Pregnancy & Lactation Labeling

The US Food and Drug Administration (FDA) recently passed a legally binding regulation revising the content and format of the Pregnancy, Labor and Delivery, and Nursing Mothers sections of the label for human drugs and biologics. The Pregnancy and Lactation Labeling Rule (PLLR) took effect on June 30, 2015 and requires the inclusion of much-needed additional information to help health care providers make informed prescribing decisions for specific populations. These include women who are pregnant (including those in labor and delivery), those who are lactating, and both females and males of reproductive potential. The result is a dramatically different format that contains increased detail, but also increased complexity.

The PLLR requires a new labeling format for all New Drug Applications (NDAs), Biologics License Applications (BLAs), and efficacy supplements. Importantly, labels approved from June 30, 2001 until the effective new rule date must also be revised under a under a staggered implementation schedule. Navigating the complexity of the new labeling format will require advanced planning and collaborative effort among nonclinical, clinical, and regulatory experts.

How Exponent Can Help

Exponent’s Center for Toxicology and Mechanistic Biology provides the highest quality technical, regulatory, and safety assessment services to assist our clients with issues related to pharmaceutical and biotechnology products. Our unique range of skills and experience in drug development and regulatory strategy allows us to advise our clients on compliance with changing drug labeling requirements.

Exponent staff can assist with the revision of previously approved labels. A key challenge in this effort will be to incorporate into the Risk Summary subsections clinical data generated in the intervening years. This could include data from Sponsor-generated studies, pregnancy exposure registries, and clinical/epidemiologic studies published in the scientific literature. Our toxicologists and epidemiologists assist clients in determining the quality of studies, which studies to include, how results affect the Risk Summary, and navigating conflicting results. Understanding how to relate disease risks in a consistent manner across the industry will be another challenge, and Exponent scientists help accomplish this within the Clinical Considerations subsection of the new labeling.

The newly added section for Females and Males of Reproductive Potential provides information for drugs with high concern for developmental toxicity (primarily teratogenicity) or potential risk to human fertility. Exponent toxicologists have specific expertise in developmental and reproductive toxicology, positioning us to efficiently and accurately assist in preparing content for the PLLR.