CNPR Compliance and Ethics 4

Question 1

A company's compliance program is considered effective by the OIG (Office of Inspector General) when it includes which core element?

Accepted Answer

Written policies, procedures, and standards of conduct

Answer

OIG's model compliance program guidance identifies written policies, procedures, and standards of conduct as a foundational element of an effective compliance program.

Question 2

In pharmaceutical sales, 'cherry-picking' refers to the unethical practice of:

Accepted Answer

Selecting only the most favorable clinical study data to present to physicians

Answer

Cherry-picking involves selectively presenting only favorable clinical data while omitting negative or contradictory studies, which is misleading and violates FDA regulations.

Question 3

Under FDA regulations, a pharmaceutical advertisement is considered 'false or misleading' if it:

Accepted Answer

Makes implied claims not supported by substantial evidence

Answer

Advertising is false or misleading if it makes claims, including implied ones, that are not supported by substantial evidence or substantial clinical experience.

Question 4

A pharmaceutical representative discovers their manager has been falsifying call records. The representative's ethical obligation is to:

Accepted Answer

Report the misconduct through the company's compliance hotline or ethics officer

Answer

Employees have an ethical and often contractual obligation to report misconduct through appropriate channels such as a compliance hotline or ethics officer.

Question 5

Which of the following is a red flag that a physician's consulting arrangement with a pharmaceutical company may violate the Anti-Kickback Statute?

Accepted Answer

The consulting fee significantly exceeds fair market value for the services rendered

Answer

Consulting fees that exceed fair market value for genuine services may indicate that the excess payment is actually an inducement to prescribe, violating the Anti-Kickback Statute.

(CNPR) Certified National Pharmaceutical Representative Practice Test

(CNPR) Certified National Pharmaceutical Representative Practice Test

CNPR Compliance and Ethics 4