Parker Waichman LLP

FDA to Study Effect Of Prescription Drugs on Pregnant Women

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 […]

A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of <"https://www.yourlawyer.com/practice_areas/defective_drugs">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.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
My husband and I would like to personally thank Ashley Lopilato and Parker Waichman for their assistance in having a successful outcome through a long and very difficult process. It was a relief to have Ashley and the staff follow-up on the status of our claim and keeping us informed. It was worth the wait! We recommend Parker Waichman to handle your legal needs.
Yolanda Quinones
3 years ago
5 Star Reviews 150
I would like to extend my gratitude to both Julie Trinidad and Marianne Gallizzi. They are part of a great team in Parker Waichman. I appreciate the time and effort you took to answer all of my questions.
Karyna Minchala
5 years ago
5 Star Reviews 150
Excellent service
Cris Valdueza
6 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038