CNPR Compliance and Ethics 3 — Questions and Answers
Question 1: A pharmaceutical representative is asked by a physician about a drug's use in a pediatric population, but the drug is only approved for adults. The representative should:
- Provide all available pediatric study data to help the physician
- Decline to discuss it and refer the physician to the company's medical information department (Correct answer)
- Share only the most favorable pediatric data available
- Advise the physician to call the FDA directly for guidance
Correct answer: Decline to discuss it and refer the physician to the company's medical information department
Off-label inquiries should be referred to the company's medical information or medical affairs team, who can respond appropriately within regulatory bounds.
Question 2: Under the False Claims Act, a whistleblower (relator) who exposes pharmaceutical fraud against the government may receive what percentage of the government's recovery?
- 1–5%
- 5–10%
- 15–30% (Correct answer)
- 35–50%
Correct answer: 15–30%
Under the False Claims Act's qui tam provisions, relators are entitled to 15–30% of the government's recovery, depending on their contribution to the case.
Question 3: Which of the following is an example of an acceptable educational grant in the pharmaceutical industry?
- A grant given to a physician's practice with no educational requirement
- An unrestricted grant to a medical school to fund an independent CME program (Correct answer)
- A grant conditioned on prescribers attending the company's promotional dinner
- A grant paid directly to a physician for their personal professional development
Correct answer: An unrestricted grant to a medical school to fund an independent CME program
Unrestricted educational grants to independent medical organizations for legitimate CME programs are permissible, as the company does not control the content.
Question 4: Which regulation requires pharmaceutical companies to maintain records of all promotional materials and submit them to the FDA at the time of first use?
- 21 CFR Part 202 (Correct answer)
- 21 CFR Part 312
- 21 CFR Part 314
- 21 CFR Part 820
Correct answer: 21 CFR Part 202
21 CFR Part 202 governs prescription drug advertising and requires companies to submit promotional materials to FDA's Office of Prescription Drug Promotion (OPDP) at first use.
Question 5: A healthcare provider requests a 'speaker honorarium' for a dinner program but wants to invite fewer than 5 attendees. The representative should:
- Approve the event since the physician is a high prescriber
- Require a minimum attendance that justifies an educational program format (Correct answer)
- Pay the honorarium regardless of attendance since it's for their time
- Offer a higher honorarium to make up for the small audience
Correct answer: Require a minimum attendance that justifies an educational program format
Speaker programs must have a legitimate educational purpose, which typically requires a reasonable minimum audience; events with very few attendees may not meet this standard.
Question 6: The CNPR certification demonstrates that a pharmaceutical representative has mastered knowledge of:
- Insurance billing procedures and Medicare coding
- Physiology, pharmacology, and federal regulations governing pharmaceutical sales (Correct answer)
- Hospital supply chain management and GPO contracting
- Clinical trial design and FDA drug approval processes only
Correct answer: Physiology, pharmacology, and federal regulations governing pharmaceutical sales
The CNPR certification covers physiology, pharmacology, diseases/conditions, and federal regulations relevant to ethical pharmaceutical sales.
Question 7: Which of the following describes a 'nominal value' item that may still be provided to healthcare professionals under the PhRMA Code?
- A $25 gift card to a bookstore
- A branded coffee mug worth $8
- A $20 branded tote bag
- Pens, notepads, and other items worth less than $10 per item that primarily benefit patients (Correct answer)
Correct answer: Pens, notepads, and other items worth less than $10 per item that primarily benefit patients
The PhRMA Code permits items of minimal value (under $10) that primarily benefit patients, such as patient education materials, but not personal gifts.
CNPR Compliance and Ethics 3
A pharmaceutical representative is asked by a physician about a drug's use in a pediatric population, but the drug is only approved for adults.
The representative should: