FDA unveils new labelling rules for detailing drug risks during pregnancy, breastfeeding

The FDA on Wednesday published a final rule concerning how information about using medicines during pregnancy and breastfeeding is included on labels for prescription drugs and biological products. Sandra Kweder, deputy director of the Office of New Drugs in the agency's Center for Drug Evaluation and Research, said "the new labelling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the foetus and the breastfeeding child."

Kweder noted that the current product letter categories used to classify the risks of using prescription drugs during pregnancy "was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk." The FDA said that the new labelling requirements, which will consist of detailed subsections that describe risks within a "real-world context", will provide a more consistent way to include relevant information about the risks and benefits of medicines used during pregnancy and breastfeeding.

According to the regulator, the new system requires the use of three subsections, namely Pregnancy, Lactation and Females and Males of Reproductive Potential, which will provide information on the risks of drugs or biologics. For each section, drugmakers will be required to summarise the risks of using a drug or biologic during pregnancy and breastfeeding, discuss the data supporting the summary and provide relevant information to assist healthcare providers make prescribing and counselling decisions.

However, the FDA cautioned that revising the labelling system "is a large undertaking that will take several years," adding that it will cost as much as $78.2 million to comply with the new rule. Kweder indicated that newly approved drugs will have to comply with the rule by June 30, while currently available therapies will be phased in over the next three to five years.

Meanwhile, the FDA also on Wednesday issued draft guidance to help drugmakers comply with the new labelling and format requirements. The agency stated that the draft guidance "provides a detailed description of how the labelling is to be formatted subsection-by-subsection, noting the type of information that should be included under each heading."

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