MCQ Quiz: Marketing Unapproved Drugs

The marketing and promotion of drugs in the United States is a highly regulated process overseen by the FDA to protect public health. A cornerstone of this regulation, a key topic in the Principles of Pharmacy Law and Ethics course “, is the strict prohibition against manufacturers marketing unapproved drugs or unapproved (“off-label”) uses of their products. This quiz will test your knowledge on the legal and ethical principles governing pharmaceutical promotion, the critical distinction between promotion and prescribing, and the pharmacist’s role in this complex environment.

1. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for a pharmaceutical manufacturer to

• a. Prescribe a medication.
• b. Market a drug for an indication that has not been approved by the FDA.
• c. Provide samples of a non-controlled substance to a physician.
• d. Conduct post-marketing surveillance.

Answer: b. Market a drug for an indication that has not been approved by the FDA.

2. A drug that is promoted by its manufacturer for an unapproved use is considered legally:

• a. Adulterated
• b. A controlled substance
• c. Misbranded
• d. A generic equivalent

Answer: c. Misbranded

3. Which of the following statements correctly describes the difference between off-label prescribing and off-label promotion?

• a. Off-label prescribing by a physician is illegal, but off-label promotion by a manufacturer is legal.
• b. Both are legal and unregulated activities.
• c. Off-label prescribing by a physician is a legal practice, but off-label promotion by a manufacturer is illegal.
• d. Both are illegal and subject to criminal charges.

Answer: c. Off-label prescribing by a physician is a legal practice, but off-label promotion by a manufacturer is illegal.

4. A pharmaceutical sales representative visits a physician’s office and provides information about using their company’s antidepressant for weight loss, an unapproved indication. This activity is:

• a. An example of evidence-based practice.
• b. A legal and appropriate educational activity.
• c. An example of illegal off-label promotion.
• d. Permissible if the physician asks for the information first.

Answer: c. An example of illegal off-label promotion.

5. The FDA’s new drug approval process, which a drug must complete to be legally marketed for an indication, is a topic in which course?

• a. PHA5439 Principles of Medicinal Chemistry and Pharmacology I
• b. PHA5104 Sterile Compounding
• c. PHA5787C Patient Care 5
• d. PHA5176 Drug Delivery Systems

Answer: a. PHA5439 Principles of Medicinal Chemistry and Pharmacology I

6. Under the Dietary Supplement Health and Education Act (DSHEA), a manufacturer can market a supplement with which of the following claims?

• a. “Cures irritable bowel syndrome.”
• b. “Prevents heart disease.”
• c. “Treats osteoporosis.”
• d. “Helps support bone health.”

Answer: d. “Helps support bone health.”

7. A dietary supplement label must contain which disclaimer?

• a. “This product is approved by the FDA.”
• b. “This statement has not been evaluated by the Food and Drug Administration.”
• c. “This product is 100% safe.”
• d. “This product is more effective than prescription drugs.”

Answer: b. “This statement has not been evaluated by the Food and Drug Administration.”

8. A physician may legally prescribe a medication for an off-label indication based on:

• a. Their professional judgment and sound scientific evidence.
• b. A patient’s request only.
• c. A conversation with a pharmaceutical sales representative.
• d. A television commercial.

Answer: a. Their professional judgment and sound scientific evidence.

9. The FDA’s “Bad Ad” program encourages healthcare professionals to:

• a. Create their own advertisements for drugs.
• b. Report misleading or illegal prescription drug promotion.
• c. Review advertisements for over-the-counter products.
• d. Participate in drug marketing focus groups.

Answer: b. Report misleading or illegal prescription drug promotion.

10. What is the pharmacist’s professional responsibility when they receive a prescription for an off-label use?

• a. To refuse to fill all off-label prescriptions.
• b. To dispense the prescription without question.
• c. To use their professional judgment to assess the appropriateness and safety of the intended use for that specific patient.
• d. To report the prescriber to the FDA.

Answer: c. To use their professional judgment to assess the appropriateness and a safety of the intended use for that specific patient.

11. The federal regulation of dietary supplements is a topic covered in the Patient Care I curriculum.

• a. True
• b. False

Answer: a. True

12. It is permissible for a manufacturer’s Medical Science Liaison (MSL) to provide peer-reviewed articles about an off-label use to a physician if:

• a. The physician makes an unsolicited request for the information.
• b. The MSL is also a licensed physician.
• c. The article was published in the last month.
• d. The information is provided during a sponsored dinner program.

Answer: a. The physician makes an unsolicited request for the information.

13. A drug that has not gone through the NDA process is considered a(n):

• a. Generic drug
• b. Unapproved new drug
• c. Counterfeit drug
• d. Bioequivalent drug

Answer: b. Unapproved new drug

14. A key reason for the strict regulation of drug marketing is to ensure that healthcare decisions are based on:

• a. The manufacturer’s marketing budget.
• b. The persuasiveness of a sales representative.
• c. Scientific evidence of safety and efficacy.
• d. Patient testimonials from commercials.

