Relevant Laws or Codes Governing Pharmaceutical Advertising in the USA

In the US, 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, as well as 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.

Pre-approval Product Communications

As a general matter, 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 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. Although typically issued as Untitled Letters, during 2022 the FDA's Office of Prescription Drug Promotion (OPDP) issued a one-of-a kind Warning Letter for the pre-approval promotion of an investigational drug product being studied for the treatment of COVID-19. 

Product Safety

One area of pharmaceutical company advertising that consistently garners FDA scrutiny is communications involving product safety. Tracing back through decades of enforcement letters from the OPDP and its predecessor, the Division of Drug Marketing, Advertising and Communications (DDMAC), the agency routinely objected to various promotional statements and tactics viewed as minimising or omitting important risk information. Embedded in the OPDP's mission is the aim to protect public health by helping to ensure that prescription drug promotion is truthful, balanced and accurately communicated. Downplaying or completely omitting risk information from product advertising and promotion will continue to capture the OPDP's enforcement interest, as these misrepresentations work to throw off balanced promotional presentations.

Over the years, prescription drug product safety communications have also caught the attention of the US Department of Justice (DOJ), particularly when false statements relating to product safety were made in order to increase the sales of prescription drugs.

The Federal Trade Commission

The Federal Trade Commission (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.

Social Media Marketing and Influencers

Given that we are predominantly living in a digital age, it is no surprise that pharmaceutical company advertising and promotion has increasingly explored digital delivery methods. Through the use of various social media platforms, companies are finding new and innovative ways to deliver tailored messaging to consumers as well as healthcare professionals. Although these platforms may present new ways of delivering content, the rubric of FDA rules and policies governing prescription drug advertising has not really changed that much – as evidenced from OPDP enforcement letters implicating various social media platforms. At the end of the day, prescription drug advertising must be truthful, non-misleading and balanced, no matter the medium.

The FDA has also continued taking interest in influencer advertising – where pharmaceutical companies use various celebrities and/or influencers to market to their large social media following. Influencer marketing for prescription drugs is overseen by the FDA, while that for non-prescription drugs and other products is overseen by the FTC. Sometimes the agencies act jointly, as they did in a late 2021 series of letters to companies and influencers promoting the nicotine-containing liquids used in vaping devices.  These letters and other actions by the FDA and FTC stress the dual requirements associated with influencer marketing:

  • the advertising must be truthful, non-misleading and contain all disclosures that would be required in any other advertising; and
  • any material connection between the influencer and the advertiser must be disclosed, as the FTC considers the failure to disclose such connections to be a distinct deceptive practice.

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, recent 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, the head of the OPDP, during the Food and Drug Law Institute's 2022 Advertising and Promotion Conference for Medical Products Conference in Washington DC (13 October 2022), 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 National Advertising Division (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 advertiser's claims false, 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.

Off-Label Promotion

Although not at a level seen in the early to mid-2000s, the OPDP has not stopped issuing enforcement letters for off-label promotion. The wording and the charges, however, do differ as they are carefully crafted to focus more on misbranding, as opposed to vilifying speech. For example, recent letters cite off-label communications as providing evidence of a new, intended use for which the products' labelling did not provide adequate information for use, rendering the products misbranded. The last couple of letters focused on sales representatives' oral statements and email communications. Given its efforts to continue asserting its presence in this space, continued but measured FDA enforcement against off-label promotion should be expected going forward.

Investor Lawsuits/SEC Scrutiny

Investor lawsuits against pharmaceutical companies for misleading statements made in public-required and investor-related disclosures are becoming more and more commonplace. Often, these statements also appear in company-issued press releases, which have the potential to be viewed as promotional – depending on what is stated and how it is stated. When crafting press releases concerning product performance, potential, or a candidate product's likelihood of FDA filing success, not only should pharmaceutical companies be aware of the various FDA promotional requirements that apply, but they should also think about SEC implications. Many investor lawsuits allege that the company at issue made misleading statements about its product's safety or efficacy that turned out to be not as rosy as depicted, or that somehow actually resulted in a negative FDA action, usually causing injury to investors due to a decrease in stock prices. 

Consistency with Labelling Communications

As the FDA has expressed an 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 in 2022 focused on the quality and strength of the supportive evidence.

Healthcare Fraud and Abuse Considerations

In recent years, pharmaceutical company speakers' programmes (a practice where pharmaceutical companies pay healthcare practitioners (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 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.

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 into 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.