Pharmaceutical manufacturers and distributors are under an obligation to ensure the public is protected and well-informed. But considering that an estimated 7,000 Americans die each year due to inappropriately dispensed drugs, it’s clear that some makers are falling short. And for some of the nation’s most vulnerable consumers, the importance of public safety becomes even more apparent.

That’s just one reason why the FDA created new regulations in 2015 that aim to protect pregnant women, women who are breastfeeding their children, and all consumers who are of reproductive age. These rules outline how drug manufacturers need to inform pharmacists and physicians about certain medication risks; in so doing, the FDA did away an older system of how risks were categorized, which was found to be confusing to both medical professionals and consumers. Instead of continuing with an unnecessarily vague system, the FDA opted to overhaul required labeling designs for pharmaceuticals to prioritize the health and safety of expectant mothers, nursing mothers, and individuals who may bear children.

Prescription medications submitted to the FDA after June 30, 2015 were required to follow these new regulations, while prescription medications approved after 2001 would be updated gradually. Non-prescription medications are not subject to the same rules. However, prescription pharmaceutical labeling information can fall under categories for pregnancy (which includes delivery and labor), lactation (including nursing mothers), and all people of reproductive age. Medication information on pharmaceutical label designs pertaining to pregnant women needs to include any known risks of miscarriage or birth defects, which can allow physicians to consider these risks prior to issuing a prescription. Pharmaceutical labeling requirements also state that medications include information about possible effects on infants who are breastfed, as well as the amount of drug that may be present within breastmilk as a result of taking a given product. Finally, prescription medications are also now required to provide information about whether a consumer (and/or their partner) will need to refrain from becoming pregnant before, during, or after taking a given medication, as well as whether a pregnancy test should be taken. If medication might affect a consumer’s ability to become pregnant, the label design must include this information, as well.

Keep in mind that the FDA made these adjustments for good reason. According to a clinical resource published in Women’s Healthcare, anywhere between 64% and 94% of pregnant women use prescription medications during their pregnancies. What’s more, 80% of pregnant women who take prescription medications do so during their first trimester, which can have major impacts on the growing fetus. And because many women are managing chronic illnesses, refraining from prescription drug use during or after pregnancy may simply not be possible. Rather than take issue with expectant and new mothers for taking the medications they need, the FDA decided that offering improved information to medical providers would be the most effective course of action.

Ultimately, that means that prescription drug manufacturers have to take these specific consumers into account when creating new label designs and packaging information. Reputable pharmaceutical labeling companies are up-to-date on necessary regulations and can help to ensure compliance for these manufacturers. Proper categorization and information exchange is essential to prioritize public safety and consumer trust. To learn more about specific regulations pertaining to your pharmaceutical products or how to improve your existing labeling methods, please contact us today.