CNPR Regulatory Compliance & Ethical Standards 3 — Questions and Answers
Question 1: Which organization publishes the voluntary code of conduct most widely adopted by US pharmaceutical companies for interactions with healthcare professionals?
- FDA Center for Drug Evaluation and Research
- Pharmaceutical Research and Manufacturers of America (PhRMA) (Correct answer)
- American Medical Association (AMA)
- Centers for Medicare & Medicaid Services (CMS)
Correct answer: Pharmaceutical Research and Manufacturers of America (PhRMA)
PhRMA publishes the 'Code on Interactions with Healthcare Professionals,' which sets voluntary ethical standards for pharmaceutical marketing practices.
Question 2: Under HIPAA, when a pharmaceutical representative visits a physician's office and overhears protected health information about a patient, the rep must:
- Document the information for later reference in sales planning
- Disclose it to their manager as a potential market opportunity
- Treat the information as strictly confidential and not use or disclose it (Correct answer)
- Report it to the FDA as a potential adverse event
Correct answer: Treat the information as strictly confidential and not use or disclose it
HIPAA protects patient health information; even incidentally overheard PHI must not be used or disclosed by pharmaceutical representatives.
Question 3: A pharmaceutical company's medical science liaison (MSL) differs from a sales representative primarily because MSLs are permitted to:
- Discuss off-label data proactively without restrictions
- Engage in reactive scientific exchange with KOLs about unpublished data within company guidelines (Correct answer)
- Set their own prescribing recommendations
- Bypass FDA requirements for new drug applications
Correct answer: Engage in reactive scientific exchange with KOLs about unpublished data within company guidelines
MSLs operate in a medical/scientific rather than commercial capacity and can respond to unsolicited off-label inquiries, unlike sales representatives.
Question 4: Which document must a physician sign each time a pharmaceutical sales representative leaves drug samples at an office?
- A prescription pad receipt
- A sample receipt acknowledgment required by PDMA (Correct answer)
- A patient consent form
- An IND application waiver
Correct answer: A sample receipt acknowledgment required by PDMA
PDMA requires that a licensed practitioner sign a receipt for each sample delivery, which manufacturers must retain as part of their sample accountability records.
Question 5: The concept of 'fair balance' in pharmaceutical promotion requires that promotional materials:
- Present only the drug's benefits to maximize prescriber interest
- Include risk information in a comparable manner to efficacy claims (Correct answer)
- Always use identical font size for benefits and risks
- Be approved by an independent ethics committee before distribution
Correct answer: Include risk information in a comparable manner to efficacy claims
FDA requires that promotional materials present a fair balance of information about risks and benefits so that the net impression is not misleading.
Question 6: Corporate integrity agreements (CIAs) are typically entered into between pharmaceutical companies and which federal entity following a compliance violation?
- FDA's Office of Criminal Investigations
- Office of Inspector General (OIG) of the Department of Health and Human Services (Correct answer)
- Department of Justice Antitrust Division
- Federal Trade Commission
Correct answer: Office of Inspector General (OIG) of the Department of Health and Human Services
The OIG negotiates CIAs with companies as an alternative to exclusion from federal healthcare programs, requiring enhanced compliance oversight.
Question 7: A sales representative is offered a large speaking fee by a hospital to present about their product. According to PhRMA guidelines, this arrangement raises concerns primarily because:
- Sales reps are not permitted to speak publicly about any pharmaceutical product
- Speaking fees to reps can be seen as disguised payments for prescribing activity (Correct answer)
- Hospital presentations require FDA pre-approval
- Only MDs are permitted to receive speaker fees from manufacturers
Correct answer: Speaking fees to reps can be seen as disguised payments for prescribing activity
PhRMA guidelines caution that payments to sales representatives for speaking engagements can appear to reward prescribing behavior rather than reflect legitimate educational value.
CNPR Regulatory Compliance & Ethical Standards 3
Which organization publishes the voluntary code of conduct most widely adopted by US pharmaceutical companies for interactions with healthcare professionals?