MCQ Quiz: FDA Drug Policy

The U.S. Food and Drug Administration (FDA) is the primary federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of our nation’s drug supply. Understanding FDA drug policy, a cornerstone of the Principles of Pharmacy Law and Ethics course, is essential for every pharmacist to practice legally and ethically. This quiz will test your knowledge on the key legislation that has shaped the FDA’s authority, the rigorous drug approval process, and post-marketing safety programs like MedWatch and REMS.

1. The primary mission of the U.S. Food and Drug Administration (FDA) is to:

• a. Set the prices of prescription medications.
• b. Protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
• c. Regulate the practice of pharmacy in each state.
• d. Enforce the Controlled Substances Act.

Answer: b. Protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

2. Which landmark piece of legislation required that all new drugs be proven effective for their intended use before being marketed?

• a. The Pure Food and Drug Act of 1906
• b. The Food, Drug, and Cosmetic Act of 1938
• c. The Durham-Humphrey Amendment of 1951
• d. The Kefauver-Harris Amendment of 1962

Answer: d. The Kefauver-Harris Amendment of 1962

3. The Durham-Humphrey Amendment of 1951 is most famous for:

• a. Requiring all drugs to be proven safe.
• b. Establishing the two classes of drugs: prescription (legend) and over-the-counter (OTC).
• c. Creating the FDA.
• d. Regulating dietary supplements.

Answer: b. Establishing the two classes of drugs: prescription (legend) and over-the-counter (OTC).

4. Before a company can begin human clinical trials on a new drug, it must submit what type of application to the FDA?

• a. New Drug Application (NDA)
• b. Abbreviated New Drug Application (ANDA)
• c. Investigational New Drug (IND) application
• d. Supplemental New Drug Application (sNDA)

Answer: c. Investigational New Drug (IND) application

5. What is the primary purpose of a Phase 1 clinical trial?

• a. To determine the efficacy of the drug in a large patient population.
• b. To assess the safety, tolerability, and pharmacokinetic profile of a drug in a small group of healthy volunteers.
• c. To compare the new drug to the current standard of care.
• d. To conduct post-marketing surveillance.

Answer: b. To assess the safety, tolerability, and pharmacokinetic profile of a drug in a small group of healthy volunteers.

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

• a. True
• b. False

Answer: a. True

7. Which phase of clinical trials involves the largest number of patients and is designed to confirm efficacy and monitor for long-term adverse events before approval?

• a. Phase 1
• b. Phase 2
• c. Phase 3
• d. Phase 4

Answer: c. Phase 3

8. The FDA’s MedWatch program is a system for:

• a. Patients to get discounts on medications.
• b. Voluntary reporting of adverse drug events and medication errors.
• c. Approving new drugs.
• d. Regulating medical devices only.

Answer: b. Voluntary reporting of adverse drug events and medication errors.

9. A Risk Evaluation and Mitigation Strategy (REMS) may be required by the FDA for a drug with:

• a. A very safe profile.
• b. Serious safety concerns, to ensure the benefits of the drug outweigh the risks.
• c. A generic version available.
• d. Low efficacy.

Answer: b. Serious safety concerns, to ensure the benefits of the drug outweigh the risks.

10. What is the purpose of an Abbreviated New Drug Application (ANDA)?

• a. To get approval for a new investigational drug.
• b. To get approval to market a generic version of a brand-name drug.
• c. To get approval for a new indication for an existing drug.
• d. To report an adverse event.

Answer: b. To get approval to market a generic version of a brand-name drug.

11. The “How New Drugs are Developed” module is part of the Medicinal Chemistry and Pharmacology course.

• a. True
• b. False

Answer: a. True

12. To be approved, a generic drug must be shown to be ________ to the brand-name product.

• a. chemically identical
• b. therapeutically superior
• c. bioequivalent
• d. less expensive

Answer: c. bioequivalent

13. The FDA’s “Orange Book” provides information on:

• a. The price of medications.
• b. Approved drug products with therapeutic equivalence evaluations.
• c. Herbal supplements.
• d. Compounding formulas.

Answer: b. Approved drug products with therapeutic equivalence evaluations.

