Pharmaceutical Advertising 2024 Global Practice Guide - Food and Drugs Law

Trends and Developments

Pharmaceutical Advertising in the USA: an Introduction

Relevant laws or codes governing pharmaceutical advertising in the USA

In the USA, prescription drug advertising is primarily regulated by the US Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act (FD&C Act) and its implementing regulations, and also through FDA guidance documents (see 21 USC Section 352(n); 21 CFR Section 202.1). Other federal and state government entities that enforce various false and/or deceptive advertising claims (pertaining to prescription drugs) include the US Federal Trade Commission (FTC) and individual state attorneys general. Pharmaceutical company product-related statements have also drawn enforcement scrutiny from the US Securities and Exchange Commission (SEC) where investors have somehow been misled.

Over-the-counter (OTC) and non-prescription drug advertising is primarily regulated by the FTC under 15 USC Sections 52–57, where false or deceptive OTC drug advertising (likely to induce the product's purchase) is unlawful and enforceable by the FTC. The National Advertising Division (NAD) of the Better Business Bureau (BBB – the advertising industry's self-regulatory body) independently reviews and monitors national advertising for accuracy and truthfulness, and offers a voluntary dispute resolution process for advertisers. Many challenges to OTC drug advertising are brought before the NAD for review and adjudication.

Disseminating scientific information on unapproved uses

For many years now, medical product companies have grappled with how to compliantly communicate information concerning unapproved uses of their FDA approved/cleared medical products. In October 2023, the FDA issued its latest guidance on the topic: "Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products". In this guidance, the FDA introduced a new term, "Scientific Information on Unapproved Uses Communications" (SIUU Communications), and defined it as "specific types of communications from firms to healthcare providers (HCPs) of scientific information on unapproved uses of approved/cleared medical products in combination with the disclosures recommended in the guidance". According to the guidance, these communications should be relevant to the "care of an individual patient", and the sources from which they flow should be through published scientific or medical journal articles, clinical references resources or firm-generated presentations of scientific information from an accompanying published reprint.

Prescription drug use-related software

Increasingly, drug sponsors (ie, any company that submits or plans to submit an application to FDA for premarket review) have shown interest in combining the advances of technology with prescription drug delivery or use. However, the use of software in these efforts has raised questions as to how the software's outputs are regulated by the FDA.

In an effort to provide clarity, in 2023 the FDA issued important guidance that describes how it intends to "apply its drug labelling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or prescription drug-led, drug-device combination product" (see FDA Draft Guidance for Industry, "Regulatory Considerations for Prescription Drug Use-Related). The guidance defines prescription drug use-related software as "software that is disseminated by or on behalf of a drug sponsor and produces an end-user output that supplements, explains, or is otherwise textually related to one or more of the sponsor's drug products". As elucidated in the FDA's guidance, prescription drug use-related software may be regulated as a component of a drug's labelling or promotional labelling, as a device, or as a component of a combination product, depending on the drug and on the software's functionality.

Use of quantitative efficacy and safety information in promotion

Although direct-to-consumer prescription drug promotion is legal in the United States, sometimes consumers may not quite understand key efficacy and safety information presented to them in various promotional materials for the promoted prescription drug product. Aware of this, the FDA issued final guidance in 2023 (first drafted in 2018) that provides recommendations for presenting quantitative efficacy and risk information in direct-to-consumer promotional labelling and advertisements for prescription drugs (see FDA Guidance for Industry, "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements"). The FDA's recommendations primarily revolve around improving the language in promotional communications and presenting the efficacy and risk information in a more consumer-friendly manner to foster an easier and more accurate consumer understanding.

According to the FDA, research on the communication of treatment information suggests that consumers can recall and comprehend efficacy and risk information when it is provided quantitatively. In its guidance, the FDA encourages the use of quantitative information from control groups, the use of absolute frequencies or percentages, the use of formatting in a manner that enhances consumer understanding of quantitative risk and efficacy information, and the use of visual aids (eg, graphs, tables, icons) to present quantitative efficacy and risk information.

Clear, conspicuous and neutral major communications

Adding to its efforts to improve consumers' understanding of certain risk information within direct-to-consumer prescription drug advertisements broadcast through television or radio, the FDA finalised its "Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format" rule (originally proposed in 2010) and issued a companion small entity guide on the same topic. Both pertain to the major statement, which describes a prescription drug's most important risks and is required for broadcast advertisements for prescription drugs.

