What should I watch for next with Pfizer?
Four pressure points: patent settlement scrutiny, promotional enforcement, PBM reform, and whether Congress revisits the orphan-drug Medicare exemption.
Four areas. First, whether federal antitrust authorities examine the tafamidis patent settlements that push generic entry to 2031, given long-standing regulatory hostility to pay-for-delay deals. Second, promotional disputes in ATTR-CM - including the matter the National Advertising Division referred to federal agencies - against the backdrop of a wider federal crackdown on drug advertising.
Third, whether PBM reforms, such as the FTC's insulin settlements that require PBMs to delink their fees from list prices, change how high-priced incumbents are positioned on formularies. Fourth, whether Congress revisits the orphan-drug exemption from Medicare negotiation. Researchers projected that tafamidis would earn about $23.7 billion from launch through 2029 - the earliest year it could be negotiated if the exemption were removed. With tafamidis now about 10% of Pfizer's revenue, any change to its pricing or exclusivity will be material for the company.