14. A drug recall that involves a product that may cause temporary or medically reversible adverse health consequences is classified as a:

• a. Class I Recall
• b. Class II Recall
• c. Class III Recall
• d. Class IV Recall

Answer: b. Class II Recall

15. Counseling patients on medication safety is a key role for a pharmacist.

• a. True
• b. False

Answer: a. True

16. The Dietary Supplement Health and Education Act of 1994 (DSHEA) regulates dietary supplements as:

• a. Drugs
• b. A special category of food
• c. Medical devices
• d. Cosmetics

Answer: b. A special category of food

17. Under DSHEA, a dietary supplement manufacturer must prove their product is effective before marketing it.

• a. True
• b. False

Answer: b. False

18. The new Pregnancy and Lactation Labeling Rule (PLLR) was designed to:

• a. Assign a simple letter grade for safety.
• b. Provide a more detailed and useful narrative summary of risks for clinicians.
• c. Make labeling requirements less strict.
• d. Apply only to over-the-counter medications.

Answer: b. Provide a more detailed and useful narrative summary of risks for clinicians.

19. A “black box warning” in a drug’s package insert is:

• a. The strongest safety warning that the FDA can require.
• b. Information about the drug’s mechanism of action.
• c. A list of all possible side effects.
• d. The indication for the drug.

Answer: a. The strongest safety warning that the FDA can require.

20. A “Medication Guide” is an FDA-approved patient handout that is required for certain drugs with:

• a. A very simple dosing schedule.
• b. Serious and significant public health concerns.
• c. A low risk of side effects.
• d. No generic available.

Answer: b. Serious and significant public health concerns.

21. The regulation of dietary supplements is a topic within the Patient Care I curriculum.

• a. True
• b. False

Answer: a. True

22. Direct-to-consumer (DTC) advertising of prescription drugs is regulated by:

• a. The Federal Trade Commission (FTC)
• b. The Centers for Disease Control and Prevention (CDC)
• c. The Food and Drug Administration (FDA)
• d. It is not regulated.

Answer: c. The Food and Drug Administration (FDA)

23. The “Bad Ad” program is an FDA initiative that allows healthcare professionals to report:

• a. Misleading or inaccurate prescription drug advertising.
• b. Rude behavior by a pharmaceutical sales representative.
• c. High drug prices.
• d. Drug shortages.

Answer: a. Misleading or inaccurate prescription drug advertising.

24. The concept of Medication Safety is a module in the Patient Care 5 course.

• a. True
• b. False

Answer: a. True

25. A key difference between a drug and a dietary supplement is that:

• a. A drug is intended to diagnose, cure, mitigate, treat, or prevent disease.
• b. A supplement can only make “structure/function” claims.
• c. A drug must undergo rigorous clinical trials for approval.
• d. All of the above.

Answer: d. All of the above.

26. “Off-label” prescribing refers to a physician prescribing a medication:

• a. For an unapproved indication.
• b. At a different dose than what is approved.
• c. In a different patient population than what is approved.
• d. All of the above.

Answer: d. All of the above.

27. Is it legal for a physician to prescribe a drug for an off-label use?

• a. No, it is illegal.
• b. Yes, it is a common and legal practice based on their professional judgment.
• c. Only in a hospital setting.
• d. Only for non-controlled substances.

Answer: b. Yes, it is a common and legal practice based on their professional judgment.

28. An “orphan drug” is a drug that is:

• a. Developed to treat a rare disease affecting a small patient population.
• b. No longer protected by a patent.
• c. Only available in other countries.
• d. Has no known mechanism of action.

Answer: a. Developed to treat a rare disease affecting a small patient population.

29. What is the role of an Institutional Review Board (IRB) in the drug approval process?

• a. To review and approve the marketing plan for a new drug.
• b. To ensure the rights and welfare of human subjects participating in clinical trials are protected.
• c. To set the price of the investigational drug.
• d. To analyze the statistical data from the trial.

Answer: b. To ensure the rights and welfare of human subjects participating in clinical trials are protected.

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

• a. True
• b. False

Answer: a. True

31. After a drug is approved, the FDA’s role in monitoring its safety continues through:

• a. Phase 1 trials
• b. Phase 2 trials
• c. Phase 3 trials
• d. Phase 4 trials and post-marketing surveillance.

Answer: d. Phase 4 trials and post-marketing surveillance.

32. The “A/B” rating in the Orange Book indicates that two products are:

• a. Not therapeutically equivalent.
• b. Considered therapeutically equivalent.
• c. Still under patent protection.
• d. Biologic agents.

Answer: b. Considered therapeutically equivalent.

