Questions and Answers on the Pregnancy and Lactation Labeling Rule

Government
Questions and Answers on the Pregnancy and Lactation Labeling Rule
By FDA
May 28, 2008 - 5:15:42 PM

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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.

The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides when such labeling is approved for a prescription drug.

The proposed rule outlines what important information about the use of medicines during pregnancy and breast-feeding would be required to be added to product labeling for newly approved drugs. Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.

The proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling. The newly designed format, for the pregnancy section of the labeling would have three sections:

The first section, called the "Fetal Risk Summary," would describe what is known about the effects of the drug on the fetus, and if there is a risk, whether this risk is based on information from animals or humans. The proposal calls for a risk conclusion based on the available data and provides a number of examples depending on the quality and quantity of that data. For example, one risk conclusion might be: "Human data indicate that (name of drug) increases the risk of cardiac abnormalities." This would be followed by a summary of the most important data on the drug’s effects.
Another section, called "Clinical Considerations," would include information about the effects of the use of the drug if it is taken before a woman knows she is pregnant. This section also would feature discussions about the risks of the disease to the mother and the baby, dosing information, and tell how to address complications.
The third section, under the heading "Data," would describe in more detail the available data regarding use of the drug in humans and from animal studies that were used to develop the Fetal Risk Summary.

The pregnancy section would also include information about whether there is a pregnancy exposure registry for the drug. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women.

The lactation (breastfeeding) section of prescription drug labeling would use the same format as the pregnancy section. The lactation section would provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling for previously approved drugs will be phased in gradually under FDA’s recent Physician Labeling Rulemaking.

Electronic comments can be submitted within 90 days via the Federal Documents Management System/eRulemaking portal at www.regulations.gov. The FDA will carefully consider the comments in preparing a final rule.

For more information, visit: http://www.fda.gov/cder /regulatory/pregnancy_labeling /default.htm

1. What is FDA announcing today?

FDA is proposing major revisions to prescription drug labeling concerning drug use during pregnancy and breast-feeding. FDA’s proposed rule would require more complete information about the use of drug and biologic products by women of childbearing age, pregnant women, and women who choose to breast-feed.

2. What are the major changes that are being proposed?

Today’s proposed revisions to prescription drug labeling represent a major milestone, because the new labeling would provide available scientific data and information - in a clear and accessible format - about the use of drugs by pregnant and nursing women. The new labeling format will include a risk summary and information about available data on use of the drug during pregnancy and while breastfeeding, to help health care providers counsel pregnant women, nursing women, and all women of reproductive age about the use of prescription drugs and biologics.

Among the major changes will be the elimination of the letter category system, which frequently has been criticized as misleading and overly simplistic. The proposed new labeling format will be based on the most relevant scientific data available, and will provide information specifically intended to address the special health needs of pregnant and nursing women.

3. What drugs will be affected by this rule?

The revised pregnancy and lactation formats would be used for drugs approved after the final rule becomes effective, as well as for previously approved drugs that are subject to the FDA’s recent physician labeling rulemaking. For those previously approved drugs subject to the physician labeling rulemaking, the revised formats would be implemented over a period of years. In addition, the current system of letter categories relating to use of the drug in pregnant women would be eliminated from the labeling of all approved drugs.

4. What is FDA's goal for the new labeling format?

FDA’s goal is to give health care providers better information about the use of prescription drugs during pregnancy and breast-feeding. We believe that better information will help healthcare practitioners, in consultation with their patients, make more informed choices about which drugs to prescribe during pregnancy and breast-feeding. The more detailed information that this labeling will ultimately provide should also help health care providers counsel women who took a drug before they knew they were pregnant.

5. How would this proposed rule benefit women who are pregnant or breast-feeding?

Prescription drug labeling is written for doctors and other healthcare practitioners, who use the information to counsel and advise their patients about which drugs to use. In consultation with their healthcare practitioners, women may use this information to make important decisions about medicine use during pregnancy and while breast-feeding, as well as more generally during their child-bearing years, with the possibility that they may become pregnant in the future. In situations when a woman becomes pregnant unexpectedly, the more detailed labeling information that would be required by the proposed rule would help healthcare practitioners explain what is known about the possible effects of a drug on an early pregnancy. For women who need to continue a medicine or start a medicine while breastfeeding, this information would help a woman and her baby’s pediatrician determine the possible effects of the medicine on the baby and whether it would be better for the baby’s health overall to breast-feed or to formula feed.

