On February 19th, 2010, FDA published a proposed rule in the Federal Register to revise 21 CFR §§ 16, 58, 71, 101, 171, 190, 312, 511, 571 and 812 to require Sponsors of the various impacted regulatory applications to file a report with FDA providing specific information when someone “has or may have (emphasis added) engaged in the falsification of data. More specifically, “FDA is seeking information on falsification of data by any person involved in studies conducted by or on behalf of a sponsor or relied on by a sponsor.” Thus, under the regulation, you wouldn’t need to have anything at all to do with a study to incur the responsibility other than relying on it, as you do for a 505(b)(2). Further, under the proposed regulation, the Sponsor doesn’t have a lot of options: “This reporting obligation would exist regardless of the amount of evidence, if any; (emphasis added) the sponsor has with regard to the intent of the person who has, or may have, falsified data.”
This is a fairly onerous proposal, with potentially devastating consequences for a large number of people. FDA must be providing some pretty clear guidance on what would trigger a report, right? Unfortunately, the answer is ‘no’.
“We (FDA) purposely are not proposing to specify in the regulations any particular information threshold that must be met before the reporting requirements are triggered, such as the exact form, quantity, or reliability of information about possible falsification that would require a sponsor to report to FDA. We do not believe it is possible to codify all forms of information on possible qualification (some examples provided)…or specify a quantity of information that would constitute a minimum threshold for sponsor reporting, and we do not inadvertently exclude information that, upon further investigation by the Agency, could help uncover falsification.”
The justification for giving no standard is the Agency’s apparent lack of confidence in its ability to provide a perfect standard.
In this regard, there is at least a possibility for improvement: “…we invite comment on whether the regulation should specify some form of evidentiary standard or minimum threshold, such as what form(s) or quantity of information is needed to create a requirement to report and, if so, what the standard should be.”
Camargo recommends comments – lots of comments, because there are potential consequences under the proposed rule for failure to report confirmed or possible falsification.
“Failure to report possible falsification of data might constitute a violation of Section 301(e) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 331(e)) (concerning failure to make a required report) or 18 U.S.C. 1001 (concerning the submission of a false statement to the Federal government).”
Thus, worst case, Sponsors (employees?) could be looking at fines or even imprisonment for failing to report something which may or may not have taken place under a regulation without a set standard for reporting it. This one needs a lot of work. The potential for both abuse and unintended consequences under the regulation as written is extremely high. 21 CFR §1301.91, regarding employee responsibility to report (controlled) drug diversion might be a good place to start.