Sen. Marshall Amendment Protects Access to Breakthrough Treatments and Life-Saving Medicine

(Washington, D.C., August 6, 2022) – U.S. Senator Roger Marshall, M.D. will offer an amendment to the Democrats’ reckless, more than $700 billion reconciliation package in an effort to protect Americans’ current and future access to breakthrough treatments and life-saving medicine by excluding them from federal government-controlled drug pricing. Without Senator Marshall’s amendment, the Democrat-led bill will leave the U.S. with at least 15% fewer drugs developed and brought to market in the next 17 years. Additionally, it would threaten access to next-generation treatment and care for patients with life-threatening illnesses. And, frustratingly, this bill takes any potential Medicare savings and uses them to supplement wealthy individuals’ ACA subsidy, rather than pouring it back into Medicare to help it remain solvent. The amendment follows an op-ed he penned for FOX News today detailing how price controls harm pharmaceutical innovation and access. 

“Rather than a healthcare system that offers Americans breakthrough medicines, this reckless tax and spend bill will force Americans to settle for end-of-life care. That’s wrong. As a physician who practiced medicine for more than 25 years, I will not let that happen without a fight,” said Senator Marshall. “Having the best tools and medicine to treat patients helps physicians achieve our mission of keeping patients happy, healthy, and at home with their loved ones. When Congress created the Medicare Part D program, there was wisdom in this body that certain patient populations should be protected. And with continued congressional support, this policy has remained. We know government price controls on life-saving medicine will kill innovation. My colleagues across the aisle need to recognize the basic economics that allows the U.S. pharmaceutical industry to be the best in the world. If Congress eliminates incentives for an industry with a 95-100 percent fail rate in cancer drugs, we’ll never get a cure. Americans deserve better. I urge my colleagues to abandon this poorly constructed scheme and tackle drug pricing with bipartisan, long-lasting solutions.”

You may click HERE for text of Senator Marshall’s amendment. Additionally, Senator Marshall recently spoke at a press conference about the Democrat-led bill, which will leave the U.S. with at least 15% fewer drugs developed and brought to market in the next 17 years. You may click HERE or on the image below to watch.

Background:

Senator Marshall’s amendment excludes two categories of drugs from government-controlled pricing. This includes Medicare’s six protected classes and those approved by the U.S. Food and Drug Administration’s Breakthrough Therapy designation. Both categories are intended to protect patients with mental illness, organ transplants, epilepsy, Parkinson’s Disease, cancer, Alzheimer’s, HIV, and other serious health conditions.  

Within his first two years, Senator Marshall took lowering health care costs head-on. First, he championed the bipartisan Ensuring Innovation Act that increases access to generic drugs and biosimilars while preserving innovation. This was one of the first bills that made it to President Biden’s desk to be signed itto law and it stops pharmaceutical companies from gaining additional market exclusivity based on slight tweaks to their existing medicine. Next, Senator Marshall secured nearly half a dozen policies in the Food and Drug Administration (FDA) Safety and Landmark Advancements Act, a package that reauthorizes the FDA’s user fee programs. Notably, he worked on several policies to improve and make drug development more efficient and less costly by allowing the use of real-world evidence to support the approval of drugs aimed to address serious conditions that fill an unmet medical need under the Accelerated Approvals Program.

He also helped introduce and pass the Accelerating Access to Critical Therapies for ALS Act to speed the development and approval of therapies for ALS and other rare neurodegenerative diseases. He helped introduce the legislation last Congress and was signed into law December 2021.

Republican lawmakers have a comprehensive solution to drug pricing. Senator Marshall joined the Finance Committee Ranking Member, Senator Crapo (ID) in reintroducing the Lower Costs, More Cures Act. The legislative package contains bipartisan proposals that can lower out-of-pocket patient spending, protect access to new medicines and cures, strengthen transparency, and champion competition. The legislation includes more than 20 policies to address medicine affordability. Of note, it increases insulin affordability for Medicare seniors with diabetes by limiting their out-of-pocket costs to $35 and establishing an annual out-of-pocket cap of $3,100 for seniors. The package also includes his bipartisan GENE Therapy Payment Act, legislation he wrote while serving in the U.S. House of Representative. The bipartisan bill would establish a value-based payment system so that Medicaid beneficiaries have quality access to breakthrough treatments like gene therapy.

To learn more about the Lower Costs, More Cures Act, click here.

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