Labels Without Categories: A Workshop on FDA’s Pregnancy and Lactation Labeling Rule

The recently finalized Pregnancy Labeling and Lactation Labeling Rule changes the organization of the current Pregnancy and Nursing Mothers section of the US package insert of prescription drugs. In response to these changes in prescription drug labeling, the HESI Developmental and Reproductive Toxicology (DART) Technical committee sponsored a two-day workshop on this topic.

This workshop aimed to:

(1) provide a forum to discuss the impact of the PLLR;
(2) train relevant industry professionals on how to write labels according to the new rule;
(3) provide feedback to the US FDA.

The final workshop program is available here.

Workshop Sessions

• Introduction to the Pregnancy and Lactation Labeling Rule, Melissa Tassinari, US FDA
• Pregnancy and Lactation Labeling Rule: Targeting the Audience, Shari Lusskin, Mount Sinai Medical Center (ETS Presentation)
• Clinical Use of Labels, Shari Lusskin, Icahn School of Medicine, Mount Sinai Medical Center
• Writing Risk Summaries - Human, Animal & Pharamacologic, Mary Ellen McNerney, Bristol-Myers Squibb
• Using Animal Data to Communicate Human Risk, Tacey White, Exponent
• Clinical Considerations, Anthony Scialli, Reproductive Toxicology Center
• European Perspective on Drug Labeling Without Categories, Jan Willem van der Laan, Medicines Evaluation Board
• Incorporating Clinical Information into the Label, Janet Hardy, The ECC Population Health Group LLC
• Incorporating Human Data, Christina Bucci-Rechtweg, Novartis (ETS Presentation)
• New Technologies to Collect Pregnancy and Lactation Data, Diego Wyszynski, Boehringer Ingelheim
• Section 8.3 - Females and Males of Reproductive Potential, Lynnda Reid, US FDA
• PLLR: Subsection 8.3 - Femals and Males of Reproductive Potential, Paul Barrow, Roche (ETS Presentation)

Please contact Mr. Oscar Bermudez (obermudez@hesiglobal.org) for addtional information.