Pharmaceutical marketing to consumers and/or caregivers directly, not just to healthcare professionals (HCPs), and/or medical practitioners, is known as direct-to-consumer pharmaceutical marketing.
This aspect is particularly pertinent to pharmaceutical companies that communicate with patients, including viseven, as it could be a direct interaction with the consumers in the United States where the promotion of prescription medicines can be directly directed to consumers.
Patient-focused prescription drug promotions may occur via broadcast media channels, magazine placements, branded websites, digital placements, and search campaigns and social media promotions encouraging consumers to call or visit an HCP to discuss a specific prescription drug.
In the U.S. the promotion of prescription drugs to consumers is well tolerated. This type of promotion is limited or even banned in many countries, particularly by indicating a particular prescription medicine and an approved use. This has resulted in a very mature prescription pharmaceutical marketing industry in the U.S. focused on the consumer.
Prescription drug marketing to consumers is allowed in the United States by the U.S. Food and Drug Administration (FDA), which controls the way the drug benefits and risks are presented.
The emphasis of FDA standards is on the accurate claims, balance benefits/risks presentation and communicating serious risks, especially through broadcast media promotional resources.
Regulatory Background
Prescription drug advertising is regulated by FDA rules and regulations.
Federal regulations empower the FDA to scrutinize promotional claims and take action against advertisements that are deceptive or don’t include pertinent safety details.
Prescription Commercials must be fair and to inform the public of the benefits and risks. Businesses should not say they’re more effective than they are, but they should at least be honest when there are big risks involved, and not claim to have an application they don’t have permission to label.
The fair ad needs to provide balanced information to consumers about what the drug may do and what harms may occur.
Because of this, the tasks assigned to broadcast ads are greater because of the speed and penetration of TV and radio media, and the fact that these media have the ability to reach large numbers of people in a short amount of time. Prescription drug broadcast ads need to include details about the serious harms that could occur and give consumers more details about the label.
Common access methods include:
- A toll-free phone number.
- A website.
- A print advertisement.
- Referral to a healthcare professional.
There are a number of legal sources that regulate direct to consumer pharmaceutical marketing. The primary sources include the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA prescription drug advertising regulations, 21 CFR Part 202 and the FDA Amendments Act of 2007.
The Amendments Act of 2007 by the FDA mandated that the main statement in consumer-oriented broadcast prescription drug advertising be made in a clear, conspicuous and neutral manner.
As with commercial speech, there are also First Amendment concerns in the marketing of prescription drugs. Commercial speech is protected by the Constitution, but false, deceptive or misleading claims can be limited.
The principle of regulation is not to ban the marketing of prescription products, but to stop misleading marketing.
Core Legal Requirements for DTC Prescription Drug Ads
No drug advertising should suggest that a drug is safe, effective, approved or safe for particular groups of patients. Any claims made must be backed by fact and should match that of the drugs official labeling.
Good balance in the presentation is a must. You can’t present an advertisement only about the benefits and at the same time downplay the risks. Risk exposure should be done in a clear manner (not to create an excessively bright view of the medicine to the consumer).
Information that a consumer must have before he or she requests information about a drug is considered “required safety information”. If you have any important disclosures, they are listed here:
- Major side effects
- Warnings
- Precautions
- Contraindications
- Effectiveness information
The contraindications are of importance as they establish situations where a drug is not to be used. For example, a medicine may have an effect when taken with other medicines or a medicine may not be suitable for people with a particular medical condition.
Major Statement is one of the principles in broadcast ads. It’s one of the serious side effects and in violation of the evidence of TV and radio advertising. It’s applied in order to ensure the consumers are given the highest priority risk info during the ad.
In a 2023 final rule the FDA has made a dramatic shift in the “big claims” in statements made in DTC TV and radio ads. There will be no changes to the content. Neutral signs (changed from previous presentation) will be used to clearly and conspicuously present major risk information.
Procedures followed after the time of compliance. FDA’s rule was implemented on May 20, 2024. The compliance requirement was effective from November 20, 2024. Since then, TV and radio ads have been required to present themselves in a new way.
Tensions in the Law/Policy Field
The term “truthfulness” is a simple word that could easily be used to refer to direct-to-consumer pharmaceutical marketing.
Drug promotion materials are not supposed to have any implicit or direct claims that the drug is more effective, safer, approved for more uses, or that the drug is suitable for certain patient populations without proper substantiation and without being consistent with the label.
A balanced presentation is also essential. One simply cannot overemphasize the negative in a promotional piece. Clear communication of risk information is necessary to prevent the consumer from getting a falsely high impression of the drug’s safety.
