Direct-To-Consumer Pharmaceutical Advertising (DTCPA)

Key takeaways

Overview Direct-to-consumer pharmaceutical advertising (DTCPA) refers to marketing and advertising pharmaceutical products directly to the consumers as patients, opposed to specifically targeting healthcare professionals.
This ad provides sources of further information, such as a website and a toll-free telephone number.
and New Zealand as well in other countries and regions where the ban on such advertising is being challenged.

Overview

Direct-to-consumer pharmaceutical advertising (DTCPA) refers to marketing and advertising pharmaceutical products directly to the consumers as patients, opposed to specifically targeting healthcare professionals. DTCPA refers to advertising prescription medicines via mass media communication platforms such as television, radio, magazines, newspapers, and online platforms. Most countries ban any advertising of prescription drugs directly to the consumers.

Direct-to-consumer pharmaceutical advertising is only legal in the US and New Zealand. Still, it is subject to regulations concerning the balanced disclosure of a prescription’s benefits in comparison to its risks, including the side effects and contraindications. Typically, the regulations for DTCPA are applied to advertising materials describing the indications and benefits of the prescription and may be more lenient to advertising materials that don’t discuss its uses.

There are ethical and regulatory concerns surrounding DTCPA, explicitly the extent to which these ads may influence the prescribing of the medicines based on consumer demands when in some cases, they may not be medically required, or other cheaper options are available. Critics of the DTCPA have argued that excess money is spent on marketing the medications instead of research and development in the US. The ad spending by the pharmaceutical industry reached US$5.2 Billion in 2016.

Types of Direct-to-consumer Pharmaceutical Advertising (DTCPA) #

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The Food and Drug Administration (FDA ) defines several common types of DTCPA for prescription medication in the US.

1) Product Claim Advertisement #

This is the most common DTCP advertising that identifies the drug name and trademark brand name of the medication and summarizes the efficacy and risks of the drug.

2) Reminder Advertisement #

Generally, it serves to build brand recognition instead of promoting the drug’s uses and benefits. Though this type of DTCPA ad can provide information about the price or dose, it avoids making claims. Moreover, it cannot contain any information or imagery of the drug itself, including how it functions or the advantages, but may still contain a call to action (CTA) urging viewers to seek an external resource for more information or ask their doctor. The reminder ads may include themes that vaguely allude to the drug’s purpose.

For instance, a reminder commercial for the erectile dysfunction drug Viagra featured the show tune “Good Morning” and scenes of a man walking to work happily, emphasizing a sexual innuendo in the lyric “it’s great to stay up late”.

3) Help-seeking Advertisement #

This is more of an awareness campaign for a specific medical condition instead of marketing the drug name or treatment. So, this type of advertising includes information about a medical condition and encourages individuals to see a doctor or seek an external resource such as a website or a phone hotline for more information. These external outlets may, in turn, be used for promoting specific prescription options. Usually, these types of DTCPA are used as preliminary marketing for new drugs.

The pharmaceuticals often use reminder and help-seeking ads to bypass onerous restrictions such as listing side effects or outright prohibitions on product claims advertising. This is because the types of DTCPA don’t focus on promoting the drug itself. In some cases, a campaign may mix both of these ads with one ad discussing the condition. Another similarly-styled ad mentions the product but not the medical condition, letting the viewers infer the association between the ads.

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Regulation in the US #

Direct-to-consumer advertising of drugs has been legal in the USA since 1985. FDA eased up the rules obliging companies to provide a detailed list of side-effects in their infomercials (long format television commercials) in 1997, and DTCPA really took off.

Under the regulation in the US Food and Drug Administration (FDA) requires all DTCPA information:

To be accurate and not misleading
To make claims only when supported by substantial evidence
To reflect the balance between risks and benefits
To be consistent with the FDA-approved labeling

As per the FDA, the direct-to-consumer “product claim” advertisements for prescription medication must include information about the major side effects and contraindications in the main body, with a “fair balance” of benefits to risks in its coverage. Unless these prescription drugs are given “adequate provision” at a variety of different outlets, the DTCPA ads must include a “brief summary” of all risks related to the medication.

