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Pregnancy and Lactation Labeling Gets a Face Lift

March 17, 2015 | Mark A. Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs

Since implementation of the Physician Labeling Rule (PLR) back in 2006, the FDA has been working to improve the content and format of prescription drug labeling. The most recent improvement comes with the issuing of a final rule, as well as a draft guidance document, on pregnancy and lactation labeling.

If you are planning an NDA or BLA submission, or have one currently under review, you need to be aware of these changes!

Click here for FDA labeling guidance documents
The Physician Labeling Rule (PLR) profoundly changed the nature of prescription drug labeling (the “Package Insert”).From the addition of the “Highlights Section” to the distribution of information in newly ordered sections, the PLR’s goal was to make information in prescription drug labeling easier for healthcare professional to access, read, and use in making prescribing decisions.

Several guidance documents have been issued over the years, which address the content and format of specific labeling sections (eg, Dosage and Administration, Warnings & Precautions, Adverse Reactions, Clinical Studies).

Now the FDA has issued a new rule, dubbed the “Pregnancy and Lactation Labeling Rule” (PLLR), which sets new standards for how information about using medicinal products during pregnancy and breastfeeding is to be presented in product labeling.

Note that this is a rule (regulation), and actually revises the PLR content and format requirements for those sections under “Use in Specific Populations,” which talk about pregnancy, lactation, and reproductive potential.

An accompanying guidance document (still draft at the time of this writing) has also been issued.

Pregnancy Categories Phased Out
If you had a hard time remembering what “Pregnancy Category B” meant and how it differed from “Pregnancy Category C,” you’ll be happy to hear that these classifications will no longer be used.
What’s Taking Their Place?
Instead, the PLLR calls for specific, structured content under three labeling subheadings:

  • 8.1 Pregnancy,
  • 8.2 Lactation, and
  • 8.3 Females and Males of Reproductive Potential.

The last subheading (8.3) is new, and is meant to contain contraception and/or pregnancy testing recommendations (if appropriate), as well as any human or animal data suggesting effects on fertility.


Timeline for Compliance
The pregnancy and lactation labeling rule becomes effective as of June 30, 2015.

After that date, labeling for any newly approved drugs or biologic products will need to be in the new format. This includes products currently under review that will be approved after June 30th.

So if you’re in that situation, you should be updating the proposed labeling in your submission now!

For products approved between June 30, 2001 and the PLLR effective date of June 30, 2015, there is a staged approach to when conversion to the new format is required (call us if you want to discuss your particular situation).

For products approved prior to June 30, 2001, even if your product is not subject to the PLR at all, you still must remove the pregnancy category from your product’s labeling by June 30, 2018 (yes, you have 3 years to accomplish this task).

Need Help?
IMPACT’s regulatory affairs professionals are thoroughly versed in all PLR requirements and guidance documents and can assist your product development teams with drafting new product labeling or updating your current product labeling to be PLR-compliant.

Please contact us or give IMPACT a call today at (919) 899-9248 to discuss your specific needs.

Category: Regulatory Affairs
Keywords: labeling, pregnancy, lactation, PLR, PLLR

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