COVER MEMORANDUM - SAMPLE
TO: Linda Ann Sherman, MD, Advisory Committee Oversight, OSAC
THROUGH: Jenny S. Slaughter, Team Leader, Ethics Staff Ethics Staff, Division of Management Programs
FROM: Contact CenterSUBJECT:
Purpose of the Meeting or Homework:
Disclosures not requiring further action (describe the interest in enough detail for the reviewing officials to understand the basis for the action):
Waivers (see attached checklists and waivers for details):
502 Determinations are forwarded to the Senior Associate Commissioner (see attached checklists and 502 documents for details):
Notes from Ethics Staff:
Actions in which we do not concur:
Special Concerns or Considerations:
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CDER Advisory Committee: Antiviral Drugs Advisory Committee
Meeting Date: November 29, 1999
New Drug Application (NDA) 20-123, Varid (movirapine), sponsored by ABC Laboratories, a subsidiary of Boehringer Ingelheim Pharmaceuticals, for use in the treatment of Human Immunodeficiency Virus (HIV) infection.
The competing products to Varid are:
Epivir (3TC, lamivudine), Glaxo Wellcome
Videx (didanosine, ddI), Bristol Myers Squibb
Hivid (zalcitabine, ddC), Hoffmann LaRoche, including Roche Holding Ltd.
Dr. Michael Smith's wife owns 100 shares of stock in Glaxo Wellcome, worth approximately $5,300. The stock represents less than 5% of their net worth.
Section 208(b)(3) Waiver - Circumstances favoring use:
___________________________________ Prepared by Date ___________________________________ Ethics Reviewer Date
MEMORANDUM - SAMPLE
DATE: TO: Linda A. Suydam, D.P.A. Senior Associate Commissioner Food and Drug Administration THROUGH: Jenny Slaughter Team Leader, Ethics Staff Division of Management Programs, OHRMS FROM: John Treacy Director, Advisors and Consultants Staff Center for Drug Evaluation and Research SUBJECT: Conflict of Interest Waiver for Michael Smith, M.D.
I am writing to request a waiver for Michael Smith, M.D., a member of the Antiviral Drugs Advisory Committee, from the conflict of interest prohibitions of 18 U.S.C. section 208(a). Waivers under section 208(b)(3) may be granted by the appointing official where "the need for the individual's services outweighs the potential for a conflict of interest created by the financial interest involved" and where the individual has made a disclosure of the financial interests at issue. We have determined that you are the appointing official for purposes of section 208. Therefore, you have the authority to grant Dr. Smith a waiver under section 208(b)(3).
Section 208(a) prohibits Federal executive branch employees, including special Government employees, from participating personally and substantially in matters in which the employee or his employer has a financial interest. Since Dr. Smith is a special Government employee, he is under a statutory obligation to refrain from participating in any deliberations that involve a particular matter having a direct and predictable effect on a financial interest attributable to him or his employer.
The function of the Antiviral Drugs Advisory Committee is to review and evaluate available data concerning the safety and efficacy of marketed and investigational human drug products for use in the treatment of acquired immune deficiency syndrome (AIDS), AIDS-related complex (ARC) and other viral, fungal and mycobacterial infections, and to make appropriate recommendations to the Commissioner of Food and Drugs.
Dr. Smith has been asked to participate in New Drug Application (NDA) 20-123, Varid (movirapine), sponsored by ABC Laboratories, a subsidiary of Boehringer Ingelheim Pharmaceuticals, for use in the treatment of Human Immunodeficiency Virus (HIV) infection.
Dr. Smith has advised the Food and Drug Administration (FDA) that he has a financial interest which could potentially be affected by his participation in the matter described above. Dr. Smith's spouse owns stock in Glaxo Wellcome, the manufacturer of a competing product to Varid.
As a member of the Antiviral Drugs Advisory Committee, Dr. Smith potentially could become involved in matters that could affect his or his spouse's financial interests. Under section 208, he is prohibited from participating in such matters. However, as noted above, you have the authority under 18 U.S.C. section 208(b)(3) to grant a waiver permitting Dr. Michael Smith to participate in such matters as you deem appropriate.
For the following reasons, I believe that it would be appropriate for you to grant a waiver to Dr. Smith that would allow him to participate fully in the matter described below because the need for his services greatly outweighs the conflict of interest created by this financial interest.
First, Dr. Smith's imputed financial interest in Glaxo Wellcome is not so substantial as to preclude his participation in this matter. The stock represents a nominal financial interest.
