How are Prescription Medication Advertisements Regulated in the U.S.?
Key takeaways:
The FDA regulates some aspects of drug advertising. Drug advertisements must not be misleading and are required to show a fair balance of benefits and risks.
Drug ads don’t have to share certain information. Ads may exclude how many people the medication has helped, or if there are other treatments with fewer side effects or lower prices. You may even see ads for drugs before they’ve been tested for safety.
The FDA typically doesn’t review drug ads until they’ve been released and doesn’t ban many. You can report ads you think are false, misleading, or biased to the FDA.
The regulation of drug advertisements in the U.S. has long been a source of conflict. Drug manufacturers and policy makers have been debating several issues — like whether ads should be approved before they’re aired and what they need to disclose about the effectiveness of medications.
There are both benefits and risks associated with direct-to-consumer drug ads. There are also ethical concerns around how advertising may influence medical decisions that should be made between a person and their healthcare provider.
Should drug companies be allowed to advertise? Let’s look at some facts below.
What is the purpose of drug advertising?
Drug company advertising is a controversial topic. Supporters of drug commercials believe that the ads educate people and help them take a more active part in their healthcare. Research suggests that people are more likely to talk to healthcare providers about their treatment and other health concerns.
Others are concerned that profits influence drug companies too much, and that drug advertising is harmful to people. Studies show that ads don’t provide enough information to make informed decisions. As a result, ads can influence them to request medications that aren’t right for them. People also tend to assume that a drug is safe if it’s being advertised. Unfortunately, that isn’t always true.
What countries advertise drugs on TV?
Consumer drug advertising is not very common globally. The United States and New Zealand are the only two countries in the world where direct-to-consumer (DTC) advertising of prescription drugs is legal. DTC drug advertising refers to pharmaceutical companies promoting prescription medications directly to the general public.
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Pharmaceutical commercials have been running on TV for decades and drug makers have spent billions of dollars since on ads. Take a look at AbbVie, Amgen, Novo Nordisk, and Pfizer. These companies spent over $3.6 billion on just four drugs from 2015 to 2018.
What are the FDA regulations for drug advertising?
The FDA requires ads to follow certain criteria:
Be truthful
Fairly present both benefits and risks of medications
Share information that is relevant to the product’s advertised uses
Include a brief summary of every risk described in the product’s labeling
According to the FDA’s website, drug ads must state the following:
One or more approved use of the drug
Its generic name
All the risks of taking it, or in some circumstances, listing the most important risks
Can drug commercials leave out information?
If a medication only worked on a few people, would that affect your decision to use it? Maybe. But drug ads don’t have to say how many people the medication has helped. Likewise, ads don’t need to share if other treatments exist or have fewer side effects. They also don’t need to mention if the drug is necessary or if lifestyle changes could be just as effective.
Other important information that drug ads aren’t required to share include:
Drug pricing
Whether insurance plans will cover it
If there is a cheaper generic version
If there are other medications that work just as well
That’s why it can be difficult to make a decision based on drug ads alone.
Not including certain bits of information about a drug isn’t the only way an ad can influence your opinion. The images and language used in drug ads are chosen to create a positive impression. For example, you may notice:
A person enjoying life outdoors while the narrator reads side effects in the background.
The side effects portion being read out very quickly or the most serious side effects of a drug towards the end of the commercial.
Using terms like “mild” which might make people think that the risks aren’t concerning.
Keep in mind that even though risk information is presented in ads, it may not be complete. The FDA allows drug companies to leave out risks in certain ads, as long as they include where to find that information (like on a website or at a healthcare provider’s office).
Does the FDA review drug advertisements before they are released?
Before airing commercials, many manufacturers choose to submit them for FDA clearance to avoid having to withdraw them later. But this is not required. Generally, the FDA does not review drug advertisements before they are released and only regulates ads after they’ve been aired — meaning false drug information could reach you before it reaches the FDA.
Are advertised drugs safe?
In most cases, the FDA does not ban companies from advertising any prescription drugs, even ones that have serious risks. However, some states don’t allow controlled substances (medications that may be habit-forming) to be advertised.
As mentioned, it’s possible for drugs to be promoted before they’ve been fully tested to be safe. This happened with Vioxx (rofecoxib), a popular pain medication marketed from 1994 to 2004. Merck spent over $100 million per year to advertise Vioxx, and people requested it from healthcare providers not knowing it could cause a stroke or heart attack. Finally, in September 2004, after numerous safety issues came to light, Vioxx was taken off the market.
Can you complain about drug commercials to the FDA?
The good news is, if you see any commercial that you think is false, misleading, or biased, you can report the ad to the Office of Prescription Drug Promotion (OPDP) by calling 1-301-796-1200. This is a body within the FDA that reviews drug advertisements.
The bottom line
It’s important to take the information you get from drug commercials with a grain of salt. Crucial information like risks, alternative options, and costs may not be included or shared in full detail. If you have any questions about new medications, talk with your healthcare provider or pharmacist to learn more.
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References
Frosch, D. L., et al. (2010). A decade of controversy: Balancing policy with evidence in the regulation of prescription drug advertising. American Journal of Public Health.
Schneider, M. E. (2021). FDA studies consumer perception of DTC drug ads, willingness to report false claims. Regulatory Affairs Professionals Society.
So, B. K., et al. (2021). Understanding Prescription Drug Advertising. StatPearls.
U.S. Food & Drug Administration. (2015). Prescription drug advertising | Questions and answers.
U.S. Food & Drug Administration. (2022). The office of prescription drug promotion (OPDP).
U.S. House of Representatives. (2021). Drug pricing investigation majority staff report.
Ventola, C. L. (2011). Direct-to-consumer pharmaceutical advertising: Therapeutic or toxic? P & T : a peer-reviewed journal for formulary management.
