FDA’s Pregnancy and Lactation Labeling Final Rule

Pregnant women and their physicians require the latest information on the impact of prescription drugs on the well-being of mother and child. Women’s health has received additional support with the recent ruling by the Food and Drug Administration. Directed toward product labeling for pregnant and lactating mothers, it amends prior rulings and provides additional information. In his recent statement, John C. Jennings, M.D., president of the American College of Obstetricians and Gynecologists, throws his support behind this recent development.

The Pregnancy and Lactation Labeling Rule goes into effect on June 30, 2015. There are a number of changes to product labeling associated with the ruling. Some are immediate while others will be phased in gradually. These changes to labeling will assist physicians in helping clients make the best choices possible when assessing the benefits and risks as they apply to pregnant, lactating, or possibly pregnant patients.

Changes in Effect Now

According to the PLLR, pregnancy letter categories are removed, and labels are to be updated with the most current information. The Prescription Drug Labeling Sections 8.1-8.3 Use In Specific Populations will change. Section 8.1 Pregnancy now includes labor and delivery. Section 8.2 Lactation includes nursing mothers, and a new category is introduced that will comprise Section 8.3, Females and Males of Reproductive Potential. This new section offers information about pregnancy testing, contraception recommendations and any drug interactions as they relate to infertility. Biological products and prescription drugs submitted after June 30, 2015, will immediately implement the new format. Labeling for over-the-counter medications will not change.

Future Changes

The pregnancy subsection will include information for a pregnancy exposure registry when it is available. This registry will contain data on the effects of approved drugs on this population. Information about the existence of the registry will be required. Biological products and prescription drugs approved by or after June 30, 2001, will be gradually phased in.

Maternal-fetal medicine will be positively affected by the new developments in prescription drug labeling. A new subcategory of patients wanting to conceive will get additional support with implementation of the PLLR. Providers will have to maintain vigilance with regard to the new systems being put into place on June 30 and those that will be introduced or expanded at a later date, such as the registry and the changing labels on more established medications. Using the resources of Perinatal Resources, Inc. is one way to stay abreast of recent developments in this field.

Perinatal Resources, Inc. is a nonprofit organization offering live conferences and webinars for OBGYN board review. An industry leader, the organization’s experts help to educate new and continuing obstetricians and gynecologists on the most recent developments in the field. Contact Perinatal Resources, Inc. to pass the OBGYN board review or to enhance your knowledge.