Antitrust Law Daily Wrap Up, ANTITRUST NEWS: FTC staff comments on FDA naming proposal for biologic products, (Oct 28, 2015)

By Linda O’Brien, J.D., LL.M.

In response to a request form the Food and Drug Administration (FDA), the staff of the FTC’s Office of Policy Planning, Bureau of Economics, and Bureau of Competition provided comments today on the on the FDA’s draft guidance addressing nonproprietary names for biological products. The nonproprietary name of a pharmaceutical identifies its active ingredient and appears on each drug’s FDA-approved label and in databases used by both physicians and pharmacists.

In its draft guidance, “Nonproprietary Naming of Biological Products: Guidance for Industry,” the FDA proposes adding a new, random suffix to the nonproprietary name of each biological product. The purpose of the FDA’s naming convention is to improve pharmacovigilance and minimize possible inadvertent substitution of biological products that the FDA has not determined to be interchangeable.

Building on the FTC’s extensive experience in evaluating healthcare competition and studying competitive issues affecting biologics, the staff comment suggests that the FDA’s naming convention, which departs from the FDA tradition, may cause physicians to believe mistakenly that the products necessarily have clinically meaningful differences. A misperception that the active ingredient in a biosimilar differs in clinically meaningful ways from that in the reference biologic could deter physicians from prescribing biosimilars, thus impeding the development of biosimilar markets and potentially resulting in reduced price competition in biologic drug markets, according to the FTC staff.

Biosimilar competition is important because biologics are among the most promising medicines for the treatment of a variety of medical conditions for which patients have no other alternative, the comment notes. The relatively high prices of biologics, combined with patient cost-sharing requirements, can limit patient access to biologics. Price competition from biosimilars would likely lead to reduced prices for, and greater patient access to, biologics and biosimilars, the comment observes.

Additionally, the FDA’s naming proposal is not consistent with a proposal for biologic naming currently under consideration by the World Health Organization and, according to the staff comment, can create unnecessary costs, and conflicts with efforts toward global naming harmonization.

The comment asks the FDA to reconsider its proposal and sets forth alternatives with less impact on competition that could achieve FDA’s purpose to avoid inadvertent substitution and improve the reporting of adverse events involving biologics to the FDA. First, reliance on trade names may improve pharmacovigilance and prevent inadvertent substitution. Second, the FDA-published Purple Book—which is comparable to the FDA-published Orange Book, but lists biological products—can prevent inadvertent substitution by pharmacists.

In conclusion, the staff notes that it is unclear to what extent physician misperception resulting from FDA’s proposal might threaten the full potential benefits that healthcare consumers could recognize from biosimilar competition. However, given the availability of alternative approaches that appear likely to achieve the FDA’s objectives for this naming convention without introducing the potential harm to competition, the FDA should reconsider its approach, the staff advised.

News: Antitrust ConsumerProtection FederalTradeCommissionNews