The Food and Drug Administration (FDA) has teamed up with private sector and academic researchers in the US for a programme that will study the effects of prescription medicines taken during pregnancy.
The Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) is a collaboration between the FDA and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Vanderbilt University, and a number of research centres run by health plan Kaiser Permanente. The HMO Research Network is a consortium of health maintenance organisations (HMOs) in the US with recognised research capabilities.
Around two thirds of women who deliver a baby have taken at least one prescription medicine during pregnancy, according to an article published in the American Journal of Obstetrics and Gynecology. Due to concerns about the health of mother and child, though, very few clinical trials evaluate the safety of drugs in pregnancy, the FDA points out.
Researchers funded under the MEPREP initiative will link healthcare information on mothers and their babies from population-based databases maintained by each of the 11 health plan-affiliated sites participating in the programme. The co-ordinating centre is the HMO Research Network CERT Data Center at the Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute.
Together, the 11 participating research centres hold healthcare information on some million births that took place between 2001 and 2007. “Many of the mothers associated with these births likely used medication during their pregnancies and now, with the programme in place, the FDA and participating researchers have a systematic and timely way of retrieving information from this network,” the agency commented.
Dr Margaret Hamburg, Commissioner of Food and Drugs, said data gathered under the programme would guide regulatory policy and influence medical practice.
A steering committee comprising representatives from each of the participating sites and the FDA will oversee MEPREP activities and provide scientific leadership for the programme. The committee chair and FDA project lead is an agency epidemiologist, Dr Pamela Scott.
