U.S. FTC announces multi-national working group to build a new approach to biopharmaceutical mergers.

Add greater antitrust scrutiny to the list of headwinds facing the pharmaceutical industry in 2021.

High prices can limit market-access to medicines. This lack of access represents not only a material loss for a drug manufacturer but also poses a risk to patients and nations.

Recognizing that several of the top pharmaceutical and biotechnology acquisitions since 2015 were cross-border deals, the U.S. Federal Trade Commission FTC is joining forces with its international peers (Canada, the U.K. and Europe) in revising and consolidating the approach to examining the impact of industry mergers and acquisitions.

“Given the high volume of pharmaceutical mergers in recent years, amid skyrocketing drug prices and ongoing concerns about anticompetitive conduct in the industry, it is imperative that we rethink our approach toward pharmaceutical merger review”, according to the FTC.

Antitrust reviews generally involve examining product and pipeline overlap but FTC envisions a more comprehensive approach that includes a transaction's effects on prices and access to medicines. Among the questions to be considered, how should nations consider conduct such as price-fixing and reverse payments and what is the full range of a pharmaceutical merger’s effects on innovation?

While the FTC's new stance appears more aggressive, what it actually means in terms of enforcement remains to be seen.