6. Where will the data in the prescribing information come from?

The data could come from various sources, including studies published in the medical literature about the use of prescription drugs during pregnancy and breast-feeding. Companies would be required to include clinically relevant information from such published studies in the labeling. Another source of data could be from pregnancy exposure registries, which are conducted by some companies to collect information on the effects of their approved drugs when those drugs are used by pregnant women to treat a medical condition

7. What is a pregnancy exposure registry?

Pregnancy exposure registries are studies that collect and maintain data on the effects of drugs and vaccines that are used by pregnant women. These registries do not require women to take an experimental drug or a drug they would not ordinarily take. Instead, the registries collect information on the effects of already approved drugs prescribed to pregnant women by their doctors. FDA encourages drug companies to maintain pregnancy exposure registries, and has issued a guidance advising drug manufacturers how to conduct a pregnancy exposure registry. http://www.fda.gov/cder/guidance/3626fnl.htm

8. Does the proposed labeling format include information on pregnancy exposure registries?

Yes, under the proposed rule, the pregnancy subsection of the labeling would be required to include information on any pregnancy registry that had been established for the drug.

9. Where can I learn more about pregnancy exposure registries?

If you are pregnant and want to know more about participating in a pregnancy exposure registry, visit the Office of Women’s Health website at: http://www.fda.gov/womens/registries/default.htm. This page includes a list of all active pregnancy exposure registries. Women can enroll themselves in many cases, but in some cases they may have to work with a health care professional to enroll.

10. What are some of the major concerns in treating pregnant women who have chronic diseases or pregnant women who need immediate treatment for an acute condition?

Frequently, women with chronic diseases need to take prescription drugs to manage their medical problems, and they may need to continue taking those drugs when they are pregnant. Pregnant women can develop acute medical problems that require immediate treatment, such as kidney infections, upper respiratory infections, gastro-esophageal reflux (GERD), and other conditions, just like individuals who are not pregnant. Pregnant women also can develop problems directly related to their pregnancy, such as severe nausea and vomiting, gestational diabetes or pregnancy-induced hypertension (high blood pressure). These medical problems often require treatment with prescription drugs.

The major challenge when treating pregnant women is one of balance – a balance between possible harms and benefits to both the mother and fetus (developing baby). Although using a prescription drug may pose a risk to the pregnant woman and her fetus, there can also be risks associated with not treating an illness. Using a prescription drug to treat an illness can offer benefit by preventing the harm caused by the illness itself.

Frequently, there is little information available about the effects of using a prescription drug during pregnancy or while breast-feeding, and what information there is often becomes available only after a product is approved and marketed. It is often scattered in the medical literature and does not get incorporated in labeling. The proposed rule would address this by requiring that available information about the effects of a drug on pregnancy and lactation be actively sought and, when appropriate, be included in the labeling, in a revised format that would make that information more useful to healthcare practitioners and their patients. In addition, the labeling would specifically state when there is not information available.

11. What progress has FDA made recently in updating drug labeling with information on the use of drugs in pregnancy?

In recent years FDA has been working to develop more comprehensive information about pregnancy in labels for individual drugs as important studies have appeared in the literature. For example, in 2001, when letters containing anthrax spores were mailed to Congressional and news media offices, the Centers for Disease Control and Prevention recommended the use of doxycycline, ciprofloxacin, and amoxicillin for treatment or prophylaxis following anthrax exposure. FDA received large numbers of questions about the safety of prescribing these drugs to pregnant women. FDA staff searched the published medical literature for information on the use of these drugs during pregnancy and provided that information to the public on FDA's website. Eventually, the companies that make these three drugs added certain information about the use of the drugs by pregnant women to the labeling for the products. Since that time, FDA has continued to work with companies to include human data about the use of drugs in pregnancy in drug labeling.

12. When will this rule take effect?

The version of the rule being published today is only a proposal. FDA expects to receive numerous comments on the proposed rule, and those comments will need to be considered carefully before we publish a final rule. This process will take some time.