CNPR Compliance and Ethics 4 — Questions and Answers
Question 1: A company's compliance program is considered effective by the OIG (Office of Inspector General) when it includes which core element?
- A commitment to maximizing sales revenue above all other goals
- Written policies, procedures, and standards of conduct (Correct answer)
- Unlimited discretion for sales managers to approve physician gifts
- A policy allowing off-label promotion when data supports it
Correct answer: Written policies, procedures, and standards of conduct
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:
- Selecting only the most favorable clinical study data to present to physicians (Correct answer)
- Targeting only the highest-prescribing physicians in a territory
- Focusing sales calls on specialists rather than primary care physicians
- Choosing premium samples to distribute to preferred physicians
Correct answer: Selecting only the most favorable clinical study data to present to physicians
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:
- Mentions a competitor drug by name
- Makes implied claims not supported by substantial evidence (Correct answer)
- Uses patient testimonials without FDA approval
- Shows a physician actor rather than a real physician
Correct answer: Makes implied claims not supported by substantial evidence
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:
- Falsify their own records to match the manager's numbers and avoid conflict
- Confront the manager publicly at the next team meeting
- Report the misconduct through the company's compliance hotline or ethics officer (Correct answer)
- Wait to see if the manager self-corrects before taking any action
Correct answer: Report the misconduct through the company's compliance hotline or ethics officer
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?
- The physician is a recognized expert in the therapeutic area
- The consulting fee significantly exceeds fair market value for the services rendered (Correct answer)
- The company has a written contract with clearly defined deliverables
- The physician discloses the relationship on grant applications
Correct answer: The consulting fee significantly exceeds fair market value for the services rendered
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.
Question 6: What does the term 'formulary status' mean in the context of pharmaceutical sales compliance?
- The legal form that must be filed when a new drug is approved by the FDA
- Whether a drug is covered by a health plan's approved list of medications (Correct answer)
- The standard dosage form in which a drug is manufactured
- The official classification of a controlled substance by the DEA
Correct answer: Whether a drug is covered by a health plan's approved list of medications
Formulary status refers to whether a drug has been approved by a pharmacy benefit manager or insurance plan for coverage, affecting access and cost to patients.
Question 7: A pharmaceutical representative who engages in 'off-label detailing' — promoting unapproved uses to physicians — risks which consequence for their company?
- Only a minor fine under PhRMA guidelines
- Corporate exclusion from federal healthcare programs and potential False Claims Act liability (Correct answer)
- A temporary suspension of the drug's FDA approval
- Mandatory retraining of all sales staff with no financial penalty
Correct answer: Corporate exclusion from federal healthcare programs and potential False Claims Act liability
Off-label promotion can result in corporate exclusion from Medicare/Medicaid and massive False Claims Act settlements, as demonstrated by multiple billion-dollar enforcement actions.
CNPR Compliance and Ethics 4
A company's compliance program is considered effective by the OIG (Office of Inspector General) when it includes which core element?