AAFP Teams With FDA on Pregnancy, Lactation Labeling Rule Video

June 14, 2016 01:28 pm Chris Crawford

The AAFP and the FDA have released a video to highlight changes in the 2015 Pregnancy and Lactation Labeling Rule (PLLR)(s3.amazonaws.com) that family physicians who prescribe medications for pregnant women and nursing mothers need to know about.

[Pregnant woman reading pill bottle label]

In the updated PLLR, formatting standards for prescription labeling have been modified (including the removal of pregnancy letter categories A, B, C, D and X on drug labels and the addition of risk-based information) to help physicians better counsel pregnant women and nursing mothers.

AAFP member and breastfeeding advocate Anne Montgomery, M.D., M.B.A., of La Quinta, Calif., represented the Academy in the video. She appears along with Lynne Yao, M.D., director of the pediatric and maternal health division, and Rea Blakey, health communications lead, both in the FDA's Center for Drug Evaluation and Research's Office of New Drugs.

Montgomery told AAFP News those involved in the collaboration chose to deliver this message in a video to make it more "eye-catching" and easier to digest for family physicians than a traditional email.

Story highlights
  • The AAFP and the FDA have released a video to highlight changes in the 2015 Pregnancy and Lactation Labeling Rule (PLLR) that family physicians who prescribe medications for pregnant women and nursing mothers need to know.
  • In the updated PLLR, formatting standards for prescription labeling have been modified (including the removal of pregnancy letter categories A, B, C, D and X on drug labels) to help physicians better counsel pregnant women and nursing mothers.
  • AAFP member and breastfeeding advocate Anne Montgomery, M.D., M.B.A., of La Quinta, Calif., represented the Academy in the video.

As to the actual PLLR changes, she said, "The FDA has changed from its old A-B-C-D-X system for pregnancy risk to a more explicit discussion of risks of each drug. They felt the letter categories were too simplistic, and we needed better information to make these decisions.

"They also included information about lactation where available and about considerations for men and women of childbearing potential."

Montgomery said family physicians need to understand that they still need to read the brief drug risk information on labels, but the letter categories will no longer be there. "This should help family physicians make better decisions about use of drugs for pregnant and breastfeeding mothers," she said.

Further Explanation of Labeling Rule

The "Pregnancy" subsection of the drug labeling rule includes information on pregnancy exposure registries(www.fda.gov) that collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women. Drug manufacturers are now required to include information about these registries in their prescription labeling.

This subsection also includes a risk summary, clinical considerations and the information that was formerly found in the "Labor and delivery" subsection.

The "Nursing mothers" subsection was renamed the "Lactation" subsection and provides information about using a drug while breastfeeding, such as the amount of drug in breastmilk and potential effects on the breastfed infant.

The "Females and Males of Reproductive Potential" subsection is new to required drug labeling and includes information, as appropriate, on the need for pregnancy testing, contraception recommendations and information on infertility related to the drug.

These labeling changes took effect on June 30, 2015. Prescription drugs and biologic products submitted for approval after that date will use this new labeling format. Those approved between June 30, 2001, and June 30, 2015, will be phased in gradually.

OTC drugs are not covered in the final labeling rule.

Other AAFP Breastfeeding Resources

As for additional resources on breastfeeding, said Montgomery, "The AAFP has a thorough breastfeeding position paper and also has a set of resources for physicians to use when caring for breastfeeding mothers and babies."

Among the materials available are

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