Further regulation of generic drug competition and drug pricing has been proposed in the latest move by the Federal Trade Commission (FTC). In line with a broader initiative to enforce antitrust laws more numerously, the FTC, on November 7, 2023, announced challenges addressing multiple patent listings by manufacturers of brand-name drugs.
The patents under scrutiny are listed in the Food and Drug Administration’s (FDA) Orange Book, a publication that identifies approved drug products and relevant patent data. According to the FTC’s allegations, over 100 patent listings are implicated, encompassing 62 unique patents and 18 FDA-approved products.
The FTC’s action is a sign of the commission’s more vigorous approach to upholding antitrust laws and making an effort to bring down drug prices, thereby improving affordability of crucial medications. These attempts are largely centered around the promotion of competition within the generic drug market.
Evidence suggests that the competition introduced by generic drugs post patent expiry is a successful strategy to decrease drug prices and that the FTC’s aggressive approach to remove barriers to generic entries can further aid this. However, the FTC’s challenge to such a significant number of listings represents an unprecedented move in its enforcement strategy.
For further details, please refer to the original article provided by Morrison & Foerster LLP.