Moreover, the Federal Advisory Committee Act requires that committee memberships be fairly balanced in terms of the points of view represented and the functions to be performed by the advisory committee. Also, the committee's intended purpose would be significantly impaired if the agency could not call upon experts who have become eminent in their fields, notwithstanding the financial interests and affiliations they may have acquired as a result of their demonstrated abilities. Dr. Smith specializes in internal medicine and infectious diseases. He has broad professional experience relating to the conduct of clinical trials relevant to HIV/AIDS, viral hepatitis, and cytomegalovirus and immunity. Dr. Smith's national stature is demonstrated by his participation in several national professional societies, such as the American Society for Microbiology, the Infectious Disease Society of America, the American College of Physicians, and the American Federation for Clinical Research. I believe that Dr. Smith's participation in the committee's deliberations will contribute to the diversity of opinions and expertise represented on the committee.
Accordingly, I recommend that you grant Dr. Michael Smith a waiver that would allow him to participate in all official matters concerning New Drug Application (NDA) 20-123, Varid (movirapine), sponsored by ABC Laboratories, a subsidiary of Boehringer Ingelheim Pharmaceuticals, for use in the treatment of Human Immunodeficiency Virus (HIV) infection. I believe that such a waiver is appropriate because in this case, the need for the services of Dr. Smith outweighs the potential for a conflict of interest created by the financial interest attributed to him.
CONCURRENCE: _____________________________________ Jenny Slaughter Date Team Leader, Ethics Staff Division of Management Programs, OHRMS DECISION: ____ Waiver granted based on my determination, made in accordance with section 208(b)(3), that the need for the individual's services outweighs the potential for a conflict of interest created by the financial interest attributable to the individual. ____ Waiver denied. ____________________________________ Linda A. Suydam, D.P.A. Date Senior Associate Commissioner Food and Drug Administration
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CDER Advisory Committee: Subcommittee of the Oncologic Drugs Advisory Committee - Quality of Life Subcommittee Meeting Date: Thursday, February 10, 2000
The Quality of Life Subcommittee will discuss issues related to the study of quality of life for patients enrolled in cancer trials. Specific potential areas for discussion include definition of patient-centered outcomes, clinical significance and interpretation of study results, and approaches to the statistical analysis of data.
The subcommittee's discussions are a particular matter of general applicability.
Lead Statistician, Cancer Center Statistics, Fitzgerald Clinic
Co-investigator, Phase II chemoprevention clinical trial for modulation of prostate intraepithelial neoplasia. National Cancer Institute, 9/96-9/01 ($1.85 million).
Co-investigator, A phase II clinical trial of antiestrogen and 5-alpha reductase inhibitors in patients with breast cancer. National Cancer Institute, 10/96-10/01 ($1.82 million).
Co-investigator, Dehydroepiandrosterone in monoclonal gammopathy of undetermined and borderline significance. National Cancer Institute. 1999-2000 ($1.85 million).
Co-investigator, Clinical studies of signal transduction inhibitors. National Cancer Institute Mentored Career Development Award 1997-2001 ($607,000).
Co-investigator, Eli Lilly Career Award in pre-menopausal women's health. 1998-2001 ($100,000).
Co-investigator, Cancer Chemoprevention: the role of infection and immunity.
National Cancer Institute. 1997-2000 ($3,611,786).
18 U.S.C. 208(b)(3) General Matters Waiver - Circumstances favoring waiver:
______________________________________ Prepared by Date ______________________________________ Ethics Reviewer Date
MEMORANDUM - SAMPLE DATE: TO: Linda A. Suydam, D.P.A. Senior Associate Commissioner Food and Drug Administration THROUGH: Jenny Slaughter Team Leader, Ethics Staff Division of Management Programs, OHRMS FROM: John Treacy Director, Advisors and Consultant Staff Center for Drug Evaluation and Research SUBJECT: General Matters Waiver Under 18 U.S.C. '208(b)(3) for John Jones, Ph.D.
John Jones, Ph.D., has been appointed as a special Government employee to the Center for Drug Evaluation and Research. This memorandum constitutes a determination, in accordance with 18 U.S.C. ß208(b)(3), that the need for the Dr. Jones' services, with respect to matters of general applicability, outweighs the potential for a conflict of interest created by any personal or imputed financial interest that he may have in matters of general applicability in which he is expected to participate.
