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.
79 Fed. Reg. at 75511. The proposed rule is silent about whether the FDA’s website would track “hits” and more specifically their source, but there’s no technical reason that would make such tracking impossible. The FDA’s proposal is likewise silent on how long the Agency could or would preserve tracking information about hits.
In the past, the FDA has sometimes preempted civil discovery. See21 C.F.R. §20.63(f)(2) (preempting civil discovery of identities of persons who file adverse event reports with the Agency). There’s no indication in the current proposal of such preemptive intent. Thus, the FDA should expect to be on the receiving end of a host of third-party ediscovery requests (we doubt the FOIA would apply to requests for such individualized information) for when Dr. X accessed the repository for information about Drug Y. Such requests could come from either the plaintiff or defense side.
Another ediscovery front also suggests itself. If the Agency proves obstreperous (or preemptive), then litigants could direct similar ediscovery at the prescribers themselves. Their computer systems may track when Doctor X accessed the FDA repository for information about Drug Y.
For once, we’re talking about ediscovery directed to persons other than our clients.
Whoops, that’s not entirely true. The FDA’s backup plan, for situations where internet access is questionable, is for manufacturer-operated 24-hour telephone hotlines:
Under proposed §201.100(c)(5), the manufacturer or applicant would be required to ensure that the toll-free telephone number is current, fully functioning, and maintained so that there is always an alternate method to obtain the current prescribing information if the requestor cannot access the FDA’s labeling repository Web site. The toll-free telephone number service would be required to be available 24 hours a day, 7 days a week.
79 Fed. Reg. at 75515. Just as with the FDA-run repository, the FDA’s proposal is silent about whether toll-free number operators would be required to keep physician- and drug-specific contact information, and if so for how long.
The FDA obviously hasn’t given civil litigation the slightest thought in formulating the current proposal. The words “litigation” and “discovery” (or any variants) do not appear anywhere in the Federal Register announcement. It would probably be a good idea if somebody required it to consider the issue. The comment period for the proposed rule closes on March 18, 2015.