“Direct-to-consumer” medicine ads: Be cautious


If you watch television, flip through magazines or newspapers, surf online, or listen to the radio, you are probably familiar with “direct-to-consumer” advertisements (ads) for prescription medicines. The US and New Zealand are the only two developed countries that allow drug companies to advertise prescription medicines directly to the public. These ads are popular with new medicines that treat chronic conditions such as diabetes and insomnia. In fact, 8 of the top 10 selling medicines in the US currently broadcast or publish at least one “direct-to-consumer” ad portraying happy and satisfied patients. It’s a big business, with drug companies spending an estimated $6.5 billion on “direct-to-consumer” ads in 2016 alone.

FDA oversight of “direct-to-consumer” ads

The US Food and Drug Administration (FDA) oversees the advertising of prescription medicines. The agency ensures that all ads are truthful, balanced, and accurately communicated. However, the FDA does not review and approve all ads before their release. This means that consumers may see ads that are inaccurate or violate FDA regulations before the agency can stop them from appearing or seek corrections. Unfortunately, you may not be able to tell whether an ad includes false or misleading information.

Types of “direct-to-consumer” ads

There are three main types of “direct-to-consumer” ads:

Product claim ads that advertise the medicine’s name and what it treats
Reminder ads that mention the medicine’s name but not what it treats (cannot be used for medicines with serious risks)
Help-seeking ads that describe a disease or condition but do not suggest a specific medicine

Product claim ads must include the medicine’s potential risks and side effects the same way its benefits are presented. All risks must be disclosed in print ads, but only the most important risks must be covered in broadcast ads if viewers and listeners are directed to resources where they can get full information.

Drug companies are not required to tell you:

• The cost of the medicine
• Whether there is a cheaper generic version
• If there is a similar medicine with fewer or different risks to treat the condition
• How the medicine works
• How many people who take the medicine may be helped by it

Supporters of “direct-to-consumer” ads

Those in favor of “direct-to-consumer” ads say it increases consumer awareness and concern about certain diseases and treatments that might result in better health-seeking behaviors. The ads may also encourage consumers to talk with their healthcare providers about their health problems. Advocates say certain ads have helped to remove the stigma associated with diseases like erectile dysfunction and depression, and opened the door to new conversations about undertreated conditions like high blood pressure and high cholesterol.

Critics of “direct-to-consumer” ads

Critics of “direct-to-consumer” ads worry about how these ads might skew a consumer’s view of the medicine’s potential risks and benefits. They are concerned the ads may contain false or misleading information, provide too little information about the medicine’s potential risks and side effects, or make the medicine’s benefits look more attractive than they are. They worry that newly approved medicines that are advertised, often within 1 year of approval, may still have unforeseen risks that were not disclosed because they have yet to be identified. After its initial testing on smaller groups of people to gain approval, new medicines are available to the public at large. So, unexpected side effects are often identified after the medicine has been on the market for a while. (Pending US legislation calls for a 3-year delay on ads for newly approved medicines to allow enough time to catch unexpected side effects.) Critics are also concerned that consumers may pressure their doctors to prescribe an advertised medicine, even if it is not fully needed or a cheaper alternative exists, leading to overuse of costly prescription medicines.

Consumer perceptions about “direct-to-consumer” ads

Consumer perceptions about “direct-to-consumer” ads have become less favorable over time. The percentage of consumers who liked seeing prescription medicine ads fell from 52% in 1999 to 29% in 2004. Also, the percentage of consumers who thought the ads helped them make better decisions about their health dropped from 47% in 1999 to 29% in 2004. According to the more recent 2015 National Consumer Survey on the Medication Experience and Pharmacist Roles, many consumers feel overloaded by the amount of prescription medicine advertising they see on TV. Almost all the comments from more than 300 consumers were negative, suggesting that the ads drive medicine prices up and encourage people to take medicines they don’t need. Most consumers in this survey were against “direct-to-consumer” ads.