Dr. Jones' participation in general applicability may affect certain financial interests of his or of persons and organizations with which he may have certain relationships.
This would include the following:
Under 18 U.S.C. section 208, Dr. Jones may not participate personally and substantially in a particular matter affecting these interests, unless he receives a waiver. Pursuant to my authority to grant waiver under 18 U.S.C. section 208(b)(3), I have determined that the need for Dr. Jones' services as a special Government employee, with respect to matters of general applicability, outweigh any concern that these types of interests might create the potential for a conflict of interest. Consequently, Dr. Jones may participate in matters of general applicability affecting any current and future financial interests of the types described above. This determination is based on the following considerations.
First and foremost, this waiver is justified, in part because of the general nature of the matters to be considered. It is well-recognized that general matters pose far less risk of a conflict of interest. Matters of general applicability include regulations, legislation, guidelines, points-to-consider, and polices governing classes of organizations, individuals, and products. General matters do not include particular matters involving specific parties, such as specific grants, contracts, recommendations regarding a specific product, or enforcement matters involving known parties. These matters will not have a unique and distinct impact on any of Dr. Jones' personal or imputed financial interests, but rather may affect classes of similarly situated products and manufacturers to the same extent.
This waiver is also justified because the Committee has a need for Dr. Jones' services, in light of his expertise in statistics. His participation will contribute to the diversity of views and expertise represented.
Further, the Committee Charter requires the appointment of individuals who are authorities knowledgeable in a variety of scientific and medical professions. Consequently, it is expected that persons qualified to serve on a Committee will have interests, financial and otherwise, related to the work of the Committee. This includes not only employment interests, but also investments and pension interests, as experience has demonstrated that persons employed in medical professions frequently acquire investments and pension interests in organizations related to their expertise. Financial interests simply are unavoidable in view of the work and membership requirements of advisory committees.
Moreover, the diversity of expertise required by the Charter ensures that no one participant is in a position to determine policy in favor of any one affected interest. Advisory committees are used to conduct public hearings on matters of importance that come before the Food and Drug Administration, to review the issues involved, and to provide advice and recommendations to the Commissioner. The Commissioner has sole discretion concerning action to be taken and policy to be expressed on any matter considered by an advisory committee. In addition, the Federal Advisory Committee Act requires fair balance and openness, which serve as important checks against real or apparent threats to the objectivity of Committee action.
Please note that this is a general matters waiver. It will not permit Dr. Jones to participate in any matters involving specific parties that may affect his financial interests, or any person or organization described above. When the work of the Committee moves from matters of general applicability to more specific matters (e.g., recommendations specific to an identified product), which could specifically affect Dr. Jones' personal and imputed financial interests, the Food and Drug Administration will examine Dr. Jones' interests in relation to the particular matter, and either obtain a specific waiver allowing him to participate, or exclude him from participating in the particular matter.
CONCURRENCE: _____________________________________________________ Jenny Slaughter, Team Leader, Ethics Staff Date Division of Management Programs, OHRMS DECISION: _______ General matters waiver granted based on my determination, made in accordance with section 208(b)(3), that the need for the individual's services outweighs the potential for a conflict of interest created by the financial interest attributable to the individual. _______ Waiver denied. _______________________________ Linda A. Suydam, D.P.A. Date Senior Associate Commissioner Food and Drug Administration
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COI CHECKLIST: CONFIDENTIAL - SAMPLE Appearance Determination
Committee: Biological Response Modifiers Advisory Committee Meeting Date: August 16, 1999 -- Conference Call Meeting Topics: To discuss a protocol for ABC product with doxorubicin, cyclophosphamide, and Paclitaxel with Tamoxifen and the same protocol without Tamoxifen for the treatment of node positive breast cancer.
Aurora (affected firm) - grants (2) - party matters - PI on unrelated research - 502 - medium involvement - one grant awarded from 1995-2000, other grant awarded from 1997-2001 to measure cardiac muscle injury using serum troponin T; and re-measure echocardiograms from many centers to study Zovac in children receiving adriamycin on the Pediatric Oncology Group and the Dana Farber Consortium clinical cancer trials. Total award is approximately $500,000 for the two grants.
Aurora (affected firm) - speaking engagement - medium involvement - 502 -- received $7,000 ($4,000 in travel expenses/$3,000 honorarium) on 9/10/98 for speaking on anthracycline cardiotoxicity issues.
