Question

1. The Federal Trade Commission (FTC) and Food and Drug Administration are responsible for federal regulation of the promotion of most commercial products. Which agency regulates drug advertising?
A. The FDA regulates both direct-to-consumer prescription drug promotions and OTC drugs.
B. The FTC regulates both direct-to-consumer prescription drug and OTC drugs.
C. The FDA regulates prescription drug promotion while the FTC regulates OTC drug promotion.
D. The FDA regulates prescription drug promotion and shares responsibility for OTC drugs with the FTC.

2. How does the regulation of DTC prescription drug advertising differ between the U.S. and Europe?
A. Europe permits DTC advertising but only if the manufacturer is located within a country belonging to the European Union.
B. Europe permits DTC advertising of a small group of drugs used for chronic diseases.
C. Europe has very few restrictions on DTC advertising relying on health professionals to provide guidance.
D. Europe does not permit any DTC drug advertising.

3. What did the first televised direct-to-consumer TV ad for a prescription drug promote?
A. Sildenafil
B. Ibuprofen
C. Atorvastatin
D. Minoxidil

4. Which of the following is a requirement for DTC prescription ads?
A. A listing of only serious adverse effects in any ad for a prescription drug.
B. A complete list of all known adverse effects in ads that mentions a drug by name.
C. A drug that carries a “boxed” warning cannot be advertised.
D. A listing of all adverse effects found in the approved prescribing information.

5. What must a manufacturer do when running a DTC prescription drug ad?
A. Submit the ad to the FDA for approval before it is run and wait for approval.
B. Submit the warning statement included in the ad to the FDA before it is run.
C. Identify the target audience and tell FDA who it targets before running the ad.
D. Submit the ad to the FDA before the first airing but approval is not required.

6. The Pure Food and Drug Act of 1906 first introduced a means to regulate drug promotion. Why was it relatively unsuccessful?
A. The Supreme Court ruled that the law did not prohibit false therapeutic claims.
B. There was no federal agency empowered to enforce the law at the time.
C. The law dealt primarily with adulterated foods and paid insufficient attention to drugs.
D. The Supreme Court said it violated the First Amendment.

7. The Food, Drug, and Cosmetic Act (FDCA) was a milestone in providing effective risk information. What did its implementation do?
A. It required patient package inserts to list all serious adverse effects.
B. It required ads directed at prescribers to list all adverse effects.
C. It expanded the definition of misbranding to mandate adequate directions for use and warnings.
D. It created the “boxed” warning.

8. What effect did the Durham-Humphrey Amendment have on prescription drug advertising?
A. It required promotions using audio and visual communication systems to briefly summarize all necessary information related to adverse effects and contraindications.
B. It permitted advertising of prescription drugs in newspapers which led to expansion of drug promotion.
C. It gave the FDA authority to regulate ads in medical journals.
D. It expressly prohibited advertising on TV.

9. In 2015, a famous social media personality posted about her experience managing her morning sickness with a prescription drug. What did the FDA do in response to this activity?
A. They sent a warning letter to the celebrity requesting her to identify her financial relationship with the manufacturer.
B. They sent a warning letter to the manufacturer stating that the risk information in the post was inadequate.
C. They demanded that the post be removed.
D. They sent the celebrity a letter expressing appreciation for informing the public about this issue.

10. Sen. Dick Durbin has introduced a bill in Congress that would modify prescription drug promotion. What would this bill, if passed, do?
A. It would prohibit promotion of off-label drug uses.
B. It would prohibit DTC advertising on the internet.
C. It would close a loophole in advertising by subjecting social media influencers to a penalty if they make a false or misleading statement about a drug.
D. Require DTC ads to contain information about drug costs.

Answer 1

Here are the answers (with brief notes):

1. C — The FDA regulates prescription drug promotion; the FTC regulates OTC drug advertising.
2. D — Europe generally prohibits direct-to-consumer advertising of prescription medicines.
3. D — The first televised DTC prescription‑drug ad promoted minoxidil (Rogaine).
4. A — DTC prescription ads must disclose the major (serious) risks/contraindications (a “major statement”/fair balance).
5. D — Ads must be submitted to FDA (at the time of initial dissemination; approval prior to airing is not required).
6. A — The Supreme Court interpreted the 1906 Act as not covering false therapeutic claims, limiting its effectiveness.
7. C — The FDCA expanded the definition of misbranding to require adequate directions for use and warnings.
8. C — The Durham‑Humphrey Amendment established the prescription/OTC distinction and affected advertising directed to professionals (giving FDA authority over ads in professional channels such as medical journals).
9. B — The FDA sent a warning letter to the manufacturer, stating the risk information in the celebrity’s post was inadequate.
10. C — The Durbin bill would close a loophole by making social‑media influencers subject to penalties if they make false or misleading drug claims.