By: RADM (Ret.) Sandra L. Kweder, M.D., F.A.C.P.
Good news for moms and expecting moms across the country. We have a new way of helping health care professionals and patients better understand the effects of medicines used during breastfeeding and pregnancy.
Today, after years of careful consideration — and listening to public feedback — FDA has published a final rule that sets standards for providing a consistent way for drug manufacturers to provide information about the risks and benefits of prescription drug and biological products used during pregnancy and lactation (the medical term for producing milk). It also includes requirements for ways of communicating relevant information for women and men of reproductive potential.
The new rule eliminates an old and possibly confusing way of communicating risk during pregnancy and breastfeeding, which used letter categories of A, B, C, D, and X, to classify various types of risks. It may look simple, but this system was anything but. As a result, the letter categories that have been a familiar presence in drug labeling since the 1970s were often misinterpreted as a sort of grading system of risks, which gave an overly simplified view of product risks.
Our new method provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus, the breastfeeding child, and women and men of reproductive age.
Here’s a quick overview: Prescribing information for health care professionals provided by manufacturers will now contain required subheadings within the Pregnancy and Lactation subsections: risk summary, clinical considerations, and data. These subsections will provide more detailed information regarding, for example, human and animal data on the use of the drug, specific adverse reactions and information about dose adjustments needed during the pregnancy and post-partum (after giving birth) periods. It will apply not just to new drugs approved from now on, but also to older drugs approved since 2001 that have been marketed for years without their labeling being updated to incorporate important new information related to pregnancy and lactation.
Also today, FDA is issuing what we call a “draft guidance” for industry, to assist drug manufacturers in including information about pregnancy and lactation in their prescribing information according to the requirements of the new rule. We’ll finalize that draft guidance after receiving and incorporating input from the public. To provide comments on this draft guidance, visit this link.
There are more than 6 million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy, so we’re excited about this rule, which will provide an extra layer of safety and informed decision making for patients and health care professionals.
Protecting pregnant women and children of breastfeeding mothers from adverse reactions from medications and informing patients and health care providers about their benefits is an ongoing effort we must constantly update and advance. This new rule is one of many steps along the way — and we believe it will help make a strong and positive difference in safeguarding the American public.
Sandra L. Kweder, M.D., is the Deputy Director of the Office of New Drugs at FDA’s Center for Drug Evaluation and Research