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EPITOPE RECEIVES FDA LETTER REGARDING PREMATURE RELEASE OF DOCUMENTS

EPITOPE RECEIVES FDA LETTER REGARDING PREMATURE RELEASE OF DOCUMENTS
 BEAVERTON, Ore., June 24 /PRNewswire/ -- Epitope Inc. (AMEX: EPT) today received a letter from the U.S. Food and Drug Administration (FDA) expressing the agency's regret that the "premature" release of an internal document had caused confusion about the status of Epitope's pending premarket approval (PMA) application covering OraSure(R), the company's oral specimen collection device for AIDS testing, Epitope said. The document, an Establishment Inspection Report (EIR), was the subject of widespread speculation. This speculation appears to have prompted several securities lawsuits recently filed against the company.
 The FDA letter stated, "We regret that the release of the EIR, which occurred prior to its evaluation by officials of the Center for Biologics Evaluation and Research, may have caused confusion among persons outside of the agency about the status of your product application. To prevent such occurrences in the future, the agency is taking steps to ensure that all personnel responding to Freedom of Information Act requests understand that an EIR should not be released under these circumstances.
 "The agency appreciates Epitope's responsiveness to the questions raised during the review of your PMA and in the course of the inspections, and we look forward to continued cooperation as the review process proceeds through the normal course," the FDA letter concluded.
 Commenting on the letter, Adolph J. Ferro, president and chief executive officer, said, "We believe that the observations contained in the EIR have been interpreted not only out of context but also without benefit of knowledge of the filing made by Epitope in response to FDA concerns. As the FDA has indicated, the specifics of the comments in an EIR are ordinarily not released until the application process is concluded. However, given reports of widespread distribution of the EIR, we are providing a more complete description of the status of our filing."
 Epitope Inc. is an Oregon corporation utilizing biotechnology to develop diagnostic tests for AIDS and other indications, therapeutic antimicrobial drugs and, through its agricultural unit, Agritope Inc., superior new plant varieties.
 Text of FDA letter follows:
 Department of Health & Human Services
 Office of the Commissioner
 5600 Fishers Lane
 Room 14-105, HF-7
 301-443-1306
 June 23, 1992
 Adolph J. Ferro, Ph.D.
 President
 Epitope, Inc.
 8505 SW Creekside Place
 Beaverton, OR 97005
 Dear Dr. Ferro:
 This responds to your telephone inquiries to FDA officials, and to the letter to Mr. Mark Elengold, dated June 16, 1992, sent on your behalf by Edward L. Korwek, Esq., concerning the release of records relating to Epitope's pending Pre-Market Application for approval of Orasure HIV-1 Oral Specimen Collection device. Specifically, you asked whether the agency released an Establishment Inspection Report (EIR) of inspections of your firm conducted on November 18-21, 1991, December 20, 1991, and April 30, 1992.
 I have consulted with numerous agency officials and employees at FDA headquarters and district offices about this matter and can confirm that the agency disclosed this EIR in response to a request made under the Freedom of Information Act. We have concluded that the release of the EIR was premature in light of the fact that the final review and classification had not yet been completed. Although the disclosure of such records is within the discretion of the Commissioner, it is FDA's policy to deny requests for release of an EIR until the agency review is completed and the matter is closed. Requests for the release of such reports can be denied in accordance with the Freedom of Information Act, 5 U.S.C. S 552, and FDA's public information regulations, 21 C.F.R. SS 20.1 et seq., because an EIR, as stated in the preamble to FDA's regulations, is "both an intra-agency memorandum and part of an investigatory file..." 39 Fed. Reg. 44622 (Dec. 24, 1974). The EIR is "not a simple list of factual observations." Id. Instead, the EIR "contains personal conclusions and recommendations for consideration only within the Food and Drug Administration." Id. While review of inspection results is pending, the EIR is not disclosed to anyone outside the agency. See 39 Fed. Reg. 44622; 21 C.F.R. SS 20.62, 20.64.
 In contrast, FDA 483 forms are routinely released, since that form is provided to the firm, and contains the factual observations of the investigators. 21 C.F.R. S 20.101. This distinction also is discussed in the preamble to the public information regulations. See 39 Fed. Reg. 44622.
