FDA Compliance Tips: Avoiding Misleading Drug Advertising
FDA Avoiding Misleading Drug Advertising Team Lead
FDA Avoiding Misleading Drug Advertising Team Lead
Former DOJ Attorney
FDA Avoiding Misleading Drug Advertising Team Lead
Former Senior DOJ Trial Attorney
Misleading Drug Advertising is a Growing Concern for the FDA, and It Puts Drug Companies and Individuals at Risk for Substantial Penalties
Drug companies, telehealth companies, physicians, and others have a legal duty to ensure the accuracy of their advertising materials in order to protect consumers. Advertisements for prescription and over-the-counter drugs are regulated by the U.S. Food and Drug Administration (FDA)—and growing concerns about the volume of misleading drug advertising online have spurred increased oversight and enforcement in recent years.
In early 2024, U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Mike Braun (R-IN) issued a joint letter to the FDA urging it to take more aggressive action to combat misleading drug advertising. In their letter, Senators Durbin and Braun wrote:
“With the dramatic rise in social media use—especially among youth—there has been an alarming proliferation of dangerous and misleading content promoting prescription drugs. We write to urge the Food and Drug Administration (FDA) to take swift action to update its enforcement tools to reflect the current platforms and methods used to promote prescription drugs and biologics, and to prioritize the protection of children from harmful and inaccurate medical advice. . . .
“The power of social media and the deluge of misleading promotions has meant too many young people are receiving medical advice from influencers instead of their health care professional. . . . FDA must exercise authority over this dangerous void to ensure truthful, balanced, and appropriate communications that protect public health.”
The FDA has previously acknowledged the risks associated with misleading drug advertising online; and, in doing so, it has clarified its position that it has the authority to pursue enforcement action against both companies and individuals that unlawfully tout medications on social media and other platforms. With pressure from the Senate, the FDA will likely enhance its focus on misleading drug advertising in the years to come, and this means that drug companies, telehealth companies, physicians, and others will need to ensure that their online advertising campaigns are fully compliant.
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Managing Drug Advertising Compliance to Avoid FDA Scrutiny
Effectively managing a drug advertising compliance program requires an informed and proactive approach. Drug companies, telehealth companies, physicians, and others need to have a clear understanding of what the law allows—and doesn’t allow—and they need to implement appropriate internal and external safeguards to ensure that they do not conduct or facilitate misleading drug advertising campaigns. Here are some key considerations:
The FDA has clear statutory authority to regulate drug advertising under the Food, Drug, and Cosmetic Act (FDCA). The FDCA specifically addresses prescription drug advertising, and it prohibits companies and individuals from publishing advertisements that are inaccurate or misleading.
The definitions of “inaccurate” and “misleading” under the FDCA and the FDA’s regulations are extremely broad. To be considered accurate and non-misleading, claims about a drug must be based on verifiable data collected through scientific analysis or research. Even if a claim might be true, if it is unproven, it is inaccurate and misleading in the eyes of the FDA.
The FDA’s authority to regulate misleading drug advertising extends to all media. This includes (but is not limited to) print, television advertising, and all online platforms. When companies and individuals violate the FDCA—including through direct-to-consumer advertising on social media—they can face fines, injunctions, and other civil or criminal penalties.
Today, much of the concern around misleading drug advertising is focused on social media. This includes not only misleading advertisements from telehealth companies and influencers—as discussed by Senators Durbin and Braun in their letter to the FDA—but also misleading advertisements from drug companies, physicians, and other healthcare providers. Fundamentally, the rules for social media advertising and traditional media advertising are the same: To be legal, drug advertisements must be accurate and non-misleading, and claims related to a drug’s effectiveness and risks must be based on scientifically derived data.
In 2014, the FDA issued draft guidance on social media advertising for the prescription drug industry. This guidance was never finalized; and, as noted by Senators Durbin and Braun, it is outdated in some respects. However, it is not completely outdated; and, at present, it remains the best resource for understanding the FDA’s position on misleading drug advertising on social media.
