A final draft rule, which is scheduled to be published in the National Register on Thursday, will replace a decades-old labeling system that used letters of the alphabet to describe risk.
At a news conference Wednesday, Dr. Sandra Kweder, deputy director of the office of new drugs at the FDA's Center for Drug Evaluation and Research, told reporters that the old letter system was "extraordinarily misleading."
"Instead, the new format will require that labeling include a summary of the risks of using a drug during pregnancy and while breastfeeding an infant," Kweder said.
"This information has been in labeling all along, but it's been scattered throughout the label and very difficult to find. We're putting it all in one place," Kweder said.
The new regulation, which takes affect June 30, concerns physician prescribing information, or so-called package inserts, and will not change the labeling consumers find on the outside of pill containers that they get at the pharmacy, officials said.
Under the new rule, package inserts will now feature three subsections entitled "pregnancy," "lactation" and "females and males of reproductive potential."
The pregnancy subsection will include information on dosing and potential risks to a developing fetus and carry information on any registries that collect data on how the drug affects expectant mothers. While past regulations have recommended including information about such registries, it will now be required.
The lactation subsection will provide information on how much of the drug will transfer to breast milk and the potential effects it could have on a breastfeeding child.
The subsection on reproductive potential will include information on a drug's influence on pregnancy testing, contraception and infertility. While this information is already included in labeling, its placement has been inconsistent.
According to the FDA, there are over 6 million pregnancies in the U.S. each year, and pregnant women take an average of three to five prescription drugs during pregnancy. While some drugs are taken for conditions related to pregnancy, or for illnesses that occur during pregnancy, other women take drugs for preexisting conditions such as asthma or high blood pressure.
Kweder told reporters that drug manufacturers would now have to ensure that their labeling reflected current research on a drug's effect on pregnant women. Up until now, this wasn't always the case, she said.
"Often times the research is out there in the medical literature and often times companies know about that information ... and they have chosen for whatever reason not to update their labeling," Kweder said. "This pushes the envelope and says you need to do that."