CNPR Compliance and Ethics 3

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:

Accepted Answer

Decline to discuss it and refer the physician to the company's medical information department

Answer

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?

Accepted Answer

15–30%

Answer

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?

Accepted Answer

An unrestricted grant to a medical school to fund an independent CME program

Answer

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?

Accepted Answer

21 CFR Part 202

Answer

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:

Accepted Answer

Require a minimum attendance that justifies an educational program format

Answer

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.

(CNPR) Certified National Pharmaceutical Representative Practice Test

(CNPR) Certified National Pharmaceutical Representative Practice Test

CNPR Compliance and Ethics 3