PMEL

Pregnancy and Lactation Labeling Rule (PLLR)

The Pregnancy and Lactation Labeling Rule (PLLR), also known as the "Final Rule," is a regulation issued by the United States Food and Drug Administration (FDA) that requires changes to the content and format of prescription drug labeling to assist healthcare providers in assessing the benefits and risks of drug use during pregnancy and lactation. The rule aims to provide clearer information to help healthcare professionals make informed prescribing decisions and counsel women about the use of medications during pregnancy and breastfeeding.

Background

Prior to the implementation of the PLLR, drug labeling included a five-letter system (A, B, C, D, and X) to categorize the potential risks of drug use during pregnancy. This system was often criticized for being overly simplistic and not providing enough detailed information. The PLLR was introduced to replace this system with a more comprehensive and informative approach.

Implementation

The PLLR was published on December 4, 2014, and became effective on June 30, 2015. It applies to all prescription drugs and biological products submitted for approval after June 30, 2001. The rule requires that the labeling for these products include a summary of the risks of using the drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help healthcare providers make prescribing decisions.

Labeling Requirements

The PLLR requires the following sections to be included in the labeling of prescription drugs:

1. Pregnancy

This section includes information about the potential risks of using the drug during pregnancy, including:

• A risk summary that describes the potential effects of the drug on the fetus.
• Clinical considerations that provide information on disease-associated maternal and/or fetal risk, dose adjustments during pregnancy, and potential adverse reactions.
• A data section that summarizes the available data on the use of the drug in pregnant women.

2. Lactation

This section provides information on the use of the drug during breastfeeding, including:

• A risk summary that describes the potential effects of the drug on the breastfed child.
• Clinical considerations that provide information on minimizing exposure to the breastfed child and potential adverse reactions.
• A data section that summarizes the available data on the use of the drug during lactation.

3. Females and Males of Reproductive Potential

This section includes information on the need for pregnancy testing, contraception recommendations, and information about infertility as it relates to the drug.

Impact

The PLLR has been instrumental in improving the quality of information available to healthcare providers and patients regarding the use of medications during pregnancy and lactation. By providing more detailed and structured information, the PLLR helps to facilitate better clinical decision-making and patient counseling.

Criticism and Challenges

While the PLLR has been praised for its comprehensive approach, it has also faced criticism. Some healthcare providers have noted that the increased amount of information can be overwhelming and may require additional time to interpret. Additionally, the availability of data on drug use during pregnancy and lactation is often limited, which can make it challenging to provide definitive guidance.

Also see

• Food and Drug Administration
• Drug Safety
• Pregnancy Category
• Lactation
• Clinical Pharmacology