FDA Revises Labeling Regulations For Drugs Used During Pregnancy, Breastfeeding
The FDA announced a revision to existing system which governs the labeling drug makers must include with prescriptions to explain the risk and benefits of their medications during pregnancy and breastfeeding.
According to the FDA, there are over six million pregnancies in the U.S. per year, and pregnant women, on average, need to take between three and five prescription medicines.
This final rule has been in development since 2008, and the required information will be far more comprehensive, covering both prescription drugs and biologic products.
Sanda Kweder, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, explains, “The FDA wants pregnant and breastfeeding women and their health care providers to benefit from the most useful and latest information about their prescription medicines.”
The existing system used letter categories A, B, C, D, and X to classify risks. Sandra Kweder explained that this system confused patients and oversimplified their view of risk. According to Kweder, patients were misinterpreting the system as a grading system.
Kweder said, “Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal, and infant risk-benefit considerations.”
The new system will provide three subsections to provide available information for “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential.” In the literature, patients will be able to evaluate the medications effect on mother, fetus, and a breast-fed child using data and a comprehensive summary to explain the significance of the numbers.
The pregnancy subsection will include information about a registry that collects data on the effect of the drug on pregnant women and their babies. Drug makers can then use this data for future revisions to their literature and clinical testing of the drug. Previously recommended, this feature will now be required.
Much of the information has always been included in drug literature, but its new format and placement means to improve patient understanding and adherence.
The new rules will go into effect on June 30, 2015 and all new drug applications will be expected to comply with the requirements. Older medications will be updated gradually.
The FDA plans to issue a guidance explaining the new labeling regulations and will be accepting comments starting on December 4th.