Regulatory Compliance & Ethical Standards Flashcards
7 cards from real CNPR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Ethical Standards flashcards as text
The FDA's regulations on pharmaceutical advertising distinguish between 'reminder ads' and 'full product ads' primarily in that reminder ads:
Answer: Name the product and its drug class but do not make efficacy or risk claims
Reminder ads are exempt from the full brief summary requirement because they only state the product name and do not include any claims about the drug's use or benefits.
Anti-kickback statute violations in pharmaceutical sales typically involve providing something of value to a healthcare provider with the intent to:
Answer: Induce or reward referrals or prescriptions paid for by federal healthcare programs
The Anti-Kickback Statute (AKS) prohibits giving, offering, or receiving anything of value intended to generate business reimbursable by federal healthcare programs.
When a pharmaceutical company conducts a speaker program for physicians, which of the following activities is prohibited under the PhRMA Code?
Answer: Holding the event at a resort or entertainment venue
PhRMA guidelines require that speaker programs be held in venues conducive to informational exchange, excluding resorts, sporting events, or entertainment venues.
Under FDA regulations, a pharmaceutical representative's verbal statements during a sales call are held to the same standard as:
Answer: Written promotional materials requiring fair balance and truthfulness
The FDA considers all promotional communications — verbal or written — to be subject to the same truthfulness, fair balance, and non-misleading standards.
Which of the following best describes the 'learned intermediary doctrine' as it applies to pharmaceutical representatives?
Answer: Manufacturers discharge their duty to warn by providing adequate information to prescribing physicians rather than directly to patients
The learned intermediary doctrine holds that adequate warnings to the prescribing physician satisfy the manufacturer's duty to warn, since the physician acts as the expert intermediary.
A pharmaceutical company's compliance program is considered effective under OIG guidance if it includes all of the following EXCEPT:
Answer: Guaranteed immunity from prosecution for all violations
Effective compliance programs include policies, training, auditing, and reporting mechanisms, but having a program does not grant immunity from prosecution.
A pharmaceutical representative who suspects a colleague is falsifying sample accountability records should first:
Answer: Report the concern through the company's compliance hotline or to a compliance officer
Internal compliance reporting channels are the appropriate first step; most companies have confidential hotlines specifically for reporting potential violations.