CNPR Compliance and Ethics 5 — Questions and Answers
Question 1: Which of the following correctly describes the difference between 'promotion' and 'education' in pharmaceutical industry standards?
- Promotion is FDA-regulated; education is completely unregulated
- Promotion is branded and intended to influence prescribing; education is independent, balanced, and not controlled by the company (Correct answer)
- Education must always be provided by company employees to ensure accuracy
- Promotion can only occur in person; education can occur in any format
Correct answer: Promotion is branded and intended to influence prescribing; education is independent, balanced, and not controlled by the company
Promotion is company-controlled messaging intended to drive prescribing, while independent medical education (CME) is not controlled by industry and must be unbiased.
Question 2: A representative is asked to submit expense reports that include meals coded under 'office supplies' to avoid scrutiny. This practice is:
- Acceptable if the meals were legitimate business expenses
- A violation of company policy and potentially constitutes fraud (Correct answer)
- Permissible as long as total spending stays within budget
- Only problematic if the amounts exceed $100 per meal
Correct answer: A violation of company policy and potentially constitutes fraud
Falsifying expense report categories constitutes expense fraud and violates company policy, ethical standards, and potentially federal law.
Question 3: Under the Prescription Drug Marketing Act (PDMA), pharmaceutical samples must be:
- Sold to physicians at a discount to encourage prescribing
- Distributed only to licensed practitioners and carefully documented (Correct answer)
- Given to any healthcare staff member who requests them
- Limited to new drugs approved within the past two years
Correct answer: Distributed only to licensed practitioners and carefully documented
PDMA requires that drug samples be given only to licensed practitioners and that companies maintain strict chain-of-custody records for all samples.
Question 4: What is the primary purpose of a 'Corrective Action Plan' (CAP) in pharmaceutical compliance?
- To punish employees who violate compliance policies
- To document a structured response to identified compliance deficiencies and prevent recurrence (Correct answer)
- To formally notify the FDA of a regulatory violation
- To justify terminating a non-compliant sales representative
Correct answer: To document a structured response to identified compliance deficiencies and prevent recurrence
A CAP is a proactive, documented plan that identifies the root cause of a compliance gap and outlines steps to correct and prevent recurrence.
Question 5: A physician who serves on an advisory board for a pharmaceutical company and also prescribes that company's drugs is at risk of a conflict of interest. The appropriate safeguard is:
- The physician should stop prescribing the company's drugs entirely
- Full disclosure of the financial relationship and independent prescribing decisions (Correct answer)
- The company should terminate the advisory relationship immediately
- No action is needed since advisory boards are exempt from the Sunshine Act
Correct answer: Full disclosure of the financial relationship and independent prescribing decisions
Disclosure of financial relationships and maintaining independent clinical judgment are the standard safeguards for physician-industry conflicts of interest.
Question 6: Which agency is primarily responsible for enforcing violations of the Anti-Kickback Statute in the pharmaceutical industry?
- The FDA's Office of Criminal Investigations
- The Department of Justice (DOJ) and Office of Inspector General (OIG) (Correct answer)
- The Federal Trade Commission (FTC)
- The Drug Enforcement Administration (DEA)
Correct answer: The Department of Justice (DOJ) and Office of Inspector General (OIG)
The DOJ and OIG have primary jurisdiction over Anti-Kickback Statute enforcement, often working with the FBI and state attorneys general.
Question 7: A sales representative who is aware of a serious adverse event involving their company's drug must report it to their company's pharmacovigilance department within what timeframe, according to standard industry practice?
- Within 7 calendar days of becoming aware
- Within 15 calendar days for serious and unexpected adverse events (Correct answer)
- Within 30 calendar days of the next quarterly report
- Within 24 hours only for fatal events; 30 days for non-fatal events
Correct answer: Within 15 calendar days for serious and unexpected adverse events
FDA regulations require expedited reporting of serious and unexpected adverse drug reactions within 15 calendar days of when the company becomes aware.
CNPR Compliance and Ethics 5
Which of the following correctly describes the difference between 'promotion' and 'education' in pharmaceutical industry standards?