Several weeks ago, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced plans to collaborate to manage and restrict misleading information on biosimilars being disseminated by reference manufacturers. This messaging, designed solely to place doubt into the mind of patients, providers, and payers, is considered to be a significant obstacle to biosimilar adoption. In order to advance its initiatives, the FDA and FTC organized a public “workshop” on March 9.
Tara Isa Koslov, Esq., Chief of Staff, of the FTC read the prepared remarks by Chairman Joseph Simons, which pointed to the regulator’s extensive experience in bringing actions against branded drug manufacturers engaging in anticompetitive activities against generic manufacturers. “Competition between reference biologics and biosimilars is just as important as competition between brand and generic small-molecule drugs,” he said. Mr. Simons noted that “competition only works when consumers have reliable and truthful information.”
There is little doubt that enforcement will be needed, based on past experience. Reference manufacturers have tried to malign biosimilar agents either through outright false statements (e.g., “biosimilars do not provide the same effectiveness/safety of a reference biologic”) or misleading messages (e.g., since biosimilars are not exact copies, they are somehow of lower quality relative to the branded reference drug). Most of the enforcement powers of the FDA and FTC in this realm come from their ability to issue warning letters, according to Dominic Cirincione, Regulatory Council, Office of Prescription Drug Promotion at the FDA.
Ms. Koslov indicated that misleading information would violate the law by (1) violating consumer protection laws by falsely advertising the impression that there are “clinically meaningful differences between a reference biologic and its biosimilar” and (2) creating an antitrust situation whereby misleading or false information forms “artificial barriers to entry and creates costs for biosimilar manufacturers.”
Lowell Schiller, Principal Associate Commissioner for Policy at the FDA, asserted that there is a natural incentive for reference drug makers to discourage competition, “but it undermines our system.” Those efforts usually take the form of trying to position competitive products as somehow inferior, which is not the case for biosimilars.
A product designated as interchangeable, on the other hand, could present a more challenging situation: How can a reference product maker argue that an interchangeable biologic is inferior to its originator drug (although the same should be said with any biosimilar)? Mr. Cirincione noted that the FDA had not yet written any policies for misleading information regarding interchangeable products. It matters little, because the FDA has not provided that designation to any manufacturer’s biologic. An interchangeable designation would not be relevant for a drug covered under the medical benefit, which is the case with all biosimilars launched to date. The reason is that it would not be substitutable at the retail pharmacy.
Hillel Cohen, PhD, Executive Director, Scientific Affairs, Sandoz, emphasized that misleading information is not limited to statements that are not factual. Speaking as co-chair of the Education Committee of the Biosimilars Forum, Dr. Cohen pointed to “negative framing of factual statements,” where inferiority can easily be inferred, is a real problem. An example is, “biosimilars are only similar or highly similar, but are not identical.” He continued, “We’ve seen negative comments about efficacy, safety, quality, and the regulatory pathway. We’ve also heard that we still don’t have enough data on switching, implying that we don’t know it’s safe.” Michael A. Carrier, Distinguished Professor, Rutgers Law School, added, “You can have deceptive, misleading statements even if they are not completely false.”
Dr. Cohen and the Biosimilars Forum believe that all messaging “should be based on the FDA documents (though not all are easy for patients to understand) and tailored to their audiences. The Biosimilar Forum is willing to work with stakeholders to make this happen.” He concluded, “The FDA and FTC should exercise their authority when possible to ensure this happens.”
The real question may not be what constitutes misleading information or false characterizations that might set off alarms at the FDA and FTC, but what enforcement teeth the agencies use to discourage and prevent such activities.