September 27, 2023

Munger, Tolles & Olson Partner Rohit Singla Discusses the FTC’s Recent Stance on Tackling Drug Pricing

Munger, Tolles & Olson partner Rohit Singla was quoted in Politico’s digital “Prescription Pulse” newsletter in an article titled “Biden Admin Enlists the Orange Book to Tackle Drug Pricing.” The newsletter delivers the latest pharmaceutical news and policy to readers.

The article focused on the Federal Trade Commission’s recent policy statement issued on brand pharmaceutical manufacturers’ improper listing of patents in the Food and Drug Administration’s “Orange Book,” which is the FDA’s catalog of “Approved Drug Products with Therapeutic Equivalence Evaluations.” The FTC’s stance now warns pharmaceutical companies that they could face legal action for improper patents and argues that “improper patent listings may unlawfully delay generic competition for years and disincentivize generic manufacturers from trying to come to market with lower cost alternatives at all.”

Although well-intentioned, Mr. Singla discussed that the FTC’s efforts may backfire. He explained that more generic products may enter the market in the short-term but an unintended consequence could be more litigation in the long term by brand-name companies against generic manufacturers after generic entry. This litigation could lead to major uncertainty and other burdens for generic manufacturers, a resulting drop in generic drug development and testing of patents, and, ultimately, a decline in new generic products in the market.

Read the Politico article.