FDA Issues Final Rule on Pregnancy and Lactation Labeling

Rosemary Frei, MSc

February 2015, Vol 5, No 1 - FDA News

The US Food and Drug Administration (FDA) is hoping that its December 4, 2014, final rule on pregnancy and breastfeeding labeling for prescription drugs and biological products1 will be helpful to patients and providers. Clinicians are also optimistic about the changes but are waiting to see whether sufficient data will be available to truly clarify the risks of using each medication during conception, pregnancy, and lactation.

The new regulations state that as of June 30, 2015, labels for newly approved medications must have 3 subsections—Pregnancy, Lactation, and Females and Males of Reproductive Potential—describing the medication’s effects on women who are pregnant or breastfeeding, on the fetus and breast-fed children, and on men and women who are attempting to conceive. Labels must no longer include a labor and delivery subsection or the currently used A, B, C, D, or X pregnancy category designation for classifying teratogenicity.

Over the subsequent 3 to 5 years, products approved from 2001 to June 2015 will be required to comply with the new labeling rules. Labeling for medications approved before June 30, 2001, will not be required to include the new changes, but the letter designation, if any, must be removed within 3 years of the final rule’s effective date.

“We’ve been long aware that this section of the medical product labeling is probably one of the least informative sections of the drug labeling there is. It is rarely up to date, [and] we hear from clinicians that they don’t understand it [and that] there were long descriptions of animal data that were not interpreted well,” Sandy Walsh, FDA Press Officer, stated in an e-mail to Oncology Practice Management. “[A]nd studies…done by astute clinicians and researchers never made it to labeling. We’re hoping this new rule will allow for much more useful information to be added consistently.”

Richard L. Schilsky, MD, Chief Medical Officer, American Society of Clinical Oncology, commended the FDA for moving forward with the changes but said a large data gap remains. “The rule seems to deal with how the information should be presented in the label,” Dr Schilsky told Oncology Practice Management. “[But] the bigger issue is how we get the information that needs to be in those sections of the label that actually provides the guidance that physicians and their patients are looking for. The problem is the lack of information about what the risks of different drugs are to the developing fetus or the child who’s breastfeeding, particularly with some of the new targeting drugs that we don’t have much experience with.”

Urologist Philippe Spiess, MD, gives a passing grade to the changes. “A, B, C, D, and X in the current labeling isn’t very clear to the lay public,” Dr Spiess, who practices at Moffitt Cancer Center, Tampa, FL, said in a telephone interview. “I think the changes will be well-received and will increase the clarity in understanding the labels. But there will be some adjustment on all sides getting used to the new system.”

The final rule stipulates that the Pregnancy subsection of the label will specify whether there is a scientifically acceptable pregnancy-exposure registry for the drug. This subsection also will include a summary of the risks to fetuses and mothers of using the drug during pregnancy, as well as any other available information to help clinicians counsel pregnant women about use of the medication.

The Lactation subsection will indicate whether the medication is absorbed systemically by the mother and, if so, what its effects are on milk production; how much of the drug reaches the breast milk; and what its effects are on breast-fed babies. Other information to be put in this subsection includes ways to minimize the amount of the drug ingested by children via breastfeeding and ways to monitor for and reduce side effects from the medication.

Information in the Females and Males of Reproductive Potential subsection will address whether pregnancy testing or contraception is needed or recommended before, during, or after medication use. Furthermore, if studies have indicated that the medication affects fertility, these data will also be included.

The opportunity for public comments regarding this measure closed on February 1, 2015. The FDA is now planning to finalize draft guidance for the industry.


  1. Federal Register: The Daily Journal of the United States Government. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. https://federalregister.gov/a/2014-28241. Published December 4, 2014. Accessed February 11, 2015.