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THE PHARMA REVIEW (NOV – DEC 2018)

FDA’s New Pregnancy and Lactation Labeling Rule: Propitious to Maternal Health

Niyati Mehta, Mansi Patel & Priti Mehta

Introduction:

Abstract: The pregnancy and lactation medications presented a challenge to all health care professionals. This was especially true with the long-standing pregnancy risk categories A, B, C, D, and X, which made risk-benefit ratio assessment difficult. Numerous medications had been used safely and effectively in pregnancy with minimal risk to the fetus and mother, although the decision to use them was not without apprehension. The availability of more thorough information related to the safety and effectiveness of medications in pregnancy and lactation could help healthcare professionals and patients to make decisions that were evidence-based. To address need for updated risk categories, final rule named “Content and Format of Labeling for Human Prescription Drug and Biological Products: Requirements for Pregnancy and Lactation Labeling” was published by the Food and Drug Administration (FDA), which is also known as “Pregnancy and Lactation Labeling Rule” (PLLR), December 2014. Along with the PLLR, the FDA issued a draft document entitled “Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format” to serve as guidance to industry in preparing PLLR compliant drug applications. The PLLR represented an important departure from the previously established pregnancy categories, initially implemented in the FDA’s labeling for Prescription Drugs Used in Men regulations (1979). These regulations required the assignation of a pregnancy letter category (A, B, C, D, or X) to medications Under the PLLR, these categories are being phased out, which will be discussed in this article.

 

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