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U.S. Reps. Jaime Herrera Beutler, Kathy Castor Introduce Bipartisan Bill to Improve Research on Medication Used During Pregnancy and Breastfeeding

Pregnant women with chronic conditions are at greater health risk from lack of information about how medication will affect them

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Washington, DC, May 12, 2016 | comments
Today, U.S. Representatives Jaime Herrera Beutler (R-WA) and Kathy Castor (D-FL) introduced the Safe Medications for Moms and Babies Act, legislation that will increase safety for women who are pregnant and breastfeeding and must take medication.
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Today, U.S. Representatives Jaime Herrera Beutler (R-WA) and Kathy Castor (D-FL) introduced the Safe Medications for Moms and Babies Act, legislation that will increase safety for women who are pregnant and breastfeeding and must take medication. This bipartisan solution will identify major research gaps involving pregnant and lactating women who take prescription medication, and detail ways to promote safer medications for them to use.  

There is very little research to show the potentially unique effects of medication on mothers during pregnancy and lactation. Women who take medication for chronic conditions or an isolated event have to make a decision to take a medication that could have unknown impacts on their health or the health of their baby – or they could forgo medication and suffer other health risks as a result.   With nearly 4 million women in the U.S. giving birth annually and more than 3 million breastfeeding their infants, better data is needed for moms to make informed decisions about their health. 

The Safe Medications for Moms and Babies Act will establish a taskforce of federal and medical experts to advance research and information sharing on medication use during pregnancy and breastfeeding. The task force will report to Congress: 

  • a plan to identify and address gaps in knowledge and research regarding safe and effective medications for pregnant women and lactating women;
  • ethical issues around the inclusion of pregnant women and lactating women in clinical research;
  • the state of federal research involving pregnant and lactating women, recommendations for the coordination of, and collaboration on, research related to pregnant and lactating women.

The bill also requires an annual report from the Food and Drug Administration on the number of medications that included pregnant women or lactating women in trials, and the number of new drugs with post-market studies.

The Safe Medications for Moms and Babies Act is supported by March of Dimes, American Academy of Pediatrics, the Society for Maternal-Fetal Medicine and the American Congress of Obstetricians and Gynecologists.

“While medicine has made amazing advances in the past 75 years, there’s undoubtedly a gap in what we know about the effects of medication on pregnant women and their babies. It’s critical that expectant mothers have the information to make the best decisions when it comes to taking medication.  I appreciate Congresswoman Castor’s partnership in fixing the gap, and better protecting the health of mothers and infants.” – U.S. Rep. Jaime Herrera Beutler (WA-3)

“Expectant mothers and their doctors should have adequate and accurate information about effects of medications used during pregnancy as well as when nursing to ensure the best health outcomes for our most vulnerable ones. We know too little about current medications on the market and their risks for mother and child -- more research must be done. I thank U.S. Rep. Herrera Beutler for joining me in leading this effort with the Safe Medications for Moms and Babies Act, aimed at improving the quality of data and information on medication use during pregnancy and breastfeeding.” –  U.S. Rep. Kathy Castor (FL14)

“It’s time to shift our approach from a system that protects pregnant women from research, to one that protects them through research. The Safe Medications for Moms and Babies Act will increase communication and collaboration among federal agencies already working on the safety of drugs and their impact on pregnancy.  The March of Dimes is grateful to Representatives Jaime Herrera Beutler (WA) and Kathy Castor (FL) for continuing to champion maternal and child health.” – March of Dimes President Dr. Jennifer L. Howse

“SMFM is so pleased that Representatives Herrera Beutler and Castor are leading this effort in the U.S. House of Representatives. SMFM has long supported more and better collaboration and coordination amongst and between federal agencies, experts, patients and industry when it comes to pregnant and breastfeeding women. This legislation is a great first step toward ensuring that health care providers and women get the information they need." – Mary Norton, M.D., president of the Society for Maternal-Fetal Medicine

“Just like any other patients, pregnant women may need medical treatment to control chronic or acute medical conditions. Unfortunately, many medications have not been thoroughly studied during pregnancy, so their effects on the fetus are unknown. The Safe Medications for Moms and Babies Act will help all doctors who care for pregnant women, including obstetrician-gynecologists, so they can confidently make prescribing decisions for their patients.” – Mark S. DeFrancesco, MD, MBA, President of the American Congress of Obstetricians and Gynecologists

“A healthy and safe pregnancy is an essential foundation for children to have the healthiest possible start in life. Women who are pregnant or breastfeeding and need to take medications deserve to know whether those medications are safe and effective. The American Academy of Pediatrics (AAP) is proud to endorse the Safe Medications for Moms and Babies Act, which will help ensure the federal government is maximizing the opportunities to inform women and their physicians about the safety of drugs taken during pregnancy and lactation. The bill would empower the federal government to generate data about the safety and effectiveness of medications taken during pregnancy and lactation, and to ensure that those medications are labeled to include that important information.” – American Academy of Pediatrics President Benard P. Dreyer, MD, FAAP

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