By B. Brett Heavner and Kathryn R. Judson
Over the last few years, stakeholders in the biosimilar field have urged the FDA to address common questions related to promotional labeling and advertisements for biosimilar and reference products. On Feb. 3, 2020, the FDA published Guidance for Industry on Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products addressing these common questions and provided recommendations for how to best develop and present promotional materials for biosimilars.
This article will outline the central components of this new guidance as it relates to biologics labeling and promotional documents. While such materials are overseen by the FDA and governed by the laws within the Food, Drug and Cosmetic Act (FDCA), we also explore an alternative method of challenging claims of misinformation and other forms of unfair competition that may impact the biosimilar space moving forward.
The FDA’s General Requirements For Promotional Materials
Advertising and promotional labeling for prescription drugs (including reference products and biosimilar products) is subject to the FDCA and FDA regulations. These regulations require that “promotional labeling and advertising must be truthful and non-misleading, convey information about a drug’s efficacy and its risks in a balanced manner, and reveal material facts about the drug.”
According to the guidance, to determine whether a promotional presentation is truthful and non-misleading, a fact-specific inquiry should consider:
- “how the information is presented;
- the type and quality of the data relied on to support the presentation; and
- contextual and disclosure considerations.”
Additionally, pharmaceutical manufacturers must promptly update promotional labeling and advertising for their biological products when there is “a proposed change in the package insert, package label, container label, or . . . Medication Guide” based on new safety information or information related to reduced effectiveness.
Promotional Materials And Labels For Reference And Biosimilar Products
The guidance requires that manufacturers carefully evaluate promotional materials for reference products or biosimilar products to ensure that the information within the materials correctly identifies the product(s) to which the information applies (e.g., the reference product, the biosimilar product, or both).
Pharmaceutical manufacturers “should also ensure that if promotional materials describe studies in which non-U.S.-licensed comparator biological products were used (or if promotional materials otherwise mention such products), the promotional materials accurately identify the non-U.S.-licensed comparator biological products.”
The guidance recommends that pharmaceutical manufacturers refer to a biosimilar’s FDA-approved labeling when developing promotional materials because the biosimilar’s label will incorporate relevant data from the reference product’s label. A biosimilar product’s FDA-approved label is important — it contains information from the reference product’s label regarding conditions of use, clinical pharmacology studies, immunogenicity, and toxicity.
If promotional materials present information not previously included in the biosimilar product’s label (i.e., information from studies conducted to demonstrate biosimilarity), the advertiser must ensure that those promotional materials are “consistent with the biosimilar’s FDA-approved labeling and be truthful and non-misleading.”
Whether a promotional presentation is truthful and non-misleading involves a fact-specific determination as outlined above; however, representations that suggest clinically meaningful differences between the reference product and its biosimilar are likely to be false or misleading. The guidance suggests that “meaningful differences” include, but are not limited to, differences regarding safety, purity, and potency. In addition, the guidance gives many examples of when a promotional presentation may be misleading, including when a promotional presentation creates an impression that a reference product is safer, more effective, or superior to its biosimilar product.
Misleading Advertisement And Promotional Labeling For Biosimilar Products Under The FDCA And Lanham Act
In the United States, prescription drug advertising is primarily governed by the FDCA and FDA regulations. The FDCA requires all pharmaceutical advertisements and other descriptive printed material to present specific information about the drug product (e.g., established name, quantitative formula, side effects, contraindications, and effectiveness) in a “clear, conspicuous, and neutral manner.”The FDCA and FDA regulations focus primarily on consumer safety, but there is another enforcement option that allows a private right of action for false or misleading pharmaceutical commercial advertisements — the Lanham Act.
While the Lanham Act is best known as the federal law governing trademarks, section 43(a) creates a broad federal remedy against unfair competition.Section 43(a) is a statutory remedy giving a private right of action for false or misleading commercial advertising that “misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person’s goods, services or commercial activities.”
Even though U. S. courts strive to give legal effect to both the FDCA and the Lanham Act, pharmaceutical manufacturers should be aware that the two laws are separately enforceable.The U.S. Supreme Court held in POM Wonderful LLC v. Coca-Cola Co. that a claim for false or misleading advertising under section 43(a) of the Lanham Act was not preempted by the FDCA.The court noted that the FDCA’s and Lanham Act’s false advertising provisions “complement each other . . . for each has its own scope and purpose.”Prior to the decision in POM Wonderful, there were several cases where lower federal courts rejected claims of preemption.For example, in Schwarz Pharma, Inc. v. Breckenridge Pharmaceutical, Inc., the district court held that the defendant’s claim that its product was bioequivalent to the plaintiff’s prescription drug was actionable under section 43(a) and not preempted under the FDCA.Similarly, in Mylan Labs., Inc. v. Matkari, the Fourth Circuit reversed the district court’s decision to dismiss the plaintiff’s section 43(a) claim that the defendant had falsely alleged that its drug was bioequivalent to the plaintiff’s.
