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• W62019488 abstract "DESPITE vigorous defense counsel protests, courts have compelled drug and device manufacturers to produce drug reaction or product experience reports, which are to collectively as adverse reports. Yet, those anecdotal, unexplained, unverified hearsay, reports, or summarizations of them, contain confidential and private information. They also have absolutely no bearing on causation in either the case in which a plaintiff seeks to compel their production or in the reported events themselves. Pursuant to the Food and Drug Administration's final rule, Protecting the Identities of Reporters of Adverse Events and Patients; Preemption of Disclosure Rules, manufacturer-compelled production of an unedited, voluntarily submitted report will be disallowed. Indeed, the final rule, which became effective on July 3, 1995, also will protect the identities of the reporters of, patients experiencing, and others involved with events that are the subject of voluntarily submitted reports concerning human drugs, biologics and medical devices. What is the background of the rule and what will be its impact on product liability litigation? SETTING THE STAGE Drug manufacturers, patients and health professionals send post-marketing reports directly to the FDA. Patients and health professionals also send or report events directly to manufacturers, who in turn complete reports and forward them to the FDA. The FDA also relays reports to manufacturers. Adverse reports possessed by the FDA are governed by federal regulations protecting the confidentiality of voluntary reporters of, patients experiencing, and third parties involved with events. Generally speaking, the regulations, Section 20.111(c) of the Code of Federal Regulations does not allow manufacturers, absent a court order, to withhold reports or the identities of voluntary reporters of, persons experiencing, or others involved with events. Similarly, Section 519(b)(3) of the Safe Medical Device Act of 1990, 21 U.S.C. [sections] 360i(e), also is deficient in protecting the disclosure of confidential data and information possessed by manufacturers. As the FDA has recognized, Section 360i(e) is really not sufficient to prevent manufacturers from being compelled to release the reporters' or patients' identities pursuant to a discovery order.(1) Since neither Section 20.111(c), Section 360i(e) nor other federal regulations allows manufacturers to withhold reports or the confidential, information contained in them, courts have compelled manufacturer disclosure of mandatory and voluntarily submitted reports and information. Compelled disclosure, however, has a chilling effect on the voluntary reporting process because reporters, especially physicians, fear that submitting reports increases their potential for being involved in litigation. Physicians also fear that patient identity would be disclosed, breaching the physician-patient privilege.(2) In light of that chilling effect, the FDA filed position papers with courts and argued that compelled disclosure would impede its postmarket surveillance efforts. Subsequently, it issued a proposed rule amending its public information regulations.(3) PROPOSED AND FINAL RULES To enhance the protection of the identities of voluntary reporters, patients experiencing and others involved with events, the FDA in January 1994 proposed an amendment to its regulations. After a period of comment, the final rule was published in the April 3, 1995, issue of the Federal Register and now is codified as Section 20.63(f) of the Code of Federal Regulations. It states: [sections] 20.63 Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy. (f) The names and any information that would identify the voluntary reporter or any other person associated with an event involving a human drug, biologic, or medical device shall not be disclosed by the Food and Drug Administration or by a manufacturer in possession of such reports in response to a request, demand, or order. …" @default.
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• W62019488 date "1996-01-01" @default.
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• W62019488 title "Preventing Compelled Disclosure of Adverse Event Reports" @default.
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