Promotion does not adequately communicate the diabetes drug’s indication, limits of use and risks, FDA says. It objects to distracting visuals in video and less prominent risk information. Agency had previously relayed its concerns to Lilly about Trulicity promotions.

Generic manufacturers are being cautious on label carve-outs to avoid claims of induced infringement. Bright line rules are necessary, attorney says, and if GSK v. Teva decision is not reversed, legislation will be needed to preserve skinny label. Insurers also face potential liability for placement of skinny-label generics on formularies.

Agencies seek public comment on how they can modernize merger guidelines to enforce antitrust laws. List of questions, including what types of evidence show that a merger could reduce competition, indicate pharma and other mergers will face greater scrutiny.

With the Winter Games approaching, case offers lesson for companies with complex advertising packages. Lilly told the agency two commercials featuring Olympic and Paralympic athletes were intended to run sequentially with another ad including indication and risk information.

Intellectual property became front page news in 2021 as the pandemic ignited a debate on the role of patents in accessing COVID-19 vaccines and therapeutics. 2022 will see a decision on the TRIPS waiver, a new USPTO director, and action on a pending march-in petition.

Big events from the year included the Biden Administration throwing its support behind the TRIPS waiver proposal, companies inking a slew of licensing deals, and the FDA asking the USPTO how it was addressing patent thickets.