Star Holdings, Ltd. (affected firm) - grant - party matters - low involvement - 502 - PI on an unrelated study - $30,000 - current - 1 year.
Section 2635.502 - Circumstances favoring use:
_______________________________ ________________ Prepared by Date ______________________________ _________________ Ethics Reviewer Date
DATE: August 13, 1999 FROM: William Freas, Ph.D. Chief, Scientific Advisors and Consultants Staff, CBER SUBJECT: Appearance Determination for John Doe, M.D. - SAMPLE TO: Linda A. Suydam, D.P.A. Senior Associate Commissioner Food and Drug Administration THROUGH: Linda Ann Sherman, M.D., M.P.A. Advisory Committee Oversight Staff, Director Office of the Senior Associate Commissioner
Under 5 C.F.R. section 2635.502 of the Standards of Ethical Conduct for Employees of the Executive Branch, where an employee (including special Government employees) knows that a particular matter involving specific parties is likely to have a direct and predictable effect on the financial interest of a member of his household, or knows that a person with whom he has a covered relationship is or represents a party to such matter, and where the employee determines that the circumstances would cause a reasonable person with knowledge of the relevant facts to question his impartiality in the matter, the employee should not participate in the matter unless he has informed the agency designee of the appearance problem and received authorization from the agency designee in accordance with paragraph (d) of section 2635.502.
This memorandum is to alert you to a situation involving Dr. John Doe, a consultant of the Biological Response Modifiers Advisory Committee of the Center for Biologics Evaluation and Research. Dr. Doe will be participating in a the August 16, 1999 meeting of the Biological Response Modifiers Advisory committee, which arguably could be considered a section 2535.502 situation. In this instance, we have determined that, as provided for in 5 C.F.R. section 2635.502, the interest of the Government in Dr. Doe's attendance and participation far outweighs the concern that a person may question the integrity of the Agency's programs and operations.
As is customary practice, an appropriate public disclosure of the situation will be made.
Dr. Doe has been asked to participate in official matters related to a discussion of a protocol for ABC product (manufactured by Geno, Inc., a subsidiary of Robot Holdings) with doxorubicin, cyclophosphamide, and Paclitaxel with Tamoxifen and the same protocol without Tamoxifen for the treatment of node positive breast cancer.
Dr. Doe reported that he has two current grants supported by Aurora, an affected firm. In addition, Dr. Doe has also reported an unrelated speaking engagement for Aurora. Aurora is one of the five firms that could be affected by the discussions. The fact that Dr. Doe has two grants supported by an affected firm could, however, be construed as an appearance problem under section 2635.502 of the Standards of Ethical Conduct. Fortunately, 5 C.F.R. section 2635.502 allows agencies to authorize such employees to participate in the matter, when it is determined that, in light of all relevant circumstances, the interest of the Government in the employee's participation outweighs the concern that the integrity of the Agency's programs may be questioned. Based on a number of factors, which may be taken into consideration, as specified in 5 C.F.R. section 2635.502(d), we have determined that it is in the best interest of the Government to allow Dr. Doe to participate in the discussions during the August 16, 1999 meeting.
Dr. Doe is a consultant to the Center for Biologics Evaluation Research and Review. He is employed by the University of Kentucky.
Dr. Doe has a current financial involvement with an affected firm. Dr. Doe is Principal Investigator of two grants on unrelated studies supported by Aurora. The amount awarded for both grants is approximately $500,000. In addition, on September 10, 1998, Dr. Doe spoke on an unrelated issue supported by Aurora. He received $7,000 ($3,000 honorarium/$4,000 travel expenses).
The resolution of this matter to affect the above disclosed financial interests of Dr. Doe's is considered remote.
Dr. Doe will be participating solely in an advisory capacity in which appropriate disclosure will be made of his involvement with Aurora. The Agency officials making the decisions are not bound by the decisions and recommendations of the members or any votes taken and may take into account Dr. Doe's involvement with Aurora. Dr. Doe has no discretion over the Food and Drug Administration or the matters under discussion. Therefore, the likelihood or appearance that Dr. Doe is subject to influence by Aurora is minimal.
The sensitivity of the discussion of the clinical trial protocol is considered low. This is not a product approval discussion.
Any appearance of partiality is greatly outweighed by FDA's particularly strong need for the services of Dr. Doe in this matter as discussed below.
