Senators may be back in their districts gearing up for next month’s elections, but that isn’t stopping them from questioning both the FDA and Federal Trade Commission on matters related to patent and PBM reforms.
In a letter sent Monday to FTC Chair Lina Khan, Senate Finance Chair Ron Wyden (D-OR) and Sen. Sherrod Brown (D-OH) commended the regulator’s recent PBM lawsuit and urged the commission to examine “new PBM tactics that appear to create further barriers to competition and harm the ability of consumers to access lower cost prescription drugs.”
The senators point to how two of the largest PBMs, CVS Caremark and Cigna’s Express Scripts, now have wholly-owned subsidiaries “that purport to co-manufacture certain biosimilars of Humira” but may just be “a veiled attempt by PBMs to control additional parts of the supply chain.”
In the letter, the lawmakers said the substance of those “co-manufacturing” agreements between PBMs and pharmaceutical companies remains unclear.
“Based on available information, a number of the ‘manufacturing’ services provided by PBMs are merely consulting services to the pharmaceutical manufacturers they are partnering with (Sandoz and Boehringer Ingelheim respectively),” they wrote.
Cigna and CVS didn’t immediately respond to requests for comment.
Wyden’s committee in 2023 advanced PBM reforms that would add new PBM oversight and transparency, and in July he renewed his call to pass the legislation.
Orange Book reforms?
Separately, Sen. Bill Cassidy (R-LA), the top Republican on the Senate Health, Education, Labor and Pensions Committee, sent a letter Monday to FDA Commissioner Robert Califf telling him to not let the FTC enforce the terms of when patents should be listed in the FDA’s directory of relevant patents, known as the Orange Book.
The FDA currently plays a ministerial role in reviewing patents and does not vet their relevance. The FTC has made several rounds of requests that companies pull patents that it believes shouldn’t be in the Orange Book.
“Letting FTC enforce terms of the FDCA is an extraordinary abdication of authority by FDA,” Cassidy wrote. “Rather than defer to FTC accusations that drug manufacturers are breaking ambiguous rules, FDA should clarify the rules for brand and generic manufacturers alike.”
Cassidy acknowledges that courts, not the FDA, “referee whether specific patents should be listed in the Orange Book in the context of patent litigation,” but he questions why the FDA has remained silent on listing drug-device combo product patents, as the agency sets the rules for listing patents in the Orange Book.
“Despite nearly two decades of requests from manufacturers for more clarity, FDA has still not told industry how it should list patents for drug-device combinations,” Cassidy writes. “Meanwhile, FTC, with FDA’s apparent encouragement, has filled the vacuum left by FDA.”