Following Senator Hassan’s Push, Prescription Drug Makers Improve Medication Labeling for Pregnant Woman

WASHINGTON, D.C. – Today, the Food and Drug Administration (FDA) confirmed that following a bipartisan push led by U.S. Senator Maggie Hassan (D-NH), prescription drug manufacturers have taken action to improve medication safety labeling for pregnant women.  

“Before 2015, FDA used a labeling system that made it hard for pregnant women to understand the health risks of different medications...The FDA replaced this system back in 2015 but as of earlier this year there were still several drugs on the market using the old system including common medications like antibiotics,” explained Senator Hassan at today’s hearing. “Doctor, has the Center for Drug Evaluation and Research brought all prescription drug manufacturers into compliance with pregnancy labeling standards?” 

“Yes, thank you, we now have submissions from all of the drugs that were outstanding,” said Dr. Jacqueline Corrigan-Curay, the Acting Director of the FDA’s Center for Drug Evaluation and Research, confirming that Senator Hassan’s bipartisan push to get drug manufacturers to take action was successful.

As of the beginning of this year, there were 17 medications on the market that used an outdated labeling system that makes it difficult for pregnant women to understand the health risks posed by these medications. For example, some of these medications used a single labelling category for two very different kinds of medications: medications where animal studies showed evidence of risk to pregnant women, and medications where there have been no studies at all on the risks to pregnant women. 

In 2015, the FDA moved to replace this labeling system with better information for pregnant women, including narrative descriptions of the health risks posed by medications. Unfortunately, as of earlier this year, the makers of 17 drugs had still not changed their labels and adopted the FDA's new and safer labeling system. 

Today the FDA announced that, due to a bipartisan push from Senators Hassan and Budd, the agency worked with drugmakers to finally replace outdated medication labels on 17 drugs with new labels that will provide clear information to pregnant women about health risks. The issue has been highlighted by experts, who applauded today’s move. 

“Navigating medications during pregnancy is extremely stressful for many women. I’m delighted to see the FDA moving to make medication labeling as helpful as possible during this time,” said Emily Oster, CEO of ParentData.   

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