Typically, in print ads within magazines, this summary is given on a second page. The print ads must contain a standard notice that instructs the patients to report negative side effects to the FDA’s MedWatch program.

Whereas, in the ads carried on broadcast media, such as the radio and television commercials, only the major side effects of the drugs are listed, and the ad contains blurbs directing viewers to where they can obtain more information, such as on a website, phone hotline, or a current magazine issue.

If the drug is subjected to a boxed warning from the FDA, it indicates a serious risk. So, the warning must be reproduced in all advertising materials, and reminder ads for the drug are prohibited. Further, the ads that do not make any health claims do not fall under the FDA’s jurisdiction but can still be regulated by the Federal Trade Commission. [3]

What Can You Say? #

The FDA has rules for what drug ads MUST tell the consumers. The FDA criteria include:

At least one approved use for the drug
The generic name of the drug
Not be a false or misleading advertisement
Include the facts about the uses of the advertised product
Present a fair balance of information about the risks and benefits of the drug
A brief summary of the risks of using the drug or the important ones under certain circumstances

This product claim ad identifies the fictional drug’s brand name- Arbitrager and generic name- misvastatium.
It accurately states an FDA-approved use for the drug, in this case, Arbitrager is approved to treat seasonal allergy symptoms.
It says Arbitrager is a prescription drug.
This ad as a whole provides the required “fair balance” of information about the risks and benefits of Arbitrager.
The man on the beach who is pictured in the ad is in the approved age range for users of Arbitrager. So, this ad reinforces that the drug is for adults 18 and older and is not for use in children.
As required by the Food and Drug Amendments Act of 2007, this print ad includes the statement “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.”
This print ad includes a “brief summary” of all the risks listed in the drug’s FDA-approved prescribing information.
This ad directs the reader to seek a doctor’s advice about taking Arbitrager. The pharmaceutical company has included this statement to ensure that a consumer will not think he or she is qualified to make the prescribing decision.
This ad provides sources of further information, such as a website and a toll-free telephone number.

What Can You Not Say? #

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When the industry’s use of direct-to-consumer advertising was challenged in the US in January 2008, it led to an investigation of several advertisements including the one featuring Robert Jarvis rowing a boat for Lipitor by Pfizer. A month later Pfizer pulled that ad and Ian Read, President of worldwide pharmaceutical operations of Pfizer, expressed regret about people getting the wrong impression. Later the pharmaceutical industry announced that it will update its voluntary standards for direct-to-consumer advertising. Moreover, it pledged to stop using actors to play doctors, and to ensure that the endorsers who said they had used a particular drug had actually done so.

The image of the young girl in this fictional drug ad is misleading because Arbitrager is approved for use only in adults 18 years of age and older.
Though the claims must be supported by data from well-designed studies, consumers may not know if such studies exist and show this specific stay. If the FDA determines that claims are not supported, it will take action to have the ad fixed.
This ad falsely states that the fictional drug Arbitrager is approved to help control asthma symptoms while in the correct product claim ad it is approved to treat seasonal nasal allergy symptoms.
This ad shows a specific stay that the consumers may not know about whether such a study exhibited this data. Moreover, if the FDA determines that the ad claims are not supported, it will take action to have the ad fixed.
This ad presents the risks of Arbitrager in small type size and positions this information far from where the benefits are discussed. This makes it harder for the reader to notice and read the risks of this drug. So, this product claim ad doesn’t follow the “Fair balance” needed to specify the risks and benefits of the drug.
This ad does not include the “brief summary,” that includes additional required risk information that should be present in print ads by the Food and Drug Amendments Act of 2007. Usually, a brief summary is given as a statement “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.”

Additionally, pharmaceuticals can choose whether or not to disclose other information such as the drugs price, if insurance plans will cover the cost, the number of people the drug has helped, if the drug is necessary, or if there’s a cheaper generic version or an older medication that works well.

DTCPA and Online Ads #

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Most marketers are beginning to recognize the enormous potential of DTCPA and online ads as it reaches millions of potential consumers globally. Though a vast majority of DTCPA budgets are still allocated to traditional media such as the television, magazine, newspaper, and radio, the marketers are beginning to shift some of their promotional expenditures on digital promotions including product Web sites, search engine marketing, online display advertising, mobile advertising, and social media campaigns.

