Union Corner: Ethics & Integrity

NOTE: This article was precipitated when two CDER medical reviewers, Drs. Leo Lutwak and Robert Misbin, became subjects of an FDA (Office of) Internal Affairs investigation in connection with Rezulin, a drug withdrawn in March 00 from the U.S. market in part because of its hepatotoxicity. The Office of Internal Affairs has responsibility for investigating CRIMINAL activity on the part of FDA employees. A series of investigative (background) reports on Rezulin is on The Times’ Web site: http://www.latimes.com/rezulin.

See also, LA Times wins 2001 Pulitzer Prize for Expose of FDA. NTEU's efforts to aid and protect reviewers recognized.

1. All FDA employees, including supervisors and managers, are bound by the Code of Ethics for Government Service which imposes an obligation to “put loyalty to the highest moral principles and to country above loyalty to persons, party, or government department,” to “uphold the Constitution, laws, and legal regulations of the United States, and of all governments therein and never be a party to their evasion,” and to “expose corruption wherever discovered....” 175 72 Stat B12, 1958; 21 CFR 19.6; NTEU-FDA Contract, Article 5, Section 14. Breaches of this NTEU-FDA Contract provision by supervisors and managers may be remedied as a Grievance pursuant to the NTEU-FDA Contract, Article 45.

2. Bargaining unit employees have a right to express and to abide by their professional opinion and not to be penalized for exercising their right to their honest opinions. NTEU-FDA Contract, Article 5, Section 20. See also “NTEU-FDA Contract, part II (Contract Preview)”, Chapter Guides section, Chapter 282 web site: www.nteu282.org, and 21 CFR 10.70 and 10.75. Breaches of this NTEU-FDA Contract provision by supervisors and managers may be remedied as a Grievance pursuant to the NTEU-FDA Contract, Article 45.

3. All FDA employees are bound by law and the NTEU-FDA Contract to Merit System Principles, which includes protection “against reprisals for the lawful disclosure of information which the employees reasonably believe evidences a violation of any law, rule, or regulation, or mismanagement, a gross waste of funds, and abuse of authority, or a substantial and specific danger to public health and safety.” 5 USC 2301; NTEU-FDA Contract, Article 5, Attachment 5-1. Breaches of this NTEU-FDA Contract provision by supervisors and managers may be remedied pursuant to the Grievance Procedure set out in the NTEU-FDA Contract, Article 45.

4. FDA supervisors and managers are bound by law and the NTEU-FDA Contract not to commit prohibited personnel practices including taking or failing to take a “personnel action with respect to any employee or applicant for employment as reprisal for...a disclosure of information by an employee or applicant which the employee or applicant reasonably believes evidences a violation of any law, rule, or regulation, or mismanagement, a gross waste of funds, and abuse of authority, or a substantial and specific danger to public health and safety...if such disclosure is not specifically prohibited by law....” 5 USC 2302; NTEU-FDA Contract, Article 5, Attachment 5-1. Breaches of this NTEU-FDA Contract provision by supervisors and managers may be remedied pursuant to the Grievance Procedure set out in the NTEU-FDA Contract, Article 45.

   A public interest organization, Health Research Group (HRG), has asked HHS to be sure that FDA follows the above laws and regulations. See HRG 22 Mar 00 letter at http://www.citizen.org/hrg/PUBLICATIONS/1516.htm. Heath Research Group is a non-profit, consumer research and advocacy organization, founded by Ralph Nader and Dr. Sidney Wolfe in 1971. Relentlessly over the past three decades it has fought for citizen and consumer justice and for government and corporate accountability. In the area of medicines it seeks to ensure that the consumer gets what he or she pays for - a safe and effective drug.

   Health Research Group in concert with all branches of the federal government has always understood that the sure foundation of FDA decisions is the integrity of its employees. FDA employees can only do their best work in a free and open professional environment (Points 2, and 4 above) guided by only the loftiest of ideals (Points 1, and 3 above). Such a work environment is totally in accord with NTEU’s mission “to ensure that every federal employee is treated with dignity and respect.” In order to make these ideals a reality in an imperfect world, Chapter 282 is committed to offering every member of the bargaining unit the rights and safeguards outlined in Points 5 and 6 below.

5. Bargaining unit employees subjected to an investigatory interview have a right to a union representative. See 5 USC 7114; NTEU-FDA Contract, Article 5, Section 2 and 3. See also “Right to a Union Representative,” Chapter Guides section, Chapter 282 web site: www.nteu282.org. Breaches of this NTEU-FDA Contract provision by supervisors, managers and other agency representatives may be remedied pursuant to the Grievance Procedure set out in the NTEU-FDA Contract, Article 45.

6. Pursuant to the NTEU-FDA Contract, Article 45, Section 2, a bargaining unit employee can grieve “the effect or interpretation, or a claim of breach, of the Agreement...or any claimed violation, misinterpretation, or misapplication of any law, rule, or regulation affecting the conditions of employment.” Grievances related to continuing violations may be brought at any time. Discrete grievances must be submitted in writing to the FDA HR representative within twenty (20) calendar days after the matter, issue or incident out of which the grievance arose.

Contact a chapter steward, if you need assistance.