FDA Issues New Drug Label Rules to Better Inform Pregnant Women. By Robert Preidt. nlm.nih.gov. December 03, 2014. Agency official says labeling changes should help patients 'make critical decisions' about medicines. A new labeling system should give women and their doctors clearer information on the risks and benefits of prescription medicines when taken during pregnancy and breast-feeding, the U.S. Food and Drug Administration said Wednesday.The agency "wants pregnant and breast-feeding women and their health care providers to benefit from the most useful and latest information about their prescription medicines," Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, explained in an agency news release.
"The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breast-feeding child," she added.
The new regulations are aimed at labels on prescription drugs and biological products, and will take effect for newly approved drugs beginning on June 30 of next year. Older drugs will have their labels changed more gradually, the FDA said.
Right now, drugs are labeled by a series of lettered categories -- A, B, C, D and X -- that used to classify the risk of using medicines during pregnancy and breast-feeding.
According to Kweder, that system "was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk."
So, beginning next June, the lettered system will be replaced with three detailed subsections -- "Pregnancy," "Lactation" and "Females and Males of Reproductive Potential," the FDA said.
The new labeling should mean that "doctors will have up-to-date and well-organized information on pregnancy and lactation. They will be in a better position to help their patients make critical decisions," Kweder said.
She added that providing this information in a clear manner is important, because the typical woman in the United States takes an average of three to five prescription drugs during a pregnancy.
Many pregnant women have chronic medical conditions, such as asthma or high blood pressure, and need to continue taking prescription drugs to treat those conditions during pregnancy and breast-feeding. Other pregnant women may need to take medicines for new conditions that develop during pregnancy or for health problems that worsen during pregnancy, the FDA said.
Also, changes that occur to a woman's body during pregnancy may affect the medication dose she requires, Kweder said.
The "Lactation" subsection on the new labels will provide more information on whether or not a medicine gets into breast milk and how that may or may not affect a breast-feeding infant. The "Females and Males of Reproductive Potential" subsection will also offer information about pregnancy testing, birth control and how a medicine affects fertility, the FDA said.
"For medications that may cause infertility or present risks in pregnancy, the revised labeling will include information to be considered when deciding such issues as birth control or planning a pregnancy," Kweder said.
It could take drug makers several years to make all the required label changes on older medications, according to the FDA.
"The greatest benefit to patients is that these changes will result in better-informed prescribing based on the latest scientific information for thousands of medical products," Kweder said.
Dr. Jacques Moritz, director of gynecology at Mount Sinai St. Luke's and Mount Sinai Roosevelt in New York City, welcomed the FDA's move.
"The alphabet grading system that was used previously was both antiquated and confusing," he said. "This is a great day for both pregnant women and physicians. Now patients are empowered to make a decision based on the risks and benefits of the drug in pregnancy and lactation. It is a much needed change from the previous system."
SOURCES: U.S. Food and Drug Administration, news releases, Dec. 3, 2014; Jacques Moritz, M.D., director of gynecology, Mount Sinai St. Luke's and Mount Sinai Roosevelt, New York City
Read also: FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products
December 3, 2014
The U.S. Food and Drug Administration published a final rule today that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.
The final rule replaces the current product letter categories – A, B, C, D and X – used to classify the risks of using prescription drugs during pregnancy with three detailed subsections that describe risks within the real-world context of caring for pregnant women who may need medication.
“Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations. The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk,” said Sandra Kweder, M.D, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child.”
The final rule requires the use of three subsections in the labeling titled “Pregnancy,” “Lactation” and “Females and Males of Reproductive Potential” that provide details about use of the drug or biological product. The detailed subsections must include a summary of the risks of using a drug during pregnancy and breastfeeding, a discussion of the data supporting the summary and relevant information to help health care providers make prescribing and counseling decisions.
- The Pregnancy subsection will provide information relevant to the use of the drug in pregnant women, such as dosing and potential risks to the developing fetus, and will require information about whether there is a registry that collects and maintains data on how pregnant women are affected when they use the drug or biological product. Information in drug labeling about the existence of any pregnancy registries has been previously recommended but not required until now.
- The Lactation subsection will provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed child.
- The Females and Males of Reproductive Potential subsection will include information about pregnancy testing, contraception and about infertility as it relates to the drug. This information has been included in labeling, but there was no consistent placement for it until now.
The “Pregnancy” and “Lactation” subsections will also include three subheadings: “risk summary,” “clinical considerations” and “data.” These subheadings will provide more detailed information regarding, for example, human and animal data on the use of the drug, and specific adverse reactions of concern for pregnant or breastfeeding women.
There are over six million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Women with pre-existing medical conditions, such as asthma or high blood pressure, may need to continue to use prescription drugs to treat those conditions during pregnancy and breastfeeding. Women may also need to take medications for new or acute conditions that may occur during pregnancy or breastfeeding. The new labeling format and requirements reorganizes information and is structured to help inform health care professionals’ prescribing decisions and the counseling of patients using prescription drugs.
The final rule is part of a broad effort by the agency, which began with the Physician Labeling Rule, to improve the content and format of prescription drug labeling.
The rule finalizes many of the provisions in the proposed rule that the FDA issued in May 2008, and will be in effect as of June 30, 2015. Once the final rule is in effect, newly approved drug and biological product applications will be required to use the new format immediately, while the new labeling content and format requirements for previously approved products subject to the Physician Labeling Rule will be phased in gradually.
The FDA is also issuing a draft guidance for industry to help drug and biological product manufacturers comply with the new labeling content and format requirements. The draft guidance provides a detailed description of how the labeling is to be formatted subsection-by-subsection, noting the type of information that should be included under each heading. Although comments on a guidance can be submitted at any time, public comments should be submitted within 60 days of publication to ensure that they are considered when the FDA begins work on finalizing the draft guidance.