CERTIFICATION: GOVERNMENT
EXCLUSIONS AND DEBARMENT
(EXCLUSIONS FROM FEDERAL HEALTH CARE PROGRAMS ANDGOVERNMENT PROCUREMENT AND NON-PROCUREMENT PROGRAMS,FDA DEBARMENT)
Background
A.Exclusion from Federal Health Care Programs
Under the Social Security Act, the Office of Inspector General for the United States Department of Health and Human Services (“OIG”) can “exclude” individuals or entities from federally-funded health care programs.
Exclusions can occur for a variety of reasons including criminal conviction of an individual or entity of certain crimes. Examples include crimes regarding: (1) Medicare or Medicaid fraud; (2) the delivery of an item or service for which a federal health care program pays that the program should not pay for; (3) patient abuse or neglect; (4) theft or financial misconduct; or (5) unlawful manufacture, distribution, prescription or dispensing of controlled substances.
In addition, OIG may exclude an individual or entity for non-criminal activity. For example, OIG may exclude individuals for: (1) the suspension, revocation, or surrender of a license to provide health care for reasons bearing on professional competence, professional performance, or financial integrity; provision of unnecessary or substandard services; (2) submission of false or fraudulent claims to a Federal health care program; (3) engaging in unlawful kickback arrangements; (4) defaulting on health education loan or scholarship obligations; or (5) controlling a sanctioned entity as an owner, officer, or managing employee.
Note, the examples above are just examples and there are other bases upon which OIG may exclude an individual or entity.
B.GSA Debarment - Exclusion from Federal Government Procurement and Nonprocurement Programs
The General Services Administration (GSA) maintains databases of individuals or entities that have been excluded from participation in Federal programs such as those under the Federal Acquisition Regulation (FAR). A person who is debarred or suspended is excluded from federal financial and non-financial assistance and benefits under federal programs and activities. Debarment or suspension of a participant in a program by one agency has a government-wide, reciprocal effect.
C.FDA Debarment
The United States Food and Drug Administration (“FDA”) places a debarment on persons or companies that engage in criminal conduct in violation of the United States Food Drug and Cosmetics Act. Typically sanctions originate due to felonies that include such offenses as submitting false data to the Federal Food and Drug Administration, lying to FDA investigators, paying for or accepting bribes and selling prescription drug samples. Part of the FDA’s authority for debarment comes from what is known as the Generic Drug Enforcement Act of 1992, often called the “debarment act” as it authorizes or requires debarment for people (or companies) convicted of certain crimes.
Under the provisions of the Debarment Act, pharmaceutical companies are required to take steps to ensure that their employees and contract laborers have not been involved in activities that would call into question the validity of data submitted to the FDA. Such data includes any information regarding the development or approval of any drug product, production, quality assurance, or quality control of any drug product, distribution and sale of such product or the research and development of any drug product.
***
As a pharmaceutical manufacturer that participates in the Federal health care programs and in keeping with our company value of high ethical standards and corporate responsibility, we are requesting that you sign the attached Certification. The Certification will be kept on file and applies to all United States and Puerto Rico based employees and contractors. In the event that after you provide this Certification your circumstances change such that the Certification is no longer accurate, you are required to immediately notify the NA Compliance Department via phone at 1-800-648-1297 or via email at . As part of the annual recertification of the Code of Ethics and US Supplement you are required to review the original debarment certification and, if applicable, document any changes.
CERTIFICATION RE GOVERNMENT EXCLUSIONS AND DEBARMENT
Please respond to the following questions to the best of your knowledge and provide further explanation as necessary to clarify your answers. If you require additional space, please attach additional pages to this form as needed.
FEDERAL HEALTH CARE PROGRAM EXCLUSION AND GSA DEBARMENT
1.I am currently excluded, debarred, suspended, or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or nonprocurement programs.
__ YES___ NO
If Yes, please provide explanation:
2.I have been convicted of a criminal offense that could be the basis for exclusion from a Federal health care program but have not yet been excluded, debarred, suspended, or otherwise declared ineligible to participate in the Federal health care programs or in Federal procurement or nonprocurement programs.
__ YES___ NO
If Yes, please provide explanation:
FDA DEBARMENT
1.I certify that I have never materially participated in any illegal act relating to the development and approval of drug products, including, but not limited to, submitting false data to governmental authorities and falsifying records that are maintained by pharmaceutical and consumer health companies. (If you are unable to make such certification, please explain and attach pages if needed.)
2. I certify that I have not been subject to an arrest that is currently pending which has not been followed by a termination of a criminal action in my favor for any of the following offenses: (1) any criminal offense relating to the development and approval of drug products, (2) bribery, (3) payment of illegal gratuities, (4) fraud, (5) perjury, (6) false statements, (7) racketeering, (8) blackmail, (9) extortion, (10) falsification or destruction of records, (11) interference or obstruction of an investigation into, or prosecution of, any criminal offense, (12) any conspiracy to commit or aiding or abetting the aforementioned crimes. (If you are unable to make such certification, please explain and attach pages if needed.)
3. I certify that I have not been convicted within the past five years of any of the following criminal offenses: (1) any criminal offense relating to the development and approval of a drug product, (2) bribery, (3) payment of illegal gratuities, (4) fraud, (5) perjury, (6) false statements, (7) racketeering, (8) blackmail, (9) extortion, (10) falsification or destruction of records, (11) interference or obstruction of an investigation into, or prosecution of, any criminal offense, (12) or any conspiracy to commit or aiding or abetting the aforementioned crimes. (If you are unable to make such certification, please explain and attach pages if needed.)
4. I certify that I am not debarred by the United States Secretary of Health and Human Services or his/her delegees pursuant to the Generic Drug Enforcement Act of 1992. (If you are unable to make such certification, please explain and attach pages if needed.)
5. I certify that I have never worked as an employee, contract labor or a consultant for a corporation, partnership, association, or individual that has been debarred by the United States Secretary of Health and Human Services or his/her delegee pursuant to the Generic Drug Enforcement Act of 1992. (If you are unable to make such certification, please explain and attach pages if needed.)
6. I certify that I have never been convicted of a criminal offense relating to the sale of drug samples. (If you are unable to make such certification, please explain and attach pages if needed.)
7. I recognize that these certifications are ongoing during my employment/engagement and I agree to immediately advise my supervisor and the NA Compliance Department if circumstances change such that (1) I can no longer make the above certifications or (2) the explanations provided above are no longer complete and accurate.
Name: ______Signature: ______
Dept.: ______Date: ______
Sanofi US ● 55 Corporate Drive ● PO Box 5925 ● Bridgewater, NJ 08807-5925
Telephone (908) 981-5000 ●