http://exhibits.library.stonybrook.edu/mfp/files/original/b4194801a04085e11450a0fcdbebf572.pdf 43bc9503d2261970439acb750cceef51 PDF Text Text February 12, 1986 Robert Millman, M.D. Department of Psychiatry New York Hospital Medical Center 525 East 68 Street New York City 10021 Dear Bob, I am writing with regard to the story, "Psychiatrists Challenge FDA" which appeared this month in Psychiatric Times. If the story represents your views, then I support the questions which you raise with the FDA. Our interest is not with regard to the bioequivalence of generics for thioridazine, but a similar question regarding diazepam. Last year, my former co-worker Turan Itil assessed the CNS patterns of and some generic formulations of diazepam, finding differences in quantitative EEG measures. I was asked by physicians at Hoffmann-La Roche to review his data. I was impressed that his findings were probably real. They require replication, of course. When the petition was made to the FDA for an elaboration of the regulations, to include the requirement that similar studies be done for generics to demonstrate CNS bioequivalence, the FDA answers given were, as you noted, vague and indefinite; the petition was denied; and manufacturers of generic formulations of diazepam were licensed to market their products. Valium Since Itil's methods are very advanced, we have decided to tool up to replicate his studies. Our interest is not in the legal issues or in the methodology, but in applying his methods to other problems. Nevertheless, I am upset that the FDA gave so little credence to these data. I recently published a summary of my EEG experiences with different formulations of psychoactive compounds (Integrative Psychiatry 2(Supplement): 125-195, 1985). In it I note some clinical experiences, similar to those reported by others, which could have resulted from variations in dosage, perhaps occasioned by differences in formulations. I encourage your efforts in getting the FDA to provide meaningful guidelines and recording requirements for generic formulations of psychoactive substances. Let me know if I can be of any help. My regards. Sincerely yours, Max Fink, M.D. Professor of Psychiatry � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Correspondence Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Correspondence to: Millman, Robert B. Type The nature or genre of the resource Text Identifier An unambiguous reference to the resource within a given context mfp-05-00-030-8-246 Date A point or period of time associated with an event in the lifecycle of the resource 1986 Creator An entity primarily responsible for making the resource <a title="Fink, Max, 1923-" href="http://id.loc.gov/authorities/names/n79039548" target="_blank">Fink, Max, 1923-</a> Subject The topic of the resource Correspondence -- Correspondence Relation A related resource The Max Fink Collection Description An account of the resource Rights Information about rights held in and over the resource <a title="IN COPYRIGHT - EDUCATIONAL USE PERMITTED" href="http://rightsstatements.org/vocab/InC-EDU/1.0/" target="_blank">IN COPYRIGHT - EDUCATIONAL USE PERMITTED</a> Source A related resource from which the described resource is derived Special Collections and University Archives, University Libraries. Stony Brook University Libraries (State University of New York). Language A language of the resource en-US Format The file format, physical medium, or dimensions of the resource application/pdf Publisher An entity responsible for making the resource available Contributor An entity responsible for making contributions to the resource Correspondence