Although the FDA’s guidance requires manufacturers of reference and biosimilar products to avoid false and/or misleading promotional materials, its enforcement mechanisms are administrative in nature.The guidance invites manufacturers to voluntarily seek FDA feedback on promotional materials before dissemination, and manufacturers are subject to post-marketing reporting requirements. Despite the fact that the FDA may impose civil penalties for specific violations of the FDCA, including violations relating to improper dissemination of advertisements for approved drugs or biologic products, the FDA does not “preapprove” biosimilar product labeling and advertisements prior to dissemination.If the FDA determines that an advertisement is false or misleading, it will send the company a warning letter identifying the violation and providing the company with directions for correcting the problem.
In contrast, the Lanham Act provides an alternative litigation route for addressing false advertising of biosimilar products even when the FDA does not raise an objection to a given advertisement. In Novartis Consumer Health, Inc. v. Johnson & Johnson-Merck Consumer Pharms. Co., Novartis successfully sued Johnson & Johnson (J&J) for false advertising in violation of section 43(a) of the Lanham Act despite the fact that the FDA never took any action in response to J&J’s advertising campaign for its MYLANTA Night Time Strength (MNTS) product. Novartis alleged that J&J’s advertising for its over-the-counter heartburn medication, MYLANTA, was false and misleading because the advertisements suggested that MNTS was “specifically formulated for night time heartburn . . . and/or possessed a strength that correlate[d] with its efficacy. The court enjoined J&J’s use of the MNTS name because it was literally false, “convey[ing] the unambiguous message that the product is specifically formulated to relieve nighttime heartburn.” In addition, the court held that the MNTS name would imply a “false message . . . or alternatively that the MNTS name and label [would] mislead a substantial portion of consumers.”
Pharmaceutical manufacturers need to be aware of both the FDCA regulations and the Lanham Act’s false advertising provisions when preparing prescription drug promotional advertisements and labeling. The promotional information must be truthful and non-misleading, convey information about a drug’s efficacy and its risks in a balanced manner, and reveal material facts about the drug to satisfy the FDA’s requirements. By publishing truthful and accurate information concerning reference and biosimilar products, not only will the FDA continue to improve patient access to biologics, but doing so will also increase physician familiarity with biosimilar products. In addition, the interplay between enforcement under the FDCA and the Lanham Act will help combat prevalent anticompetitive behavior and deceptive or unfair business practices within the biologics market.
About The Authors:
Brett Heavner is a partner at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. His practice includes all aspects of trademark and unfair competition law, with a particular emphasis on trademark infringement, counterfeiting, false advertising litigation, and Trademark Trial and Appeal Board (TTAB) litigation. He works with companies in the life sciences, pharmaceuticals, consumer products, and energy industries.
Kathryn Judson is a law clerk at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. She focuses on pharmaceutical patent litigation, specifically Abbreviated New Drug Application (ANDA) cases; patent prosecution; and proceedings before the U.S. Patent and Trademark Office (USPTO). She has technical experience in the biological, chemical, and pharmaceutical fields.
 Promotional labeling refers to any labeling other than FDA-required labeling meant for promotion of the product which includes printed, audio, or visual matter.
 “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers,” Guidance for Industry (February 2020) (“Guidance”), available at https://www.fda.gov/media/134862/download.
 Guidance, supra note 2, at 3:77–78; See 21 U.S.C. §§ 321(n), 352(a) and (n); 21 C.F.R. §§ 1.21(a), 202.1(e)(5).
 Id. at 3:81–84; See 21 C.F.R. § 601.12(a)(4); see also 21 U.S.C. § 355(o)(4).
 Id. at 5:143–49; See “Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers,” Guidance for Industry (June 2018), available at https://www.fda.gov/media/133619/download.
 Guidance, supra note 2, at 6:167–72.
 15 U.S.C. § 1125(a)(1)(B).
 POM Wonderful LLC. v. Coca-Cola Co., 573 U.S. 102, 115 (2014).
 Schwarz Pharma, Inc. v. Breckenridge Pharma., Inc., 388 F. Supp. 2d 967, 973–75 (E.D. Wis. 2005).
 Mylan Labs., Inc. v. Matkari, 7 F.3d 1130, 1137–138 (4th Cir. 1993).
 See 21 CFR 601.12(f)(4).
 See 21 U.S.C. § 333(g).
 U.S. Food & Drug Administration, “About Warning and Close-Out Letters,” available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/about-warning-and-close-out-letters.
 Novartis Consumer Health, Inc. v. Johnson & Johnson-Merck Consumer Pharms. Co., 290 F.3d 578 (3d. Cir. 2002).