An article in STAT (here) (paid subscription required), authored by a former FDAer, Jane Axelrad, should be read by all in the pharmaceutical industry. Axelrad notes that, while online access to current prescribing information has been available for over fifteen years, progress in eliminating the requirement to provide paper labels has been stymied by paper manufacturers and firms that print and fold these mostly unused documents.
Axelrad says, “because paper prescribing information is often out of date, by months if not years, it may lack the most recent warnings or contraindications necessary for safe use of the drug” by the time anyone reads the paper label. Which is true, not because the generic and brand-name companies are slow in updating their labels, but more because drug products typically have expiration dates of two to five years. If a product’s burn rate is slow, then it is possible that by the time the last product is being dispensed, the paper package insert accompanying it will be anywhere from just under two-years old to almost five-years old and will not have any of the changes that were required since the product was initially packaged.
In addition to the theory outlined above, think of the cost savings. No need to purchase, package, and track paper versions through the manufacturing process. Required updates to electronic labeling can be made in a matter of minutes by firms and made readily available to healthcare practitioners and the general public almost instantaneously. Possibly, with the current political pressure on drug product prices, the shift to electronic labeling could be a tool for lowering prescription drug prices too. Maybe it is time to enter into negotiations with the industry for a quid pro quo. That is, we (Congress) will remove the requirement for paper labeling if you (the manufacturers) will pass the savings on to customers. In response to the outdated argument that labeling might otherwise be unavailable to those who live in rural or remote areas, just provide copies to healthcare practitioners or patients who request a paper copy, as Axelrad suggests. Good job, Ms. Axelrad, for trying to put this issue front and center!