Answer: c. Scientific evidence of safety and efficacy.

15. The “Principles of Pharmacy Law and Ethics” is a core course in the curriculum.

• a. True
• b. False

Answer: a. True

16. Which of the following is an example of illegal off-label promotion?

• a. A journal article discussing an off-label use of a drug.
• b. A physician presenting a case study on an off-label use at a medical conference.
• c. A drug company sponsoring a speaker to promote their drug for an unapproved indication.
• d. A pharmacist answering a question from a physician about an off-label use.

Answer: c. A drug company sponsoring a speaker to promote their drug for an unapproved indication.

17. The primary difference in how drugs and dietary supplements are regulated is that:

• a. Drugs must be proven safe and effective pre-market, while supplements do not.
• b. Supplements are more tightly regulated than drugs.
• c. There is no difference in their regulation.
• d. The DEA regulates supplements, and the FDA regulates drugs.

Answer: a. Drugs must be proven safe and effective pre-market, while supplements do not.

18. A pharmacist who receives promotional materials from a manufacturer for an unapproved use of a drug should:

• a. Distribute them to patients.
• b. Use them to make clinical recommendations.
• c. Recognize them as potentially illegal marketing and discard them.
• d. Display them in the pharmacy.

Answer: c. Recognize them as potentially illegal marketing and discard them.

19. The concept of “misbranding” under the FD&C Act is a key topic in pharmacy law.

• a. True
• b. False

Answer: a. True

20. A pharmaceutical company can face what consequences for illegal off-label marketing?

• a. Large financial penalties.
• b. A Corporate Integrity Agreement (CIA).
• c. Criminal charges against company executives.
• d. All of the above.

Answer: d. All of the above.

21. A pharmacist can provide evidence-based information to a prescriber about an off-label use.

• a. True
• b. False

Answer: a. True

22. “Direct-to-Consumer” (DTC) advertising must include:

• a. A list of all the drug’s benefits.
• b. A “major statement” of the drug’s most important risks.
• c. A coupon for a discount.
• d. The chemical structure of the drug.

Answer: b. A “major statement” of the drug’s most important risks.

23. The principles of evidence-based practice are crucial for evaluating claims about medications.

• a. True
• b. False

Answer: a. True

24. A drug’s FDA-approved prescribing information, or package insert, is the primary source for its:

• a. Approved indications, dosing, and safety information.
• b. Potential off-label uses.
• c. Cost.
• d. International availability.

Answer: a. Approved indications, dosing, and safety information.

25. A pharmacist’s ethical duty is to:

• a. Promote the most profitable drugs.
• b. Provide truthful and evidence-based information to patients and providers, regardless of manufacturer promotion.
• c. Only dispense drugs for their FDA-approved indications.
• d. Follow the recommendations of sales representatives.

Answer: b. Provide truthful and evidence-based information to patients and providers, regardless of manufacturer promotion.

26. A manufacturer cannot legally provide financial incentives to physicians for prescribing their drug for an off-label use.

• a. True
• b. False

Answer: a. True

27. The term “unapproved drug” can refer to:

• a. A drug that has not completed the NDA process.
• b. A counterfeit medication.
• c. A drug imported from another country that is not FDA-approved.
• d. All of the above.

Answer: d. All of the above.

28. The main focus of the FDA’s regulation of drug promotion is to ensure:

• a. That advertisements are creative.
• b. That promotional materials are truthful and not misleading.
• c. That companies spend a lot of money on marketing.
• d. That only brand-name drugs are advertised.

Answer: b. That promotional materials are truthful and not misleading.

29. What is a key difference between a “structure/function” claim and a “disease” claim?

• a. A disease claim mentions a specific disease (e.g., “treats hypertension”), while a structure/function claim does not (e.g., “supports cardiovascular health”).
• b. There is no difference.
• c. Only drugs can make structure/function claims.
• d. Only supplements can make disease claims.

Answer: a. A disease claim mentions a specific disease (e.g., “treats hypertension”), while a structure/function claim does not (e.g., “supports cardiovascular health”).

30. The drug approval process is a topic in the Medicinal Chemistry and Pharmacology course.

• a. True
• b. False

Answer: a. True

31. A pharmacist is asked by a physician about using a drug off-label. The most appropriate action is to:

• a. Refuse to answer the question.
• b. Tell the physician it is illegal.
• c. Provide the physician with any available scientific evidence (e.g., clinical trials) regarding that specific use.
• d. Immediately call the drug’s manufacturer.

Answer: c. Provide the physician with any available scientific evidence (e.g., clinical trials) regarding that specific use.

32. The prohibition on marketing unapproved drugs is intended to protect the public from:

• a. Drugs that may be unsafe.
• b. Drugs that may be ineffective.
• c. Misleading health claims.
• d. All of the above.

