FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling referred to as the “Pregnancy and Lactation Labeling Rule. Other regulatory authorities also seek this type of analysis in terms of updating the label documents from a pregnancy, breastfeeding, and lactation perspective
PLLR is an analytic tool for evaluating safety data concerning Reproductive, Pregnancy, and lactation risk sections. This evaluation will then help comprehensively present the data on product labels so that the HCP understands the risk quickly and makes clinical decisions based on the same.
This section in the label will also allow consumers and patients to make informed decisions for themselves and their children.
Once the evaluation of PLLR is submitted to the FDA, the label needs to be updated as per the current section requirements. The FDA will approve it, and consequently, it will be added to the labels.
2. Where is it required:
For a product label USPI, SmPC (e.g. addition to label or labeling update), patient leaflets.
If there are additional risk minimization measures for pregnancy and lactation, then adding to the Dear Health Care Professional letter
3. Regulatory background :
The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the "Pregnancy," "Labor and delivery," and "Nursing mothers" subsections of the "Use in Specific Populations" section of the labeling for human prescription drug and biological products. The final rule requires the removal of pregnancy categories A, B, C, D, and X from all human prescription drugs and biological product labeling. For human prescription drugs and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the "Labor and delivery" subsection because information about labor and delivery is included in the "Pregnancy" subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential
4. What are data points utilized to write PLLR
- Global Safety database
- Literature search
- Clinical data
- USPI- current
5. Why and how is it prepared
1.
Review and summary of the available
published literature regarding the drug’s use in pregnant and lactating women
and the effects of the drug on male and female fertility
2.
A cumulative review and summary of
relevant cases reported in the pharmacovigilance database from the time of
product development to the present
3.
A summary of drug utilization rates
amongst females of reproductive potential (e.g. aged 15-50 years) calculated
cumulatively since initial approval
4.
An interim or final report of an ongoing
or closed pregnancy registry (if applicable), pregnancy cases from clinical trials
Based on the above results, each section is drafted, and then a conclusion is reached regarding the risks the product carries when used in pregnant, lactating, or reproductive-age females.
Written by:
Dr.Shraddha Bhange.
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