The FDA recently announced plans to implement new pharmaceutical labelling guidelines over the next several years that will require drug labels to more fully address potential effects on mothers, unborn babies and breastfed infants, as well as the drug’s implications for men and women of reproductive age. This more comprehensive labeling scheme will replace the former protocol under which medications were labeled with letter ratings to indicate the level of risk to pregnant women, but without any additional information. The new guidelines will allow doctors and patients to make more informed decisions about medication use before, during, and after pregnancy.
For pharmaceutical companies, compliance with the new rules will require a good deal of work in order to update and change labels to contain all of the newly required information. The clarity these new labels will provide, however, will likely be beneficial to manufacturers and consumers alike. According to the FDA, pregnant women take an average of three to five medications per pregnancy, including medications that are introduced during pregnancy as well as medications that were taken before pregnancy and continued. Without comprehensive information about both the potential benefits and the potential adverse effects of a medication a woman is considering, many women are left to blindly navigate the pitfalls of either taking drugs that pose an unnecessary risk of harm to themselves or their babies, or of foregoing needed treatments due to lack of reassurance. Not only does this mean that many women are not receiving optimized care, but it also means that pharmaceutical companies stand to miss out on reaching a segment of their target consumer population. Not only that, but companies may face situations where their drugs could be misused in a way that leads to injury and potential liability.
The new labelling scheme can’t entirely eliminate the possibility that some pregnant and nursing women may still choose to avoid certain medications out of fear, despite information that suggests the benefits far outweigh the risks, while others may choose to take medications that are not needed despite even serious risks. But, the new labels will ensure that women are making the choices that are right for them as individuals, after having the opportunity to understand the potential consequences of their decisions and to seek informed guidance from their doctors. The guidelines will also ensure that manufacturers both uncover and disclose critical information about their products’ use among new mothers, providing pharmaceutical companies with an opportunity to even more effectively serve the needs of this population as well as provide appropriate warnings. We will continue to monitor activity in this area as it develops.