How to Stay Out of Trouble When Advertising in the Healthcare Industry
What to avoid and what to follow when advertising in the healthcare industry.
Are you a healthcare advertiser who wants to promote your products or services in a way that is legal, ethical, and effective? To do so, you need to be aware of the various laws and regulations that apply to your field, and how to avoid the common mistakes that could land you in trouble. Healthcare advertising is not only a complex and highly regulated field, but also a dynamic and competitive one, where you need to stand out from the crowd and deliver value to your consumers.
In this post, we will show you some of the major legal pitfalls that you should steer clear of when creating your healthcare advertisements, and give you some tips on how to craft compelling and compliant messages that will boost your business and benefit your consumers.
The FDCA and FDA Regulations
The Federal Food, Drug, and Cosmetic Act (FDCA) and U.S. Food and Drug Administration (FDA) regulations and guidance apply to the advertising of prescription drugs, medical devices, biologics, and other products regulated by the FDA. The FDCA and FDA regulations require that healthcare advertisements be truthful, accurate, balanced, and not misleading, and that they include adequate information about the benefits, risks, indications, and limitations of the products. The FDA also issues various guidance documents on specific topics related to healthcare advertising, such as direct-to-consumer promotion, social media, risk communication, and comparative claims.
Avoid the following when advertising FDA-regulated products:
Making false or unsubstantiated claims about the safety, effectiveness, or superiority of the products
Omitting or minimizing important risk information or contraindications
Exaggerating or overstating the benefits or indications of the products
Using ambiguous or vague terms that may confuse or mislead consumers
Making comparative claims without adequate scientific evidence or fair balance
Using endorsements or testimonials that are not representative of typical results or that imply personal recommendations by healthcare professionals
Failing to disclose material information or conflicts of interest
Promoting off-label uses or unapproved products
Follow these best practices instead:
Review the FDA regulations and guidance documents relevant to their products and advertising methods
Consult with legal counsel or regulatory experts before launching any new campaigns or materials
Ensure that all claims are supported by valid scientific data and consistent with the approved labeling of the products
Provide clear and prominent disclosure of all material information, including risk information, indications, limitations, and conflicts of interest
Use simple and understandable language that is appropriate for the intended audience
Seek pre-clearance or feedback from the FDA if in doubt about the compliance of their advertisements
The FTCA and FTC Regulations
The Federal Trade Commission Act (FTCA) and U.S. Federal Trade Commission (FTC) regulations and guidance apply to the advertising of over-the-counter drugs, dietary supplements, cosmetics, and other products not regulated by the FDA. The FTCA and FTC regulations require that healthcare advertisements be truthful, substantiated by competent and reliable scientific evidence, and not deceptive or unfair. The FTC also issues various guidance documents on specific topics related to healthcare advertising, such as health claims, endorsements, testimonials, and native advertising.
Avoid the following when advertising FTC-regulated products:
Making false or misleading claims about the nature, quality, or performance of the products
Making health claims that are not supported by adequate scientific evidence or that go beyond the evidence
Making claims that imply FDA approval or endorsement when none exists
Using deceptive formats or techniques that disguise the commercial nature of the advertisements
Using endorsements or testimonials that are not truthful or substantiated by actual experience or expertise
Failing to disclose material connections or compensation between the advertisers and the endorsers
Follow these best practices instead:
Review the FTC regulations and guidance documents relevant to their products and advertising methods
Consult with legal counsel or regulatory experts before launching any new campaigns or materials
Ensure that all claims are truthful and backed by competent and reliable scientific evidence that meets the FTC’s standards
Provide clear and conspicuous disclosure of all material information, including health claims, endorsements, testimonials, and native advertising
Monitor and correct any false or misleading statements made by third parties about their products
The HIPAA Privacy Rule
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule applies to the protection of personal health information (PHI) collected or used by healthcare providers, health plans, or healthcare clearinghouses. The HIPAA Privacy Rule requires that healthcare advertisers obtain valid authorization from individuals before using or disclosing their PHI for marketing purposes, unless an exception applies. The rule also gives individuals the right to opt out of receiving marketing communications from healthcare entities.
Avoid the following when using or disclosing PHI for marketing purposes:
Using or disclosing PHI without obtaining valid authorization from the individuals
Using or disclosing PHI for purposes that are not consistent with the authorization
Failing to provide individuals with a clear and easy way to opt out of receiving marketing communications
Failing to honor the individuals’ opt-out requests
Failing to safeguard the confidentiality and security of the PHI
Follow these best practices instead:
Review the HIPAA Privacy Rule and guidance documents relevant to their use or disclosure of PHI
Consult with legal counsel or privacy experts before using or disclosing any PHI for marketing purposes
Obtain valid authorization from the individuals before using or disclosing their PHI for marketing purposes, unless an exception applies
Provide individuals with a clear and easy way to opt out of receiving marketing communications, and honor their opt-out requests
Implement appropriate administrative, technical, and physical safeguards to protect the confidentiality and security of the PHI
The Truth in Healthcare Marketing Act
The Truth in Healthcare Marketing Act of 2017 applies to the prevention of deceptive and misleading marketing practices by any business in the healthcare industry. The act covers all communications between patients and healthcare providers, including doctors, nurses, physicians, physician assistants, and other care providers. The act prohibits healthcare advertisers from making false or misleading statements about their credentials, qualifications, affiliations, services, or products. The act also requires healthcare advertisers to disclose any financial or other conflicts of interest that may affect their recommendations or referrals.
Avoid the following when marketing credentials, qualifications, affiliations, services, or products:
Making false or misleading statements about their education, training, certification, licensure, accreditation, or experience
Using deceptive or confusing titles, designations, abbreviations, or symbols that imply a level of expertise or authority that they do not have
Claiming affiliation with an organization or institution that they are not affiliated with
Offering services or products that they are not qualified or authorized to provide
Failing to disclose any financial or other conflicts of interest that may influence their recommendations or referrals
Follow these best practices instead:
Review the Truth in Healthcare Marketing Act and guidance documents relevant to their marketing practices
Consult with legal counsel or ethical experts before making any statements or representations about their credentials, qualifications, affiliations, services, or products
Ensure that all statements or representations are truthful and accurate and reflect their current status and capabilities
Use clear and unambiguous language that does not mislead or confuse consumers
Disclose any financial or other conflicts of interest that may affect their recommendations or referrals
Conclusion
Healthcare advertising requires careful attention to the laws and regulations that govern it. Healthcare advertisers must comply with various federal and state laws that aim to protect consumers from false, misleading, or deceptive claims, and to safeguard their privacy and personal health information.
By following the best practices discussed in this article, your team can avoid some of the major legal pitfalls that may arise in their advertising campaigns, and create effective and compliant advertisements that benefit both your businesses and consumers.
Florence Rose Group is a team of experts in healthcare marketing and communication. Working with us, we help you skip the lengthy step of consulting legal experts and regulators, and ensure your team is properly informed for any upcoming advertising campaigns. We can help you craft compelling marketing strategies that resonate with your target audience and comply with the relevant laws and rules.
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