FDA revises draft PLLR guidance

The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance providing recommendations on the content and format of labeling required under the pregnancy and lactation labeling rule (PLLR).
 
The draft guidance was first issued alongside the final PLLR in 2014, with the rule itself taking effect in June 2015. The PLLR revised labeling requirements under the 2006 physician labeling rule, to “provide a framework for clearly communicating information on the risks and benefits of using a drug during pregnancy and lactation to facilitate prescribing decisions,” as well as to introduce a new subsection to address specific issues for patients of reproductive potential.
 
FDA says the revisions to the draft guidance provide clarification and additional information in four areas gleaned from experience implementing the PLLR and public comments to the original draft guidance.
 
The revised draft guidance offers drugmakers more flexibility in adding new subsections other than those provided in Appendix A compared to the previous version. Instead of saying that additional subdivisions “are not recommended,” FDA now says new headings or subheadings “can be used to convey important information.
 
“If a new subheading is proposed, the applicant should provide justification for the proposed heading or subheading for Agency review,” FDA writes.
 
A new section on omitted information is also included in the revised draft guidance, in which FDA explains that, “In some circumstances applicants must omit certain subsections or specific information otherwise required under the PLLR because it is clearly inapplicable or misleading.” FDA provides the example of a drug intended solely for neonates omitting the Pregnancy and Lactation subsection. FDA says applicants should provide a rationale and justification for any proposed omissions.
 
For pregnancy exposure registries, FDA now notes that multidrug pregnancy exposure registries should be referenced and advises applicants that labeling must be updated if an existing registry is closed or if there are changes to the contact information for the registry.
 
FDA also makes various clarifications to the section on the Risk Summary heading, including revised recommendations for risk statements based on human and animal data.
 
The section of the guidance on subsection 8.3 Females and Males of Reproductive Potential has been expanded to include recommendations for addressing pregnancy testing, contraception and infertility in labeling.
 
The agency has also updated the section covering procedural information related to PLLR implementation and submitting draft labeling for FDA review.