 We regret that the release of the EIR, which occurred prior to its evaluation by officials of the Center for Biologics Evaluation and Research, may have caused confusion among persons outside of the agency about the status of your product application. To prevent such occurrences in the future, the agency is taking steps to ensure that all personnel responding to Freedom of Information Act requests understand that an EIR should not be released under these circumstances.
 The agency appreciates Epitope's responsiveness to the questions raised during the review of your PMA and in the course of the inspections, and we look forward to continued cooperation as the review process proceeds through the normal course.
 Sincerely yours,
 /s/
 Amanda B. Pedersen
 Chief Mediator and Ombudsman
 cc: Edward L. Korwek, Esq.
 EPITOPE STATEMENT REGARDING STATUS OF PENDING ORASURE(R)
 PREMARKET APPROVAL APPLICATION
 In May 1991, the company filed the OraSure Premarket Approval Application (PMA) with the Food and Drug Administration (FDA). In November 1991, the FDA issued a letter with respect to its review of the PMA. In November and December 1991 FDA staff also visited Epitope to inspect documents supporting the PMA and to discuss proposed revisions to the PMA. On April 30, 1992, the FDA issued an inspectional form (Form 483) to the company summarizing observations of FDA staff arising from the visits to the company in November and December 1991. The Form 483 was a brief three-page listing of observations made by the staff during the visits, all of which had been previously discussed with the company and which had been addressed either by discussion and agreement with FDA staff or in an amendment to the PMA filed in mid-April 1992. In June 1992, the FDA released the Form 483 pursuant to a Freedom of Information Act request, together with a 21-page Establishment Inspection Report (EIR), a document which according to the FDA "...contains personal conclusions and recommendations for consideration only within the Food and Drug Administration." The company had not seen the EIR before its release to the public.
 The company's original PMA filing summarized the results of clinical trials and supplemental studies designed to demonstrate the safety and efficacy of the OraSure oral specimen device for an intended use with an HIV-1 screening test, called an enzyme linked immunoassay or "ELISA," and a Western blot confirmatory test. Among the issues covered by the filing was a change of HIV confirmatory test interpretive criteria as compared to the criteria currently in use for blood samples. Following discussions with FDA staff the company agreed to limit its initial amendment qualifying the OraSure device for use with the ELISA screening test and to apply for approval of the confirmatory use in a subsequent amendment. The company has now made a modification to its confirmatory test which is intended to optimize its use with an oral sample and is not expected to require a change in interpretive criteria. The company expects to file a confirmatory test amendment in the near future, after additional clinical trials, if necessary, have been completed.
 For the initial OraSure PMA filing, the company assembled data from five clinical trial sites and reviewed it for accuracy. In certain cases, an in-house review committee made changes to Western blot results where the company felt the original interpretation was in error. This process was described in the company's original PMA filing.
 After the initial PMA filing, the FDA visited the company and each clinical site and performed a thorough review. In reviewing clinical site documents and comparing them to the company's data compilations, FDA staff found clerical errors and inadvertent duplication of patient data which were subsequently corrected; the effect of the corrections on study results was inconsequential. With respect to Western blot interpretive changes made by the company, FDA staff recommended, and the company agreed, to a review of the company's interpretations by independent experts. It is important to understand that in a minority of cases involving either blood or oral samples, experts may disagree on interpretation of Western blot results. In the review of the clinically relevant category identified by the FDA, the independent reviewers agreed with 85 percent of the interpretative changes made by the company.
 The staff requested expansion of clinical trials to more thoroughly demonstrate the effectiveness of the device with respect to testing low-risk populations and sample collection by non-medical personnel. Due to mechanical improvements which the company has made to production models of the device, the staff also requested additional studies to demonstrate that results obtained with the current device configuration are concordant with results obtained with the configuration used in the clinical trials. Additionally, the company agreed to expand its stability studies to demonstrate reproducibility of test results despite storage of samples under a range of temperatures which correspond to clinical trial conditions or conditions anticipated in commercial use of the product. In each case, the company incorporated the requested work into the PMA amendment.
 -0- 6/24/92
 /CONTACT: Mary Hagen of Epitope, 503-641-6115; or Shari Annes of Annes Associates, 415-726-5400, for Epitope/
 (EPT) CO: Epitope Inc.; U.S. Food and Drug Administration ST: Oregon IN: MTC SU:


SC-LM -- SE010 -- 3539 06/24/92 21:08 EDT
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