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PROCEEDINGS BEFORE THE FOOD AND DRUG ADMINISTRATION ARE QUASI-JUDICIAL IN NATURE, STATEMENTS PROTECTED BY ABSOLUTE PRIVILEGE.

The First Department, in a full-fledged opinion by Justice Saxe, over a dissenting opinion, reversing Supreme Court, determined proceedings before the FDA (US Food and Drug Administration) are quasi-judicial in nature and statements made during the proceedings are therefore protected by absolute, not qualified, privilege. The defamation cause of action should have been dismissed:

The statements that form the basis of the defamation claim at issue here were made to a U.S. Food and Drug Administration (FDA) investigator in the course of an investigation. … Given both the nature of an FDA investigation into the propriety of the hospital’s research protocols and the importance of the unimpeded flow of thoughts and information in this investigative context, as a matter of law and public policy, statements to such an investigator must be protected by an absolute privilege, not merely a qualified privilege. * * *

The statements at issue here were made to an FDA investigator looking into accusations that IRB (hospital Institutional Review Board) protocols at NYDH (New York Downtown Hospital) might not be properly handled. The FDA is an administrative agency of the federal government, charged with many responsibilities, including ensuring that new drug trials are handled properly. The complicated regulatory scheme for oversight by the FDA over the operation of IRBs in conducting new drug protocols, controlled by 21 CFR part 56, includes provision for procedures where an FDA investigator observes apparent noncompliance with these regulations in the operation of an IRB. Under these regulations, the IRB and parent institution are informed of those observations, and a response describing the corrective actions to be taken is required (see 21 CFR 56.120[a]). If it is determined that the IRB or the institution has failed to take adequate steps to correct the noncompliance, and the FDA Commissioner determines that this noncompliance may justify the disqualification of the IRB or of the parent institution, “the Commissioner will institute proceedings in accordance with the requirements for a regulatory hearing set forth in part 16” (21 CFR 56.121). Of course, the regulatory scheme explicitly provides for court review of final administrative actions taken by the Commissioner (see 21 CFR 10.45[a]).

It is therefore clear that the procedures created by these regulations of IRBs, which include the possibilities of an adversarial regulatory hearing before the FDA (see 27 CFR 156.121[a]) and subsequent judicial review (see 21 CFR 10.45), qualify as a quasi-judicial process by an administrative agency, Stega v New York Downtown Hosp., 2017 NY Slip Op 00139, 1st Dept 1-10-17

 

DEFAMATION (PROCEEDINGS BEFORE THE FOOD AND DRUG ADMINISTRATION ARE QUASI-JUDICIAL IN NATURE, STATEMENTS PROTECTED BY ABSOLUTE PRIVILEGE)/PRIVILEGE (DEFAMATION, PROCEEDINGS BEFORE THE FOOD AND DRUG ADMINISTRATION ARE QUASI-JUDICIAL IN NATURE, STATEMENTS PROTECTED BY ABSOLUTE PRIVILEGE)/ABSOLUTE PRIVILEGE (DEFAMATION, QUASI-JUDICIAL PROCEEDINGS, PROCEEDINGS BEFORE THE FOOD AND DRUG ADMINISTRATION ARE QUASI-JUDICIAL IN NATURE, STATEMENTS PROTECTED BY ABSOLUTE PRIVILEGE)/QUASI-JUDICIAL PROCEEDINGS (DEFAMATION, FOOD AND DRUG ADMINISTRATION, PROCEEDINGS BEFORE THE FOOD AND DRUG ADMINISTRATION ARE QUASI-JUDICIAL IN NATURE, STATEMENTS PROTECTED BY ABSOLUTE PRIVILEGE)

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