Bloomberg Government
By Christopher Yasiejko
The Senate Judiciary Committee advanced a slate of bipartisan bills aimed at lowering drug prices by curbing certain patent-related tactics used by pharmaceutical companies to delay cheaper generics and biosimilars.
The legislation considered at Thursday’s markup included measures to block “product hopping,” boost oversight of pharmacy benefit managers, and outlaw tactics that delay generic drug approvals. Proponents say the bills respond to escalating concerns that brand-name drugmakers are exploiting the US patent and regulatory systems to extend market monopolies and raise prices.
The committee, chaired by Sen. Chuck Grassley (R-Iowa), advanced all six of the bills by voice vote. The panel previously approved versions of the bills in February 2023, he said at the proceeding’s outset, but they weren’t considered by the full Senate.
“These bills will help shine a light on prescription drug pricing and clamp down on the abusive practices that continue to unfairly drive up drug costs,” Grassley said in a statement after the markup.
Sen. Dick Durbin (D-Ill.), the committee’s ranking member, said in a statement the measures “will improve coordination between agencies, bring generic drugs to market more quickly, and foster competition in the pharmaceutical industry.” He noted that each bill has bipartisan support and said there’s “real momentum here.”
Senators including John Cornyn (R-Texas) and Richard Blumenthal (D-Conn.) back the Drug Competition Enhancement Act (S. 1040), which would let the US Federal Trade Commission treat product-hopping—in which a drugmaker patents slight changes to a treatment to extend exclusivity and block cheaper alternatives—as anticompetitive conduct.
Sen. Chris Coons (D-Del.) expressed reservation about whether the product-hopping bill “could sweep legitimately innovative products into the category of prohibited switches.” Cornyn promised to address concerns to ensure “that there are no downstream impacts on innovation.”
Speaking in support of the Affordable Prescriptions for Patients Act (S. 1041), which aims to streamline patent litigation over biologic drugs by clarifying how and when infringement claims can be brought, Blumenthal said biosimilars “play a critical role in making drugs more affordable, but pharmaceutical companies abuse and manipulate the patent system to block” more affordable versions of biologic treatments.
“The basic provisions of this bill that protect competition and innovation are essential to making drugs more affordable to the everyday American, who knows, with great anger and frustration, how difficult prescription drugs have become to afford,” Blumenthal said.
Durbin and Sen. Thom Tillis (R-N.C.) co-sponsor the Interagency Patent Coordination and Improvement Act (S. 1097), which seeks to improve collaboration between the US Patent and Trademark Office and the US Food and Drug Administration to review patents listed in the FDA’s registry of approved drugs, the Orange Book. Current law allows a branded-drug maker to automatically delay approval of a proposed copy for 30 months by filing a patent infringement lawsuit.
A task force established by the bill would create “clearer rules to smooth coordination between the USPTO and FDA, and provide greater clarity for all stakeholders,” Durbin said. That “will help the agencies spot and address gamesmanship and allow patent examiners and FDA officials to make well-informed decisions.”
The panel also approved the Klobuchar- and Grassley-backed Preserve Access to Affordable Generics and Biosimilars Act (S. 1096), which would ban “pay-for-delay” settlements—agreements in which brand-name drugmakers pay generics companies to postpone launching lower-cost alternatives.
“Sadly, both companies are enriched” in such arrangements, Klobuchar said. “The brand name company says, ‘Hey, I don’t want to have any competition,’ they give money to the generic, and the only one that gets screwed in the whole thing is the consumer.”
Also approved were the Prescription Pricing for the People Act (S. 527) and Stop STALLING Act (S. 1095).