In the preamble to the FDA's final rule, the FDA points out two important findings from a distraction study that was conducted by the Agency and used to support the development of the final rule:

that presenting information through both superimposed text and audio improves consumer understanding; and
that presenting risk information alongside positive imagery does not impede understanding of the information presented.

The FDA completed more studies in 2023 that were incorporated into the preamble to the final rule – the completion of which may have prompted the Agency to finalise the rule. The final rule set forth five standards for compliant major statements:

the major statement must be presented in consumer-friendly language that is readily understandable;
audio information presented for the major statement must be at least as understandable as other audio information in the advertisement;
for television advertisements, the major statement must be presented in audio and text (known as "dual modality"), either with verbatim phrases from the audio or with a transcript, with the text visible for long enough for viewers to understand it;
the major statement text must be placed "appropriately", with contrast, sizing and font choices that allow it to be read easily; and
there cannot be "distracting" audio or visual elements during the presentation of the major statement that are likely to interfere with comprehension.

The small entity guide described scenarios that illustrated each standard and outlined existing practices that the FDA interprets as being compliant with these standards.

Pre-approval product communications

As a general matter, the promotion of a prescription drug prior to FDA approval of that drug is not allowed (see 21 CFR Section 312.7(a)). Over the last several years, the FDA has taken an increased interest in pharmaceutical company prescription drug product communications that cross over into promotional territory (as opposed to pure scientific discourse), issuing enforcement letters to a number of companies. The letters consistently highlight communications that tend to make conclusive statements or representations regarding the safety and efficacy of an investigational new drug (a drug being studied in clinical trials) where the safety and efficacy have not yet been established and the product lacks FDA approval. The FDA's focus on these types of communications has shown no signs of waning.

Product safety and efficacy

The areas of pharmaceutical company advertising that garnered FDA scrutiny in 2023 included communications involving product safety and efficacy. Product safety objections ranged from complete omission of any risk information in a prescription drug advertisement to failure to include the most serious risks associated with the advertised drug product. Product efficacy objections ranged from the overstatement of a drug product's efficacy due to its efficacy profile being misrepresented to the utilisation of data that did not adequately support efficacy claims associated with the advertised product.

It should be noted that claims concerning a prescription drug product's efficacy continue to be a focal point in 2024, as the first letter issued by the Office of Prescription Drug Promotion (OPDP) targeted unsupported quality of life claims. Also noteworthy is the OPDP's increased scrutiny of direct-to-consumer television advertisements, given its issuance of back-to-back enforcement letters for violative television ads where the sole objection was the efficacy presentation of the advertised drug product.

The Federal Trade Commission

The FTC is the primary federal government agency enforcing on unfair and deceptive trade practices, including false advertising. The FTC's primary authority stems from the FTC Act, 15 USC Sections 41–58, under which it has exclusive enforcement authority.

The FTC shares primary responsibility with the FDA in the agencies' concurrent jurisdiction over pharmaceutical advertising, marketing and promotion, according to a memorandum of understanding pursuant to which the FDA regulates all aspects of prescription drugs and the mandated labelling of all other FDA-regulated products, while the FTC has primary responsibility over "the truth or falsity of all advertising (other than labelling) of foods, (non-prescription) drugs, devices and cosmetics". The two agencies advise each other on matters within the other's turf; the FTC defers to the FDA's judgement where the subject matter of OTC drug advertising mirrors FDA-regulated labelling, for example, whereas the FTC has advised the FDA on potential deception in direct-to-consumer advertising of prescription drugs.

The FTC actively enforces on what it deems unfair or deceptive practices in the advertising of OTC drugs, devices and cosmetics, including such things as the efficacy of analgesics. The FTC, sometimes jointly with the FDA, also enforces on disease prevention or treatment claims by foods, dietary supplements and other products that the agencies contend render these products unapproved or misbranded drugs or medical devices.

Use of celebrities

Over the last year, pharmaceutical companies' use of celebrities within prescription drug product advertising and unbranded (no product mentioned) disease state advertisements has risen. However, the use of celebrities within prescription drug product advertisements is not without risks. In the past, the OPDP has issued enforcement letters for celebrity-endorsed prescription drug advertisements where those endorsements did not line up with the advertised product's FDA-approved labelling. Given the expanded reach and following of a celebrity (and the corresponding potential to mislead a large segment of the public), pharmaceutical companies should expect extra attention from the OPDP on the drug advertisements in which they appear.

