THEY SAID IT! LAWMAKERS HIGHLIGHT IMPORTANCE OF GREATER COMPETITION TO LOWER PRESCRIPTION DRUG PRICES AT U.S. SENATE HELP COMMITTEE MARKUP

Lawmakers Advance Bipartisan Solutions to Hold Big Pharma Accountable for Anti-Competitive Practices, Bring More Affordable Alternatives to High-Priced Brand Name Drugs to Market, More Quickly

In case you missed it, the U.S. Senate Committee on Health, Education, Labor & Pensions (HELP) held a markup Wednesday where lawmakers advanced the Biosimilar Red Tape Elimination Act (S. 1954) and the Medication Affordability and Patent Integrity Act (S. 2658).

These bipartisan, market-based solutions would lower drug prices for the American people by fostering greater competition from more affordable alternatives to high-priced brand name drugs. The Biosimilar Red Tape Elimination Act would eliminate outdated U.S. Food and Drug Administration (FDA) requirements and modernize the drug approval process to expedite biosimilar substitution and increase competition from more affordable alternatives to high-priced brand name products. The Medication Affordability and Patent Integrity Act would strengthen coordination between the U.S. Patent and Trademark Office (USPTO) and FDA by requiring more consistent information across agencies, helping improve patent quality, reduce Big Pharma abuse of the patent system and prevent costly delays in the availability of more affordable generics.

Lawmakers from both parties highlighted the importance of these bipartisan solutions to boost competition and lower drug prices. Read more on what they had to say here:

U.S. Senator Bill Cassidy (R-LA), Chairman, Committee on Health, Education, Labor & Pensions: “I thank the sponsors, Senators Lee and Lujan, as well as Senators Paul and Hassan for their work on this legislation to improve access to affordable biosimilar medications. We first began considering this in 2024. I highlighted this bill at a hearing in April. I’m glad to see the progress. Enabling biosimilars to be interchanged with brand name products is common sense that both the Biden and Trump Administrations took steps to advance. Under this bill, FDA will continue to ensure that there are no clinically meaningful differences between biosimilars and brand name products so that patients are protected…  Patents are critical to innovation and driving investments in new therapies for patients, but they are, and should be, time-limited, and abuses can unfairly extend brand monopolies and keep drug prices higher than they should be.”

U.S. Senator Maggie Hassan (D-NH): “For too long, Big Pharma has abused the patent process and blocked generic competition from entering the market, which has meant higher prices at the pharmacy counter for families. One of the ways in which Big Pharma boxes out generic medication is by filing endless patents to block any competition, including by filing brand new patents for original features of their drug that they disclosed to the FDA years beforehand, but withheld from the Patent Office. Prescription drug costs are pushing families and seniors in particular to the brink, and it is time to end this Big Pharma loophole.” 

U.S. Senator Josh Hawley (R-MO): “I just want to add my voice in support of this legislation, and I want to thank Senator Hassan for her leadership on this. Prescription drugs are just too expensive. I mean, that’s the bottom line. They are way too expensive for every family and every individual in this country, and one of the reasons they’re too expensive is that the Big Pharma companies game the system. They tell the FDA one thing, and then they tell the Patent Office something else… It’s a blatant attempt to game the system. Our patent system is a great system. They’re gaming it. And because they’re gaming it, they’re keeping prices high for Americans all across this country. This is a simple bill that would put a stop to that chicanery. We should have done it a long time ago.” 

U.S. Senators Josh Hawley (R-MO) and Maggie Hassan (D-NH), sponsors of the Medication Affordability and Patent Integrity Act, also rebutted proposed amendments and pharmaceutical industry talking points that the legislation would undermine innovation and expose industry trade secrets.

U.S. Senator Josh Hawley (R-MO): “This bill actually expands the protection for trade secrets at the Patent Office, and I just want to note that that’s what the pharma companies asked for last time we introduced this bill. Last time we introduced this bill, they were opposed to it. Of course they’re always opposed to it, but they said, ‘Well, we’d think differently about it if you’d just put some more protections around the Patent Office disclosures.’ So that’s what we did. And now they came back and said, ‘Actually we don’t like those. We want something else.’ And next year it’ll be something else, and then it’ll be something else so long as they keep reaping billions of dollars in profits and nobody can afford their prescription drugs. We’ve got to put an end to this.” 

U.S. Senator Maggie Hassan (D-NH): “Yet again, this is another example of Big Pharma picking away at a bill no matter how hard we try to end a deceptive practice that they’ve been engaged in for years. This [Husted] amendment would make it possible for Big Pharma to endlessly block generic medications from reaching patients. The effect of the Husted amendment would be to effectively remove the defense for generic companies that is provided in the bill, allowing Big Pharma to continue playing unfair patent games in order to block low-cost medications from the market, I think all of us have hospitals and scientists in our states who want to make sure that they are being accurate with their submissions to the FDA and the Patent Office, but it is critical that we pass the underlying bill without this [Husted] amendment in order to help lower drug prices for patients because of course if patients can’t afford the things our brilliant scientists are developing, it makes the work more difficult.” 

Lawmakers also discussed the need to continue working to advance a third solution to, the Ensuring Timely Access to Generics Act, which would improve oversight of the citizen petition process at the FDA, ensuring drugmakers can’t game the system to stall generic competition and patients can benefit from lower-cost alternatives sooner. While this legislation was tabled for a future date, lawmakers offered support.

U.S. Senator Susan Collins (R-ME): “I just want to explain a little bit about how this bill works. It increases competition from generic drugs through better oversight of the FDA citizen petition process. Brand name manufacturers were behind roughly 86 percent of all citizen petitions filed between 2016 and 2019. Overwhelmingly, these petitions did not raise legitimate safety concerns, which is why the FDA rejected more than nine out of 10 of these petitions. Despite the low success rate, petitions are still able to delay generic drug entry and can unfairly consume FDA resources. Our bill, our bipartisan bill, would strengthen the FDA’s ability to reject citizen petitions if it believes that the primary purpose of the petition is to delay approval of the lower priced generic competitor. If enacted, this bipartisan bill would improve competition, save patients money, and also, according to the latest estimate from the CBO, save taxpayers $49 million.”

Watch the full U.S Senate Committee on HELP hearing HERE.

Read more on how Big Pharma games the system to block competition and keep drug prices high HERE.

Read more about how generic and biosimilar competition lower out-of-pocket costs for patients HERE.

Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.