FDA to Study Effect Of Prescription Drugs on Pregnant WomenDec 31, 2009 | Parker Waichman LLP
A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy, the U.S. Food and Drug Administration (FDA) just announced. The program is a collaboration among the FDA and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centers, and Vanderbilt University.
About two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy according to a journal article published in the American Journal of Obstetrics and Gynecology. There are very few clinical trials that test the safety of medications in pregnancy due to concerns about the health of the mother and child. “This program is a great example of FDA and the private sector working together to improve the health of pregnant women and their children,” said Margaret Hamburg, MD, Commissioner of Food and Drugs. "These data will guide regulatory policy and influence medical practice," Dr. Hamburg added.
To overcome the challenges presented by the lack of clinical trial data about the use of medications during pregnancy, the research program will link health care information for mothers and their babies in each of the participating research sites. Collectively, the 11 participating sites have health care information for about one million births over the past seven years. It is believed that many of the mothers associated with these births likely used medication during their pregnancies and now, with the program in place, the FDA and participating researchers have a systematic and timely way of retrieving information from this network.
“This collaborative effort creates a unique resource to study the effects of medication in pregnant women and their children,” said Gerald Dal Pan, M.D., director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research. “Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy.”
The program blends clinical and research expertise and population-based databases from 11 health plan-affiliated research sites including Kaiser Permanente (Northern California, Southern California, Georgia, Pacific Northwest, and Colorado regions); Harvard Pilgrim Health Care Institute, Group Health Research Institute, HealthPartners, Lovelace Clinic Foundation, the Meyers Primary Care Institute, and Tennessee State Medicaid, and the FDA, said the agency. The HMO Research Network CERT Data Center at the Department of Population Medicine of Harvard Medical School and Harvard Pilgrim Health Care Institute, led by Richard Platt, M.D., M.S., is the program’s coordinating center.
The investigators have collaborated on numerous studies related to medication use during pregnancy and birth outcomes, including studies on the effects of anti-depressant medications, antibiotics, and cardiovascular medications on birth defects and perinatal outcomes.A Steering Committee composed of representatives from each site and the FDA will oversee MEPREP activities and provide overall scientific leadership.