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Background Analysis: US FDA Advisory Committee to Discuss the Impact of Labeling Changes Under the Pregnancy and Lactation Labeling Rule – MAR 5-6, 2018 (RCAC)


The US FDA has scheduled a Risk Communication Advisory Committee (RCAC) meeting Monday to Tuesday, March 5-6, 2018, to discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule. 


The Pregnancy and Lactation Labeling Rule (PLLR) was published in the Federal Register on December 4, 2014 (Docket No. FDA-2006-N-0515 (formerly Docket No. 2006N-0467). The rule required changes to the labeling of prescription drugs to better communicate clinically relevant information to healthcare providers on risks associated with medication exposure during pregnancy and lactation.

In particular, the PLLR replaced the pregnancy letter categories (A, B, C, D, and X), which the FDA had been using since the 1970s to communicate various types of risks for pregnant and breastfeeding women. The FDA concluded that this system was often misinterpreted as a sort of grading system of risks, which gave an overly simplified view of product risks.

The PLLR replaced this system with new labeling subsections about pregnancy and breastfeeding. The intent of the change was to provide better information on topics such as whether a medication gets into breast milk and how it can possibly affect the infant, pregnancy testing, birth control and a medication’s effect on fertility, for both women and men.

The PLLR was made effective on June 30, 2015. For approved drugs, the timeline for implementation varied between from 3-5 years from June 30, 2015, depending on a drug’s approval date. Applications that were under review on the effective date were given 4 years after the effective date or at the time of approval, whichever is later, to comply. All applications yet to be submitted after the effective data were required to comply with the new rule. Along with the new rule, the FDA issued relevant Draft Guidance in December 2014, entitled “Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format” (dated December 2014).

At the upcoming meeting, the FDA will seek input and recommendations from the RCAC on:

·      how information in PLLR labeling is being perceived and used by healthcare providers and other stakeholders;

·      factors that are critical to healthcare providers’ interpretation of the data and counseling of pregnant women on the risks and benefits of a medication; and

·      how to convey risk information to healthcare providers to accurately and adequately inform risk-benefit considerations for medication use during pregnancy.

What’s Next?

Tarius will send a Briefing Summary after briefing materials are posted to FDA’s website (typically within 2 days of the meeting). This report will provide a summary of the FDA’s briefing materials.

Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.

METADATA: Sponsor: none Drug Name: none Drug Class: none Indication: none

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DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.