For those who don’t make a practice of reading press releases from the US regulatory bodies, a recent joint statement by the US Food & Drug Administration (FDA) and the US Federal Trade Commission (FTC) may be worth a look. It emphasises the increasing importance of biologics in the pharma sector and the consequent costs implications for healthcare systems. The joint statement is very clear that the US authorities are focussed on fostering competition to biologics from biosimilars mentioning various specific examples of recent US legislative initiatives to encourage or enable greater competition in biologics, largely reflecting the approach to traditional pharmaceuticals. This may be of general interest to those dealing with biologics. What caught my eye, however, was the focus on “false or misleading statements” and the specific comment that “false or misleading comparisons of reference products and biosimilars may constitute unfair or deceptive practices that undermine confidence in biosimilars”.
To some extent this interest reflects the overlapping roles of the FTC and FDA in consumer protection and might be thought not to have particular relevance in the EU (or indeed the UK). However, issues relating to ‘denigration’ of competitor products have been dealt with by competition authorities in Europe under the rules prohibiting abuse of a dominant position – some of these have been discussed by us previously (see here, here and here).
The EU Commission itself drew attention to the competitive dynamics in the biologic/ biosimilar field in its 2019 report on Competition Enforcement in the Pharma Sector. It also mentioned specifically that the dissemination of misleading or disparaging information about potential generic competitors could infringe the competition rules. The Commission referred both to a series of cases taken by the French Competition Authority and to the CJEU judgment in Hoffmann – La Roche (here). And, more subtly, the CMA emphasised in last year’s Remicade decision relating to infliximab and its biosimilars that the commercial context was one in which there was significant clinical caution around the use of biosimilars. The implication was that conditions of nascent competition were delicate, and could be easily harmed by conduct which dented doctors’ confidence to prescribe the biosimilar products. (Despite this, the CMA ultimately found no grounds for action against Merck in this case.)
Against that background, the FDA/FTC joint statement emphasises, if emphasis were needed, that the pharma sector in general (and increasingly competition between biologics and biosimilars) continue to be carefully scrutinised. As is clear from the recent Paroxetine Judgment of the CJEU as well as the other rulings referred to above it is more important than ever for those involved in the manufacture and supply of medicines to be aware of the competition authorities’ focus on conduct that is not “competition on the merits”. That concept has shown itself to be elastic and its precise boundaries continue to be explored, but in both the US and in the EU making disparaging or misleading comments about competing products with a view to reducing competition may well be beyond the boundary.
The FDA/FTC joint statement finishes with a brief (but important) statement: “FDA and FTC will collaborate on efforts to ensure biosimilar development and uptake are not hindered by other anticompetitive practices”. This echoes the final sentence of the Commission’s 2019 report: “Ensuring that effective competition law enforcement helps patients and healthcare systems to access affordable and innovative medicines is a priority for the Commission”.
On this issue at least there appears to be a degree of transatlantic harmony.