Competitor activities

Over the last several years, the FDA had taken a pretty inactive stance on competitor superiority claims. Remarks made in 2018 by the FDA's former director of the Center for Drug Evaluation and Research (CDER), Dr Janet Woodcock, at a discussion hosted by the Alliance for a Stronger FDA, signalled that the agency was more inclined to let competitors "duke it out" when it came to disputes not involving threats to human health or safety.

However, enforcement letters issued by the OPDP during 2022 (where the OPDP specifically objected to unsubstantiated product superiority claims) seem to have signalled an end to this look-away era and a resurgence of interest in competitor claims generally. On top of this, when questioned about the OPDP's stance on product superiority claims during the Food and Drug Law Institute's 2022 Advertising and Promotion Conference for Medical Products Conference in Washington, DC (13 October 2022), the head of the OPDP stated that the OPDP is still interested in pursuing unsubstantiated comparative/superiority claims and referenced an enforcement letter as an illustrative example.

Given this shift, pharmaceutical companies wishing to stop competitors from making inaccurate or misleading product comparative claims may want to consider:

submitting competitor complaint letters to the OPDP;
seeking redress under the false/misleading advertising provisions of the Lanham Act; and/or
submitting complaints to the FTC and individual state attorneys general.

Competitors may also lodge a self-regulatory challenge before the NAD, although participation in this forum is voluntary and compliance with the NAD's decision is not legally enforceable.

Since the FTC and state attorneys general are not always responsive to competitor complaints that primarily affect the commercial positions of the parties rather than consumer welfare, the federal Lanham Act litigation may be the only effective option to shut down a competitor's offending marketing claims. However, such litigation has drawbacks, as follows:

the complaining plaintiff carries the burden to prove the falsity of the advertiser's claims, whereas a regulator could require the advertiser to substantiate them;
Lanham Act litigation permits counterclaims against the original plaintiff for any of its own allegedly false advertising that the sued party can dig up; and
like any federal litigation, the process can be lengthy, invasive and expensive.

Consistency with labelling communications

As the FDA has expressed increased interest in real-world evidence (ie, clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data – which is data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources), many pharmaceutical companies have started incorporating, or at least considering how and whether to include, information in advertising and promotional materials that is supported by real-world evidence.

Often, the information supported by the real-world evidence is not included in FDA-approved labelling for the product at issue. As companies continue to navigate this new area of information, the FDA's guidance for the industry, "Medical Product Communications That Are Consistent With the FDA-Required Labelling – Questions and Answers", in combination with lessons learned from various enforcement letters citing the use of real-world evidence, will continue to be of interest to companies. From an enforcement standpoint, several letters issued by the OPDP over the last couple of years focused on the quality and strength of the supportive evidence. Consistent labelling communications will continue to draw scrutiny from the OPDP and will be subject to the FDA if not executed appropriately.

Healthcare fraud and abuse considerations

In recent years, pharmaceutical company speakers' programmes (a practice where pharmaceutical companies pay HCPs, who often prescribe the companies' products, to promote these products to other HCPs) and speaker training meetings have faced intense government scrutiny, where the allegations have been that these events induced HCPs to prescribe prescription drug products in violation of the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). These programmes tend to be the highest-risk marketing practice in the pharmaceutical industry and most likely will retain that designation for some time going forward.

Next on the horizon

The OPDP has publicly announced two direct-to-consumer research studies. One study will examine the use of implied claims in direct-to-consumer prescription drug promotion and the other will examine the use of quantitative claims in direct-to-consumer prescription drug advertising. When complete, these studies should provide the FDA with greater clarity on the use of these types of claims when engaging a consumer audience.

Conclusion

Navigating US rules and policies governing pharmaceutical advertising requires focused attention on several sources of oversight, both official and unofficial – each with unique requirements. Violations of official government-imposed requirements can land companies in significant trouble. However, industry self-regulatory activities are unlikely to yield the same level of enforcement consequences. Nonetheless, one thing is certain: care should be taken to avoid false, misleading and/or deceptive promotional claims and practices, as these tend to be at the heart of many challenges to pharmaceutical product advertising.

Originally published by Chambers and Partners

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

United States: Pharmaceutical Advertising 2024 Global Practice Guide