FDA Announces Drug Study Program; Consumers, Doctors Respond

by Sokolove Law

The U.S. Food and Drug Administration (FDA) is teaming up with private agencies to make things a lot more clear for expecting mothers, with a brand new program called the Medication Exposure in Pregnancy Risk Evaluation Program or MEPREP.

A Dec. 30, 2009 FDA news release reveals that the federal agency is going to work with several other groups including Kaiser Permanente, Vanderbilt University, and the HMO Research Network Center for Education and Research in Therapeutics (CERT).

The result? More about the risks of using specific drugs during pregnancy.

Margaret Hamburg, M.D., Commissioner of Food and Drugs, has stated that MEPREP will “guide regulatory policy and influence medical practice.”

Prior to this new program, the FDA relied on a “grade” system for determining the risks of various pharmaceuticals for pregnant women. This grading system often left many questions about whether a medication represented an acceptable risk for any given patient.

Grassroots pregnancy advocacy groups are duly positive about the FDA decision.

“It needs to be done,” posted jeannesager on Jan. 4, on the parent advocate blog StrollerDerby, dubbed ‘The Mother of All Parenting Blogs.’

Other big advocacy blogs are looking forward to the change, as are some of the main participants.

Vanderbilt online sources show that William Cooper, M.D., M.P.H., professor of Pediatrics, has been selected as the principal investigator representing the school’s involvement in the program.

“This [MEPREP] will allow us to look at exposures we would never have been able to study before,” said Cooper in December, according to the internal news release.

Reports also quote Gerald Dal Pan, M.D., director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research, saying that MEPREP will “provide valuable information for physicians and patients” about using various drugs during pregnancy.

The MEPREP program is a valuable New Year’s present to American families. The hope is that this new initiative will make talking to doctors about drug regimens for expecting and new mothers more concrete, and help to prevent some of the range of birth injuries and birth defects that can be caused by side effects of some pharmaceuticals.

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