CNPR Regulatory Compliance & Ethical Standards 2 — Questions and Answers
Question 1: Under the Prescription Drug Marketing Act (PDMA), which activity is strictly prohibited for pharmaceutical sales representatives?
- Providing FDA-approved sample medications to licensed practitioners
- Reselling or trading prescription drug samples (Correct answer)
- Discussing on-label product indications with physicians
- Attending medical conferences with product literature
Correct answer: Reselling or trading prescription drug samples
PDMA prohibits the sale, purchase, or trading of prescription drug samples, as samples must be distributed only to licensed practitioners for patient use.
Question 2: The PhRMA Code on Interactions with Healthcare Professionals limits the value of educational items a representative may provide to a healthcare professional to:
- $25 or less (Correct answer)
- $50 or less
- $100 or less
- There is no monetary limit
Correct answer: $25 or less
The PhRMA Code restricts educational items or practice-related items to those worth $25 or less and that are directly beneficial to patient care.
Question 3: A pharmaceutical rep is asked by a physician about using a drug at a dose higher than what is listed in the FDA-approved labeling. The rep should:
- Explain the higher dose based on personal clinical knowledge
- Decline to discuss and refer the physician to medical affairs for an unsolicited inquiry (Correct answer)
- Share anecdotal reports from other physicians without citing sources
- Provide the physician with competitor trial data instead
Correct answer: Decline to discuss and refer the physician to medical affairs for an unsolicited inquiry
Off-label promotion is prohibited; reps should direct unsolicited off-label questions to the medical affairs team who can respond appropriately.
Question 4: Which federal law requires pharmaceutical manufacturers to track and record all sample distributions made by their sales representatives?
- Sarbanes-Oxley Act
- Prescription Drug Marketing Act (PDMA) (Correct answer)
- Foreign Corrupt Practices Act
- Health Insurance Portability and Accountability Act (HIPAA)
Correct answer: Prescription Drug Marketing Act (PDMA)
PDMA requires manufacturers to maintain detailed records of all sample distributions, including recipient signatures and quantities, to prevent diversion.
Question 5: When a pharmaceutical sales rep receives a report of a serious adverse event from a healthcare provider during a sales call, the rep's first obligation is to:
- Advise the physician on how to manage the side effect
- Reassure the physician that the event is unrelated to the drug
- Document and report the event to the company's pharmacovigilance department promptly (Correct answer)
- Wait until the next sales cycle to report non-urgent events
Correct answer: Document and report the event to the company's pharmacovigilance department promptly
FDA regulations require manufacturers to collect and submit serious adverse event reports; reps are the frontline reporters and must escalate immediately.
Question 6: The Sunshine Act (Open Payments Program) requires pharmaceutical manufacturers to publicly report payments to physicians above what threshold?
- $10 per transaction or $100 aggregate annually (Correct answer)
- $50 per transaction or $200 aggregate annually
- $100 per transaction or $500 aggregate annually
- All payments regardless of amount
Correct answer: $10 per transaction or $100 aggregate annually
Under the Sunshine Act, transfers of value exceeding $10 per transaction or $100 aggregate per year per covered recipient must be reported to CMS.
Question 7: A sales representative who knowingly promotes a drug for an unapproved indication may expose their company to liability under which legal framework?
- Federal Trade Commission Act only
- False Claims Act and the Food, Drug, and Cosmetic Act (Correct answer)
- Americans with Disabilities Act
- Lanham Act trademark provisions
Correct answer: False Claims Act and the Food, Drug, and Cosmetic Act
Off-label promotion can trigger FCA liability if it leads to false Medicare/Medicaid claims, and violates the FDCA's misbranding provisions.
CNPR Regulatory Compliance & Ethical Standards 2
Under the Prescription Drug Marketing Act (PDMA), which activity is strictly prohibited for pharmaceutical sales representatives?