With the health-related information searches ranked as the third most common activity among the online users in recent years, the drug marketers have also increased their expenditures for marketing efforts on the Internet. The pharmaceutical industry spent $59 million on DTC advertising and promotion on the Internet in the year 2003, and now the spending is estimated to have grown to $1 billion. That’s because the online channel of promotion promises to be lucrative as the data show a 5:1 return on investment for online DTCPA, which is targeted better than print or television ads in reaching the intended audience.

Though the FDA has not yet issued formal guidelines for online DTCPA, it did send warning letters to over a dozen pharmaceutical manufacturers for company-sponsored search engine links that failed to mention the risks of the product. So, now the drug company-sponsored links include the indication or the name of the product and not both. In the absence of regulation for DTCPA and online ads, the drug companies have asked the FDA for guidance regarding what is acceptable especially when advertising on social media platforms.

The internet has become an increasingly popular source of medical information for consumers. As per a 2005 study of over 6,000 adults, though the physician was still the most trusted source of information. Nearly 48.6% of the patients went online before consulting their physician whereas only 10.9% talked to their doctor first.

DTPCA and International Acceptance #

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DTCPA and international acceptance include informing the patients by communicating the safety risks and public health information and warnings about topics such as adverse reactions and online drug purchasing, etc.

This type of advertising informs, educates, and empowers the patients by allowing them to take charge of their health. Consumers can benefit from having access to multiple information sources about drugs and other treatment options instead of solely relying on healthcare providers. It encourages patients to contact their doctors and seek medical advice. As per a 2004 FDA consumer survey, exposure to DTCPA has prompted 27% of Americans to make an appointment with their doctor to talk about a condition that has not been previously discussed.

Another study found that the small print in a drug ad has a strong impact on the patients to contact their physicians. Moreover, the effect of DTCPA increases the patient contact with the doctors through promoting dialogue about the lifestyle changes necessary to improve the patients health. As per the FDA survey, 73% of doctors believed that the DTCPA helped patients to ask more thoughtful questions and 53% of doctors said that it has led to a better discussion with them. So, the DTCPA promotes heightened awareness and detection of any adverse reactions among the patients that lead to a healthy discussion with a physician.

As per studies, DTCPA strengthens the patient-clinician relationship due to the participation of an informed patient in the clinical decision. Because 83% of the ads focus on the physician-patient communication and 76% explicitly promotes consulting your healthcare providers. Additionally, DTCPA reinforces the doctors recommendations and make the patients follow treatment instructions diligently.

In the 2004 FDA study, 33% of physicians reported that DTCPA increased patient adherence. In another study by Harvard University/Massachusetts General Hospital and Harris Interactive, 46% of physicians said that they felt DTCPA increased patient compliance.

DTCPA decreased the under-diagnosis and undertreatment of medical conditions among the patients. As per the 2003 Harvard University/Massachusetts General Hospital/Harris Interactive study, it was found that 25% of patients who visited their doctor after seeing DTCPA received a new diagnosis; of these, 43% were considered to have a high-priority health condition.

However, the physicians thought the DTCPA did not convey information about risks and benefits equally well. About 78% of doctors believe that their patients understand the possible benefits of the drug very well or somewhat, compared to 40% who believe their patients understand the possible risks, while 65% believe these ads confuse patients about the relative risks and benefits of prescription drugs. Moreover, nearly 75% of physicians believed that the DTCPA causes patients to think that the drug works better than it does, and 80% of doctors feel pressure to prescribe the specific brand-name drug when asked.

As per the currently available evidence, the effect of DTCPA on consumers is both positive and negative. An increased understanding of the effects of DTCPA will have significant implications for public health in the U. S. and New Zealand as well in other countries and regions where the ban on such advertising is being challenged. Although a ban on DTCPA has occasionally been called for in the US owing to the debate regarding the rising prices of drugs, it is hoped that the measures to maximize the benefits and reduce the risk of such advertising will allow this controversial, but powerful, medium to be better utilized for the improvement of public health.

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