Another recent consumer survey conducted in 2017 by Princeton Research Associates looked at the effectiveness of “direct-to-consumer” ads. The survey found that 38% of adults have talked to their doctor about an advertised prescription medicine, and 11% have specifically asked their doctor to prescribe the advertised medicine. However, most did not receive the advertised medicine they had discussed with their doctor. Forty-two percent got the medicine they asked for; 35% got a prescription for a different medicine; and 23% got no prescription at all. Nearly all had discussed an alternative to the advertised medicine with their doctor, mostly generics (50%), a different prescription medicine (40%), or an over-the-counter alternative (32%). The survey findings suggested that ads may be most effective with consumers who are thinking about switching medicines.


“Direct-to-consumer” prescription ads are here to stay and will most likely increase in the coming years. These ads can provide useful information if they are indeed fair, balanced, and honest. However, consumers should be wary of exaggerated claims and place the same amount of scrutiny on ads for medicines as they would on any other advertisements. If you see, hear, or read an ad about a prescription medicine of interest, consider the recommendations in the check it out! column below, to help you work with your healthcare providers in making wise decisions about your health.

check it out!

Consider the following tips when talking with healthcare providers about your treatment options after seeing a “direct-to-consumer” ad for a prescription medicine:

üAsk questions about the medicine. Think about the questions below (Source: FDA) when you see an ad for a prescription medicine, and ask your pharmacist or doctor to help answer them:

• What condition does this medicine treat?
• Why do I think that I might have this condition?
• If I have the condition, am I part of a group the medicine is intended to treat?
• Should I take this medicine if I have a certain condition?
• Should I take this medicine if I am taking certain other medicines?
• Which of the medicine’s possible side effects am I concerned about?
• How will this medicine affect other medicines I am taking?
• Will foods, beverages (alcoholic or non-alcoholic), vitamins, or other supplements affect how this medicine works?
• Are there other medicines that treat my condition?
• Is there a less costly medicine I could use to treat my condition?
• What else can I do to help deal with my condition? For example, should I exercise or change my diet?
• Do other medicines for my condition have different side effects?

ü Learn about the medicine and the condition it treats. Browse the National Institutes of Health (NIH) website for links to information on common diseases, including chronic and infectious diseases. Or, use Drugs@FDA  or DailyMed  to search for specific brand and generic medicines. The FDA requires consumer Medication Guides for certain medicines with known serious side effects. These Medication Guides can be found here. You can also ask your local pharmacist to print a consumer leaflet on the medicine of interest to you.

ü Talk to your pharmacist. “Direct-to-consumer” ads are supposed to provide a fair balance of information relating to the medicine’s risks and benefits. Still, your pharmacist can fill in any gaps, answer your questions, and often provide a realistic picture of the medicine as an option for you. Your pharmacist is in a prime position to educate and guide you to make well informed and safe healthcare decisions, so take advantage of that resource.

ü Talk to your doctor. Ask your doctor whether the medicine might be a good fit for you. Don’t hesitate to discuss your concerns and ask questions about your healthcare, the medicines you currently take, and the medicine you heard about through “direct-to-consumer” ads. Jot down your questions before visiting your doctor using the list above to guide the process.

ü Report violations to FDA. Contact FDA's Office of Prescription Drug Promotion (OPDP) if you think a prescription medicine ad violates the law by being false, misleading, overstating the medicine’s benefits, leaving out or downplaying risk information, or lacking in a fair balance between the risks and benefits. Consumers can call OPDP at 301-796-1200, or submit complaints in writing to:

Food and Drug Administration
Center for Drug Evaluation and Research
Office of Prescription Drug Promotion
5901-B Ammendale Road
Beltsville, MD 20705-1266

Created on December 11, 2017

Medication Safety Alerts

FDA Safety Alerts

Show Your Support!

ISMP needs your help to continue our life saving work