How the FDA Pregnancy Labeling Rule Affects Patients

Posted February 20, 2015 by admin

Recently, the American College of Obstetricians and Gynecologists (ACOG) released a statement concerning the FDA’s updated product labeling for pregnant users. The changes were widely applauded as an advancement for women’s health but, before diving into the specifics, it is important to know exactly what’s new.

The Pregnancy and Lactation Rule

The Pregnancy and Lactation Rule, or PLLR (sometimes called "the final rule"), required new changes to the labeling of prescription drugs where pregnancies are concerned. The most important changes were to prescription drug labeling sections 8.1-8.3. Previously, 8.1 and 8.2 were the sections on "Pregnancy" and "Labor and Delivery," respectively. Now, the PLLR has combined these previously independent sections into the new and revised 8.1, entitled "Pregnancy," with a smaller font highlighting that it "includes Labor and Delivery."

The final rule of PLLR added a novel 8.2 to replace the 8.2 section that was lumped into the new 8.1 section. This section is entitled "Lactation" with a smaller font noting that this "includes Nursing Mothers." The new 8.2 functionally replaced the old 8.3, which was simply entitled "Nursing Mothers." Now, 8.2 specifically deals with all matters of lactation, including nursing mothers.

As such, the PLLR’s 8.3 is an entirely novel section and it is entitled "Females and Males of Reproductive Potential." According to the FDA, this labeling requirement includes information about pregnancy tests, infertility, contraception, and other pertinent information that assists health providers.

Practical Effects of Pregnancy Labeling Rule

The practical effects of this change is that there must now be information on prescription labels with regards to pregnancy and lactation. As such, health providers will be able to provide more accurate and proper care for pregnant patients. Additionally, health professionals will be more prepared when prescribing medication to mothers. Their hope is that medication will be less likely to harm the child and mother during the pregnancy. This is a step in the right direction, given that more information helps healthcare professionals and their patients.

These labeling changes will go into effect June 30, 2015 and ACOG expresses optimism that they will be a positive step for women’s health in the pharmaceutical industry.

ACOG Statement

ACOG correctly hailed these changes as a beneficial improvement for physicians and health providers. ACOG believes that the changes will assist physicians in providing better medical care and being able to more closely monitor the effects prescriptions have on pregnant patients.

ACOG did stress, however, that the new rule will be reviewed in detail prior to going into effect, allowing physicians to develop educational resources, as needed. An OBGYN seminar, for example, can be particularly helpful for spreading the knowledge of these changes and is important to keep in mind when preparing for the OBGYN board review. Whether you are prepping for the OBGYN board review or want to attend our OBGYN seminar, there are plenty of reasons for you to be optimistic about these changes as a medical professional.