USMCA Working Group Members Introduce Bill to Reduce US Biologics Exclusivity Period
The day after the House working group had its first meeting to hammer out changes to the U.S.-Mexico-Canada Agreement, the renegotiated NAFTA, Rep. Jan Schakowsky, D-Ill., Rep. Rosa DeLauro, D-Conn., a freshman Democrat from a swing district, one Republican and 12 other Democrats introduced a bill that seeks to shorten the biologics exclusivity period in U.S. law to five years. The new NAFTA requires Mexico to raise its exclusivity period from five to 10 years, and Canada to raise its period from eight to 10 years. Current U.S. law is 12 years.
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"Big pharmaceutical companies have been gaming the system for far too long," said freshman Democrat Rep. Angie Craig, of Minnesota, who defeated a Republican incumbent.
Traditional small molecule drugs have a five-year data exclusivity, and these Congress members argue that biologics' higher prices are because of the longer monopoly period more than the cost of developing the treatments.
Craig said, "USMCA contains a provision that ultimately will drive up prescription drug costs in this country, and that is unacceptable. The new NAFTA, as written, would prohibit us from introducing the PRICED Act we are introducing today." PRICED stands for Price Relief, Innovation, and Competition for Essential Drugs Act. Schakowsky also introduced a PRICED Act in 2016 and 2018, but those versions reduced the monopoly period from 12 years to seven years.
Schakowsky, who is one of two members working specifically on biologics in the working group, told a reporter at the June 20 press conference introducing the bill, "Our recommendation is to just take it out." DeLauro is also on the working group, concentrating on enforcement.
Rep. Lloyd Doggett, D-Texas, another PRICED Act co-sponsor, complained that the 10-year exclusivity goes beyond the eight years the U.S. demanded in the Trans-Pacific Partnership. "One of the reasons that agreement failed was because of this very issue," he said, Biologics accounted for 70 percent of drug growth spending, he said.
Freshman Rep. Andy Levin, D-Mich., also spoke at the press conference about why he's a co-sponsor. Levin said two of his children have Crohn's disease and use biologics. He said without insurance, the cost of the Humira one son needed in high school would have been $52,000 a year. Levin said, "We will not vote for [the new NAFTA] unless they get this super protection for biologics out of there."