![]() ![]() PPI also rejected an argument for the statute’s per se inapplicability in “private civil litigation in which FDA is not a party,” finding the statutory language “sufficiently broad to encompass the circumstances at issue” – subsequent “expert” testimony involving a drug that the witness had overseen while at the FDA. at *4 (“it is not clear that regulations interpreting criminal conflict of interest statutes are entitled to deference”). However, the value of these regulations was questionable. Rather it is a specific proceeding affecting legal rights of identified parties. Pproval of a particular drug and its labeling − whether a prescription drug or an OTC version of that drug after consideration of safety and regulatory data regarding the prescription version − is not the promulgation of a rule of general application. Indeed, one of the examples in these regulations involves an FDA official, but was not particularly on-point. “here the bar of section 207(a)(1) applies, a former employee may not serve as an expert witness.” 5 C.F.R. There were, however regulations – which made clear that the statute applies to expert testimony. Neither the parties nor the Special Master have identified any cases applying Section 207 to a former FDA employee who proposes to testify in a product liability lawsuit regarding a prescription drug with the same active ingredient and indications as a later-approved OTC pharmaceutical product that the employee reviewed while at FDA. ![]() Was the witness disabled by §207 from testifying about FDA regulation of a related drug? The expert’s report established “that the review for approval included the review of safety data related to the prescription version of the drug.” Id. The witness had, while working at the FDA, supervised proceedings involving the same molecule that was at issue in PPI and had been engaged by one of the parties. It prohibits: (1) any former “officer or employee … of the executive branch of the United States” – including the FDA – from (2) “knowingly mak, with the intent to influence, any communication to or appearance before any … court,” about something (3) “in which the person participated personally and substantially as such officer or employee,” and which (4) “involved a specific party or specific parties at the time of such participation.” Id. It wasn’t exactly the same drug, but it was close – the OTC version of a prescription drug at issue in the litigation. ![]() The witness was very expert, indeed, on this topic:Īs a Team Leader and the Division Director of FDA’s Division of Nonprescription Clinical Evaluation “was intimately involved with proton-pump inhibitors and the FDA’s approval of for over-the-counter use” and “oversaw the labeling of these drugs, the adequacy of the warnings, and any changes to the labels.” The witness at issue was expected to “offer opinions regarding the regulatory requirements and proceedings with respect to” one of the drugs at issue in the litigation, which had been taken by a particular plaintiff. In PPI such a witness had been retained by one of the defendants, but the same thing likewise could have arisen in connection with a plaintiff-side expert. The problem is that any party, on either side of the “v.,” would prefer to have (budget permitting) the most expertly expert witness possible. at *4 (citation and quotation marks omitted). We have never seen that statute invoked in connection with an ex-FDA witness before, and apparently neither has anyone else, since the opinion observes that “the fact pattern presented here is something of an unprecedented issue.” Id. §207, a federal conflict of interest statute. The ability of an FDA expert witness to testify was challenged under 18 U.S.C. An interesting issue recently arose (but was not resolved) in In re: Proton-Pump Inhibitor Products Liability Litigation, 2022 WL 2188038 (D.N.J. ![]()
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