BY MIKE MAGEE
In President Biden’s State of the Union Address, the most oft repeated phrase was “Let’s Finish The Job!” This came as part of an appeal for partnership as well as an assertion that in his first two years as President much had been accomplished.
Several days later, as if on cue, U.S. Senator Amy Klobuchar (D-MN) and Senator Chuck Grassley (R-IA), joint chairs of the Senate Subcommittee on Competition Policy, Antitrust, and Consumer Rights, announced that two bipartisan pieces of legislation focused on reducing the price of drugs to consumers had passed the Senate Judiciary Committee.
Both bills focus on the range of shenanigans Pharma firms have engaged in to extend their 20 year patents on blockbuster brands and delay generic versions from coming on the market.
The first bill – the Preserving Access to Affordable Generics and Biosimilars Act – is designed to prevent Big Pharma firms from flooding the FDA with sham requests for patent extensions. In the process, opponents have popularized a new term – “patent thicket” to describe the barrage of skimpy patent extension tricks companies use to extend their original 20 years of exclusivity.
How bad can it get? Well in 2022, AbbVie Pharmaceutical successfully fought off accusations that its 132 additional patent requests were not excessive for their blockbuster blood thinner, Humira. Lucky for them, a friendly judge, U.S. Circuit Judge Frank Easterbook agreed, justifying his decision by noting that “Thomas Edison alone held 1,093 U.S. patents.” Funny thing was that the patent for Humira ran out in 2016, but they’re still in control of the money maker now 7 years later. Wow!
The second new bill likely has the longest acronym in legislative history. It’s STALLING for “Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics.” The meat of the proposed legislation would block bribery of Generic Firms on an institutional scale by Big Pharma. These various “pay-to-delay” scams pay off smaller generic firms willing to voluntarily pull or delay their legal filings of generic substitute products for drugs going off-patent.
Sen. Klobuchar has traveled this road before. She was instrumental in loading the Inflation Reduction Act with a provision that allowed Medicare officials to negotiate prescription drug prices. In 2022 she also pressed the Department of Justice and the Federal Trade Commission to investigate Janssen, Bristol-Myers Squibb and Pfizer for collusion on pricing of blood thinner medicines after uncovering lock-step pricing increases of Xarelto and Eliquis.
In the State of the Union, President Biden expressed undying faith in American ingenuity and our willingness, when push comes to shove, to collaborate for the greater good. Turns out both are true. When it comes to greed, there is no end to the ingenious strategies that a bucket full of well paid lobbyists can come up with.
As for collaboration, leave it to Big Pharma to be so consumed by the joys of profit to push the system to the point where politicians from both sides of the aisle are willing to join hands and scream “Enough is enough!”
Mike Magee MD is a Medical Historian and author of CODE BLUE: Inside the Medical Industry Complex.