On December 18, the FDA published its proposed rule for replacing the venerable package insert with “electronic” prescribing information. The cite is 79 Fed. Reg. 75506, and a link to it is here. We’re not regulatory lawyers, so we’ll leave any debate over whether this proposed rule is good or bad to the folks at the FDA Law Blog.
We’re product liability litigators, so when we hear about “electronic” anything, one thing we think about is ediscovery. Currently, with paper package inserts, when we’re taking discovery, all we have is the prescriber’s say so about whether s/he reviewed the insert, and when. Nor do we have any sure way of knowing exactly what version of drug/device labeling the prescriber reviewed. The date of the visit that produced the prescription, when placed against the history of the relevant labeling provides a pretty good idea, but there’s always a chance that the product sat on a shelf somewhere through a label change or two.
If the FDA’s proposal to shift to electronic distribution of the prescribing information that’s now in package inserts takes effect all that could change. The main avenue of distribution envisioned by the FDA would be a “single, comprehensive Web site” − an online “repository” operated by the FDA itself:
The proposed rule would require manufacturers and applicants to distribute electronically prescribing information by submitting the labeling in an electronic format that FDA can process, review, and archive . . . to FDA each time the labeling content is changed. The submitted labeling would be distributed via FDA’s labeling repository Web site (labels.fda.gov), which is a publicly available Web site.