registries. These registries will provide information to improve product labeling and enable healthcare providers to better inform women about prescription drug use during pregnancy. Even when risks are uncertain, data from registries can provide valuable insight into the potential risks from exposure to drugs or biologics. It is incredibly important that pregnancy registries use rigorous methodology and protocol to ensure that the data is scientifically sound.

Our comments today address the need to ensure an adequate sample size that is sufficiently diverse and the need for a systematic surveillance system for all marketed drugs used by women of childbearing age.

Pregnancy exposure registries tend to be too small and have often not recruited sufficient numbers of racial and ethnic minorities. This lack of diversity is a problem for many studies submitted to the FDA. For pregnancy registries, this problem may be particularly pronounced because of the way women are recruited and enrolled. Enrolling women through physicians’ offices, for example, may limit the number of participants from ethnic minority groups because minorities are less likely to have health insurance or to have regular prenatal care. The physicians they see, in emergency rooms or clinics, may be less likely to participate in registries.

Successful recruitment of women of color will require new strategies for recruiting patients. A carefully created plan is needed to recruit in community health centers and urgent care centers. A continued partnership with text4baby and other social media platforms used by a diverse group of patients is also essential. Whenever possible, enrolling women directly into registries, independent of physicians may be encouraged. This may allow for the inclusion of women earlier in pregnancy and facilitate follow-up.

The biggest challenge is obtaining information on a drug’s safety during pregnancy as quickly as possible after a new drug is marketed. However, registries are not required for all new drugs. The FDA should require pregnancy registries for all newly marketed drugs used by women of childbearing age. The agency should also require pregnancy registries for some older drugs that are widely used during pregnancy, but where safety data are lacking.

There is no systematic method for conducting registry studies. We don’t know if the samples are representative or not. It is essential that pregnancy registries be founded on methodologically sound protocols in order to produce scientifically sound data on the safety of drug use during pregnancy. This will help patients decide whether to take a medication during pregnancy or not.