There are a number of strains in the policy debate:
- There can be some health information available to patients, although there may also be incomplete information.
- Commercial speech rights of companies do not apply to false or misleading claims.
- A broad ban on truthful advertising may be challenges by FDA.
- constitutional limits.
- Physicians’ job is to be gatekeepers and an advertising campaign can shape patient expectations prior to the visit.
First Amendment law is the limit on the extent to which the government can go in its effort to interfere with the truthful promotion of prescription drugs. The over-all ban on business speech would be quite constitutional.
Much more likely is that it will be the regulation that will be targeted for misleading, deceptive or unfair promotions.
This FDA regulatory paradigm is thus disclosure and prevention of misleading.
There are other sources that can be tapped in today’s pharma marketing: Digital agencies, marketing software and technology companies.
The company can control all marketing campaigns regardless of whether they are omnichannel or not, and Viseven can power the pharma and life sciences marketing vertical, plus AI and data services, modular marketing assets, websites, mobile medical apps, portals and healthcare communication tools.
So here are some of the companies that prove that the rules of the game in DTC are applicable to TV and radio advertising, and even more so for the marketing of prescription medicines – and, specifically, digital and integrated marketing.
2023 FDA Final Rule – Clear, Conspicuous, and Neutral
FDA’s 2023 final rule aims to bring clarity to the presentation and verbalization of risk information in DTC media (TV, radio) ads. It mainly serves as a tool to know the consumer better. Simply giving the drug risks to the consumers is not enough, if the disclosure is inaudible, illegible or incomprehensible to them in significant ways.
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Five rules for the major statement were determined by FDA:
- The risk information should be consumer friendly, understandable by the ordinary consumers.
- The sound should be as loud, clear and quick as the rest of the commercial.
- The major statement will be voiced in the TV spots and displayed on screen.
- The computer text is to be bold, properly formatted and the proper size so that it can be easily read.
Avoid technical medical jargon that can impede understanding and use language that a consumer can understand. Any risk that can be described clearly and in simple terms should be included in the ad.
Also, the audio presentation is important. Risk information should never be rushed, reduced in quantity or not communicated as effectively as claims of benefit. The list of side effects, if present, can be effectively outlined, but not spoken fast enough.
Television ads cannot be made without dual presentation. The major risk information should be presented orally to consumers with a display of equivalent information. Text that appears on the screen should be legible, not in fine print, poor contrast, overcrowded or flashing.
Elements that distract can also be considered a violation of the rule. Risk information is not made more difficult to absorb with music, funny pictures, changes of scene, or other unrelated pictures.
New standards are focused on ads that “warn” but don’t make it clear.
Ethical Responsibilities of Physicians
Physicians have an important role to play when patients ask about advertised drugs.
While advertising can initiate a discussion, the decision for a prescription should be made by medical judgment.
Doctors should assess the patient, patient history, current medications and risks, and patient goals before deciding whether an advertised drug is appropriate for the patient.
Neutrality of the professionals must be maintained. A doctor should not prescribe a medicine because a patient requests it and he or she should not refuse to prescribe a medicine because it has been advertised. The response should be based on medical judgment.
A useful patient discussion should address what the patient believes about the drug. Key questions may include:
- What did the patient see or hear in the ad?
- What condition does the patient think the drug treats?
- What benefit does the patient expect?
- What risks does the patient know about?
- What alternatives has the patient considered?
Usage of inappropriate prescribing must be avoided. Physicians should not be pressured by the commercial market and the patient to prescribe drugs that are not clinically indicated. To refuse an unwarranted request helps maintain the safety of patients and the responsibility of practitioners.
It is also required that informed consent be obtained prior to prescribing an advertised product. Patients should be aware of probable benefits, significant risks, reasonable alternatives and why the medication may or may not be appropriate for them.
Corrective information from doctors can remedy the wrong messages in advertising.
Physicians can also file reports of problematic ads. An ad can be a source of concern if it is unclear, inaccurate, misleading, doesn’t target the correct population of patients or promotes self-diagnosis and self-treatment. Reporting helps to aid in safer oversight.
FAQs
Summary
In the United States, prescription drug advertising to consumers is legal, but there are regulations in place to govern it.
Prescribed drug companies can advertise to consumers but with truthful claims, balanced presentation and meaningful risk disclosure.
The current law is not primarily geared towards the prohibition of DTC drug advertising. Instead, it aims to ensure that consumers are provided with accurate, balanced, readable, audible, and not misleading information.
That approach is reinforced by FDA’s clear, conspicuous and neutral requirement for ads on television and radio. Major risk information should not be included as a formality but be presented in a manner consumable by an average consumer.