Dr. Doe is Professor of Pediatrics at the University of Kentucky. He is board certified in pediatrics with specialties in pediatric cardiology and pediatric oncology. He has established himself as both a researcher and clinician in cardiology. Dr. Doe is Chairman of the Pediatric Oncology Group Cardiology Network and has served on numerous advisory committees and boards concerning cardiomyopathy research in therapeutic trials for hypertrophic cardiomyopathy.
Dr. Doe has extensive cardiotoxicity expertise. He is one of a few experts in the country with expertise in doxorubicin induced cardiomyopathy and the long term effects of cardiotoxic drugs. The patients in the study of issue (ABC product as adjuvant therapy) are younger patients with no current evidence of disease. Therefore, the long-term possible effects of ABC product induced cardiotoxicity are of importance. He participated as a consultant to the Oncology Drug Advisory Committee on September 2, 1998 for the discussions related to cardiac toxicity safety issues of ABC product.
Dr. Doe, therefore, is uniquely qualified to advise CBER on matters of cardiac toxicity related to adjuvant therapy with ABC product.
In light of the relevant circumstances, we believe that the interest of the Government in Dr. Doe's participation outweighs the concern that the integrity of the Agency's programs may be questioned, and that he should be permitted to participate in the discussions and deliberations concerning adjuvant therapy with ABC product.
CONCURRENCE ____________________________________________ Linda Ann Sherman, M.D., M.P.A. Date Advisory Committee Oversight Staff, Director Office of the Senior Associate Commissioner DECISION: Authorization granted based on my determination, made in light of all relevant circumstances, and in accordance with 5 C.F.R. section 2635.502, that the interest of the Government in the employee's participation outweighs the concern that the integrity of the Agency's programs may be questioned. _________ Authorization denied. ________________________________________ Linda A. Suydam, D.P.A. Date Senior Associate Commissioner Food and Drug Administration
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COI COVER PAGE FOR - SAMPLE
505(n)(4) Waiver for: Dr. Smith Date: 4/24/99
See attached financial information.
____________________ __________ Prepared by Date ____________________ __________ Ethics Reviewer Date
Section 120 of Food and Drug Administration Modernization Act of 1997
21 U.S.C. 355(n)(4)
Amendment of Section 505 of FD&C Act
This document is the 505(n)(4) waiver for:
Name: Dr. John Smith
Institution: University of California
Committee: Vaccines and Related Biological Products Advisory Committee
Meeting Date: May 26-27, 1999Topic: Malaria Vaccine (sponsor: Aurora, Inc.; affected firm: ABC Speedy
General Discussion on the Inclusion of a Boxed Warning on Package Inserts for Vaccines (sponsor of malaria vaccine is Aurora, Inc.; Competitor: ABC Speedy Corporation). The discussions will affect all manufacturers of vaccines. However, the discussions will specifically address the need for a boxed warning on a malaria vaccine manufactured by Aurora and ABC Speedy Corporation.
Summary of 505(n)(4) Requirements
The following applications of this Act for Dr. Smith are checked as follows.
X A. The Committee is a CBER Committee.
X B. The issue before the Committee is a particular matter: Malaria discussion and oral polio vaccine issue within the general discussions on labeling.
X C. The member or the member's immediate family has a financial interest in the product or competing product. The interest is as follows: Dr. Smith consulted with ABC Speedy Corporation and has attended speaking engagements sponsored by ABC Speedy Corporation. ABC Speedy Corporation is a competing firm for the Malaria vaccine discussion and is a competing firm with a licensed product for the oral polio labeling discussion.
X D. The individual's expertise has been considered and deemed essential by the Center (CBER or CDER), the Agency Ethics Staff and the Office of the Senior Associate Commissioner (Office of the Commissioner). See below or refer to 18 U.S.C. 208 waiver, if appropriate. See 208 waiver for matters of general applicability.
X E. The member's own scientific work is not under consideration by the Committee.
Accordingly, Section 505(n)(4) waiver
_________ is granted.
_________ is denied. _________________________________________ Linda A. Suydam, D.P.A. Date Senior Associate Commissioner Food and Drug Administration
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ADDENDUM TO WCD 2000
Confirmation of Discussion Points with Dr. Linda A. Suydam on 5/22/00
________________________________ _________________________________ Linda Ann Sherman, MD MPA Linda A. Suydam, DPA Director, Advisory Committee Senior Associate Commissioner Oversight Staff ________________________________ Jenny Slaughter Ethics Staff
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Office of the Commissioner
Food and Drug Administration
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