With this in mind, drug companies, telehealth companies, and other entities seeking to promote drugs on social media should review the FDA’s draft guidance—but they should also take this document for what it is. It is a non-binding statement of policy that is now a decade old. To develop compliant drug advertising programs, companies and others need to consider all relevant sources of legal authority and regulatory guidance, and they need to take a custom-tailored approach focused on their specific risks and needs.
Developing a Drug Advertising Compliance Program
At Oberheiden P.C., our lawyers and consultants help drug companies, telehealth companies, healthcare providers, and others manage all aspects of FDA compliance. This includes developing and managing compliant drug advertising programs. When assisting companies and healthcare providers with drug advertising compliance, we work closely with our clients to help them implement custom-tailored policies and procedures that are designed to help them avoid FDA scrutiny—and withstand FDA scrutiny when necessary.
We help our clients avoid penalties for misleading drug advertising by helping them effectively address key concerns such as:
- Focusing on FDCA Compliance – When preparing to conduct drug advertising campaigns, drug companies and others need to focus on ensuring strict compliance with all pertinent provisions of the Food, Drug, and Cosmetic Act and the FDA’s regulations.
- Ensuring Adequate Substantiation – Substantiation is a critical aspect of drug advertising compliance. If a claim about a drug’s safety or effectiveness cannot be proven, it generally cannot be made.
- Not Overlooking Other Federal Prohibitions and Requirements – While FDA compliance is essential, it is not sufficient. Companies, healthcare providers, and individuals who promote drugs online must comply with the laws and regulations enforced by the U.S. Federal Trade Commission (FTC) and other agencies as well.
- Not Relying on Invalid Disclaimers – While advertisers can use disclaimers in some circumstances, disclaimers will not protect companies or individuals from liability for engaging in otherwise deceptive or misleading drug advertising.
- Drug Advertising Compliance Program Implementation, Monitoring, and Enforcement – Beyond adopting policies and procedures, drug companies and others must implement their drug advertising compliance programs in all relevant areas of their operations, and they must monitor and enforce compliance on an ongoing basis in order to meet their obligations to the FDA.
FAQs: What Drug Companies Need to Know About Misleading Drug Advertising
What is the FDA’s Bad Ad Program?
The FDA’s Bad Ad program encourages healthcare providers to report false and misleading drug advertisements. Healthcare providers have reported thousands of allegedly false and misleading drug advertisements under the Bad Ad program, and the FDA uses the program as a means of identifying potential targets for misleading drug advertising investigations.
When is a Drug Advertisement Considered “Misleading”?
The FDA considers drug advertisements to be misleading in several circumstances. While an advertisement can be considered misleading if it is false, an advertisement can also be considered misleading if it omits material information. If an advertisement makes safety or effectiveness claims without the data needed to support these claims, this will generally be considered misleading drug advertising as well.
This is a complicated question. The short answer is that drug companies can be held responsible for influencers’ social media content in some (but not all) cases. If a drug company hires an influencer or provides products to an influencer in exchange for posting content, then the drug company will generally be responsible. However, if an influencer posts drug-related content independently without a drug company’s involvement, the drug company generally will not be liable—though the company could face scrutiny if the influencer republishes the company’s false or misleading claims.
What Are the Penalties for Misleading Drug Advertising?
The penalties for misleading drug advertising depend on the severity of the violation and the other circumstances involved. In some cases, the FDA may simply issue an untitled letter or warning letter advising the company to come into compliance. In others, it may pursue fines and other civil penalties. In the most egregious cases, the FDA works with the U.S. Department of Justice (DOJ) to pursue criminal enforcement.
How Can Companies Ensure FDA Drug Advertising Compliance?
Ensuring FDA drug advertising compliance requires a proactive approach based on the advice of experienced FDA compliance counsel. At Oberheiden P.C., our lawyers and consultants work with drug companies, telehealth companies, healthcare providers, and other clients nationwide to help them execute compliant drug advertising programs.
Schedule a Complimentary Consultation with an FDA Drug Advertising Compliance Lawyer or Consultant at Oberheiden P.C.
If you would like more information about how we help companies, healthcare providers, and other clients effectively manage FDA drug advertising compliance, we invite you to get in touch. Please call 888-680-1745 or contact us online to schedule a complimentary consultation today.