Answer: d. All of the above.

33. The FDA’s Office of Prescription Drug Promotion (OPDP) is responsible for:

• a. Reviewing drug advertisements and promotional materials.
• b. Setting drug prices.
• c. Conducting Phase 1 clinical trials.
• d. Managing drug recalls.

Answer: a. Reviewing drug advertisements and promotional materials.

34. A continuing education program for pharmacists that is heavily biased and promotes a single drug for unapproved uses may be considered:

• a. A valid educational activity.
• b. A form of indirect promotion by the manufacturer.
• c. The best source of information.
• d. A requirement for licensure.

Answer: b. A form of indirect promotion by the manufacturer.

35. As a professional, a pharmacist should base their clinical recommendations on:

• a. Promotional materials from drug companies.
• b. The best available scientific evidence.
• c. The popularity of a drug.
• d. Anecdotes from other patients.

Answer: b. The best available scientific evidence.

36. The FDA has the authority to regulate social media posts made by pharmaceutical companies about their products.

• a. True
• b. False

Answer: a. True

37. Which of the following is NOT part of the new drug approval process?

• a. Investigational New Drug (IND) application
• b. Clinical trials
• c. New Drug Application (NDA)
• d. Marketing plan review and approval

Answer: d. Marketing plan review and approval

38. The “Medication Safety” module in Patient Care 5 would cover risks associated with inappropriate drug use, including off-label use.

• a. True
• b. False

Answer: a. True

39. A pharmacist’s primary ethical obligation is to:

• a. The pharmaceutical manufacturer.
• b. The patient’s well-being.
• c. The pharmacy’s profit margin.
• d. The prescribing physician.

Answer: b. The patient’s well-being.

40. A key skill for a pharmacist is to be able to:

• a. Differentiate between evidence-based information and marketing promotion.
• b. Design effective advertisements.
• c. Negotiate drug prices with manufacturers.
• d. Prescribe any medication they choose.

Answer: a. Differentiate between evidence-based information and marketing promotion.

41. The legal basis for the FDA’s authority over drug marketing comes from the:

• a. The U.S. Constitution.
• b. The Food, Drug, and Cosmetic Act.
• c. The Controlled Substances Act.
• d. The Social Security Act.

Answer: b. The Food, Drug, and Cosmetic Act.

42. A “reminder ad” is a type of advertisement that:

• a. Can state the drug’s name and indication.
• b. Must include all risk information.
• c. States the drug’s name but not its use, and is therefore exempt from including risk information.
• d. Is illegal in the United States.

Answer: c. States the drug’s name but not its use, and is therefore exempt from including risk information.

43. A pharmacist who reports misleading drug advertising to the FDA is:

• a. Violating the trust of the drug company.
• b. Fulfilling a professional role in protecting public health.
• c. Wasting their time.
• d. Breaking the law.

Answer: b. Fulfilling a professional role in protecting public health.

44. The fundamental reason it is illegal to market an unapproved drug is that:

• a. It has not been proven by the FDA to be safe and effective for its intended use.
• b. It is too expensive.
• c. It would create too much competition.
• d. The name is not catchy enough.

Answer: a. It has not been proven by the FDA to be safe and effective for its intended use.

45. Which of the following is an example of an “unapproved drug”?

• a. A generic version of Lipitor.
• b. A new chemical entity that has not undergone the NDA process.
• c. An OTC version of ibuprofen.
• d. A biosimilar for Humira.

Answer: b. A new chemical entity that has not undergone the NDA process.

46. A drug’s “label” or “labeling” legally includes:

• a. Only the sticker on the prescription vial.
• b. Only the package insert.
• c. All written, printed, or graphic matter accompanying the drug, including the package insert and container label.
• d. The television commercial for the drug.

Answer: c. All written, printed, or graphic matter accompanying the drug, including the package insert and container label.

47. The pharmacy law curriculum is designed to prepare students to practice legally and ethically.

• a. True
• b. False

Answer: a. True

48. If a manufacturer wants to market their drug for a new indication, they must submit a(n):

• a. Supplemental New Drug Application (sNDA).
• b. New IND.
• c. New ANDA.
• d. They can just start marketing it.

Answer: a. Supplemental New Drug Application (sNDA).

49. The overall regulatory framework for drug marketing in the U.S. is designed to:

• a. Make it easy for companies to sell their products.
• b. Ensure that claims made about drugs are supported by scientific evidence.
• c. Promote the use of dietary supplements.
• d. Limit patient access to information.

Answer: b. Ensure that claims made about drugs are supported by scientific evidence.

50. The ultimate goal of learning about the regulation of drug marketing is to:

• a. Be able to protect patients from misinformation and ensure medication use is based on sound science.
• b. Become a marketing executive for a drug company.
• c. Pass the MPJE.
• d. Appreciate the creativity of drug commercials.

Answer: a. Be able to protect patients from misinformation and ensure medication use is based on sound science.