By David Charles, MD and Mary Ann Chapman, PhD
Every prescription medication approved in the United States is accompanied by a printed document for physicians called the prescribing information. The prescribing information is also known as the package insert or product label—not to be confused with the box or paper affixed to a medication bottle that simply states the product’s name. Prescribing information is designed to give physicians the details they need to make prescribing decisions for patients. For each medication, the prescribing information follows a standardized, indexed format developed by the US Food and Drug Administration (FDA). Every word in the prescribing information is subject to intense scrutiny and is approved by the FDA.
Historically, each prescription medication was accompanied by specific and unique prescribing information. In the 1980s, the government passed a law allowing generic drugs to use the same prescribing information as the original medication. This law applied to conventional drugs—medications that are chemically synthesized.
In March of 2015, the FDA approved the nation’s first biosimilar. Biosimilars are biological medications (biologics) that are similar but not identical to the original product; they are not generics. Despite the inherent differences between
biologics, prescribing information for the first biosimilar was entirely based on the prescribing information of the original medication. This is a questionable approach because even minor differences in biologics can lead to unexpected safety issues,1 and physicians need complete and specific information about medications they prescribe.