Understanding the new FDA pregnancy and lactation labeling rules☆

Dermatologists should be aware that the new Pregnancy and Lactation Labeling Rule (PLLR) has taken effect on June 30th, 2015. This mandate from the Federal Drug Administration (FDA) eliminated the standard pregnancy category letters for prescription medications (A, B, C, D and X). The new recommendations are now in the form of drug labeling that contains increased detail but also increased complexity. This editorial describes the newdrug-labeling rule and its potential impact in clinical dermatology. The PLLR introduced a new drug labeling schema to help physicians better communicate the risks and benefits of pharmacologic treatment to patients during pregnancy and lactation. Sandra Kweder, M.D., Deputy Director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, stated, “The previous letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk.” (US Food andDrugAdministration, 2015) Consequently, the new package insert content and formatting requirements aim to provide a more consistent way of disclosing relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding. However, some have expressed criticism of the PLLR. Many question how labels will be revised to reflect new data as it becomes available. Drugmanufacturers face a significant challenge in condensing vast amounts of varying quality data into concise, clear paragraphs. Despite these challenges, the rule immediately applies to all drugs approved by the FDA after June 30th 2015 and requires that all labels be continually updated as new information becomes available (US Food and Drug Administration, 2015). Pregnancy labels for products approved between 2001 and June 30th 2015 will be revised using a staggered implementation schedule, and those approved before 2001 must be revised within 3 years (US Food and Drug Administration, 2015). To aid in transition, the FDA issued draft guidance to assist drug manufacturers in complying with the new labeling content and format requirements (US Food and Drug Administration, 2015). Unfortunately, labels for over-the-countermedications are not affected by the PLLR. The most notable change of the PLLR is that it will remove arbitrary and often misinterpreted pregnancy-labeling categories for pharmaceuticals (A, B, C, D, X). Instead, package inserts will now