Package Inserts (PIs)
Regulated by the FDA
The Food and Drug Administration’s criteria for drug information is based on scientific accuracy presented without bias. Drug manufacturers are held to a high standard when the FDA reviews their Labeling Content, the written contents of the Package Insert. The FDA has provided manufacturers clear directions not only on the content required, but also on format, including legibility, readability, and limits on type size.
When the FDA approves a drug for “launch,” the labeling copy is usually the last element approved. The FDA is not a rubber stamp in these negotiations, which are private. Many launches have been delayed because the FDA and the manufacturer could not agree on the wording of warnings, precautions, or claims.
Reliable and readily available
The existing system of printed Package Inserts (PIs) thus offers unbiased scientific information throughout the entire drug supply chain. The Package Insert is the primary source of reliable, scientific information for healthcare professionals as “learned intermediaries” to patients, or for the involved patient or caregiver who reads the Package Insert for their own benefit.
Benefiting healthcare professionals
The printed literature designs that developed and evolved in response to the 1938 Food, Drug and Cosmetic Act were effectively delivering essential medication information to patients and health care providers when, following a six-year period of study, the FDA published a set of new requirements for Package Inserts in 2006.
As the FDA noted, “In recent years, there has been an increase in the length, detail, and complexity of prescription drug labeling, making it harder for health care practitioners to find specific information.”
The FDA’s cost / benefit analysis of the net savings was compelling: almost half a billion dollars saved from avoiding adverse drug events and saving practitioners’ time, balanced against minor costs for printing and designing to the new format.
One of the key elements of the final rule was to require a highlights section. The FDA also specified how small type could be, particularly for information intended for patients such as Medication Guides or Patient Package Inserts (PPIs).
As a result of this action, printed packaging suppliers to the pharmaceutical industry made substantial investments in order to achieve full compliance in a timely manner. Those printers, while not regulated directly by the FDA, practice the same current Good Manufacturing Practices (cGMPs) that the FDA requires of drug producers.