33. The concept of a “sentinel event” is often related to medication safety and is defined by:

• a. The Joint Commission (TJC)
• b. The Food and Drug Administration (FDA)
• c. The Drug Enforcement Administration (DEA)
• d. The Board of Pharmacy (BOP)

Answer: a. The Joint Commission (TJC)

34. A pharmacist’s role in FDA drug policy includes:

• a. Reporting adverse drug events to MedWatch.
• b. Staying informed about new drug approvals and safety warnings.
• c. Educating patients about REMS programs.
• d. All of the above.

Answer: d. All of the above.

35. The Food, Drug, and Cosmetic Act of 1938 was passed in response to a tragedy involving which product?

• a. Thalidomide
• b. An elixir of sulfanilamide prepared with a toxic solvent.
• c. A contaminated vaccine.
• d. An adulterated patent medicine.

Answer: b. An elixir of sulfanilamide prepared with a toxic solvent.

36. A drug company is not allowed to promote a drug for an off-label use.

• a. True
• b. False

Answer: a. True

37. Which of the following is a potential component of a REMS program?

• a. A communication plan for healthcare providers.
• b. Elements to Assure Safe Use (ETASU), such as patient registries or special certification for prescribers.
• c. A Medication Guide.
• d. All of the above.

Answer: d. All of the above.

38. The “Introduction to Medication Errors” is a module within the Professional Practice Skills Lab II.

• a. True
• b. False

Answer: a. True

39. A “biologic” medication, like a monoclonal antibody, is approved via a(n):

• a. NDA
• b. ANDA
• c. BLA (Biologics License Application)
• c. IND

Answer: c. BLA (Biologics License Application)

40. A “biosimilar” is to a biologic as a “_____” is to a small molecule drug.

• a. brand name drug
• b. generic drug
• c. new chemical entity
• d. prodrug

Answer: b. generic drug

41. The FDA has authority over:

• a. The practice of medicine and pharmacy.
• b. The approval and regulation of drug products.
• c. The reimbursement rates for drugs.
• d. The scheduling of controlled substances.

Answer: b. The approval and regulation of drug products.

42. A Class I recall is the most serious type, involving a product that has a reasonable probability of causing:

• a. No health consequences.
• b. Temporary or minor health consequences.
• c. Serious adverse health consequences or death.
• d. Only an economic loss.

Answer: c. Serious adverse health consequences or death.

43. A key skill for a pharmacist is to be able to critically evaluate:

• a. The evidence supporting a new drug’s approval.
• b. The claims made in drug advertising.
• c. The safety profile of a medication.
• d. All of the above.

Answer: d. All of the above.

44. What is the primary purpose of a “fast track” or “breakthrough therapy” designation from the FDA?

• a. To make drug development more expensive.
• b. To expedite the development and review of drugs for serious conditions that fill an unmet medical need.
• c. To allow manufacturers to skip Phase 3 trials.
• d. To guarantee a drug’s approval.

Answer: b. To expedite the development and review of drugs for serious conditions that fill an unmet medical need.

45. Pharmacists are legally obligated to provide counseling on new prescriptions in many states, a policy influenced by:

• a. The FDA
• b. The DEA
• c. OBRA ’90
• d. The Kefauver-Harris Amendment

Answer: c. OBRA ’90

46. The Purple Book is a resource for identifying:

• a. Therapeutically equivalent small molecule drugs.
• b. Licensed biological products and their biosimilars.
• c. Approved veterinary drugs.
• d. Drugs with REMS programs.

Answer: b. Licensed biological products and their biosimilars.

47. The curriculum includes a dedicated course on Pharmacy Law and Ethics.

• a. True
• b. False

Answer: a. True

48. A drug’s “indication” is:

• a. Its mechanism of action.
• b. Its side effect profile.
• c. The specific condition it is FDA-approved to treat.
• d. Its chemical structure.

Answer: c. The specific condition it is FDA-approved to treat.

49. The overall purpose of FDA drug policy is to:

• a. Create barriers to new drug development.
• b. Ensure that the drugs available to the public are safe and effective for their intended use.
• c. Control the price of medications.
• d. Promote the use of brand-name drugs over generics.

Answer: b. Ensure that the drugs available to the public are safe and effective for their intended use.

50. The ultimate reason for a pharmacist to have a strong understanding of FDA drug policy is to:

• a. Practice legally and ethically.
• b. Protect the public health.
• c. Act as an effective drug information expert.
• d. All of the above.

Answer: d. All of the above.