Chair of the Health Subcommittee, Buchanan, to Hold Public Hearing on Policies That Impede Innovation and Patient Access.

Thank you all for joining us. Today’s hearing will focus on innovation and some of the biggest obstacles. Everyone agrees that America is the world leader in innovation. Governments should do all they can to foster an environment that fosters greater innovation and patient access to innovative care.

You’ve probably seen the news in the news about a recent case where CMS is mandating coverage limits for promising new treatments for Alzheimer’s disease. No. CMMI is considering scope changes for Part B drugs that have received FDA accelerated approval USTR’s TRIPS key intellectual property protection waiver for novel coronavirus vaccines.” In fact, just last week published data showing that a third promising Alzheimer’s drug slows disease progression significantly, but it will still be subject to current restrictive policies, CMS mandates.

“The situation has changed since Aduhelm was approved in June 2021, but despite evidence of efficacy in the initial treatment of Alzheimer’s disease, CMS has refused to reconsider reimbursement.” Alzheimer’s is progressive, and the 6.7 million Americans who live with it don’t have time to wait for a better understanding of CMS.

“In fact, in April, 26 bipartisan Attorneys General across the country sent letters to Chief Becerra and Chief Brooks Rashua asking CMS to reconsider the requirements for these drugs. I submit this letter for the record. As someone who has seen first-hand the devastating effects of Alzheimer’s disease on my own father, and because I represent one of the oldest neighborhoods in the United States, this issue is personally important to me.”

“In fact, in an effort to encourage CMS to do its job the right way, I reintroduced the bipartisan MERIT Act earlier this year and gave CMS a class of each new drug. FDA approval, whether conventional or accelerated, is a full approval, and CMS was the first FDA science to grant approval.”

“Additionally, as a former executive on the Commerce Subcommittee, the TRIPS exemption from the COVID-19 vaccine vigorously protects U.S. interests abroad, including the protection of intellectual property rights. This is of particular concern to me, given that it directly undermines the USTR’s mission to protect.”

“I have led several letters signed by colleagues in the House of Representatives opposing TRIPS waivers, because there is no reason to continue to pursue such exemptions, as it would only allow access to critical IP that our adversaries have for no reason.” The pandemic is over, the public health emergency ends tomorrow. There is an overabundance of vaccines available to people in the farthest corners of the planet.

“Unfortunately, the physical infrastructure does not exist to deliver doses to these people. Instead, we should help teach them how best to update their outdated infrastructure. If we continue down this path against the innovators, they will come to power and overtake us. We will start to fall behind countries like China that will stop at nothing.”

“Finally, I would like to touch on CMMI, because despite innovation in the name, it is one of the biggest barriers to real innovation in medicine. Since 2010, CMMI has announced a number of demonstration projects, some of which were mandated, but the savings have not exceeded the amount Congress spent on the agency.”

“We all want Medicare and Medicaid to run efficiently, but it’s time for Congress to reaffirm its control over these decisions and work to truly help advance innovation in America. Many of these agendas have bipartisan concerns and we need to find bipartisan solutions to solve them.”

“I would like to challenge my friends in the United States to work with me on how to unleash America’s innovators. We all want America to lead the world in medical innovation, and we want the American people to get involved as soon as possible. We want to give you access to the latest and greatest breakthrough therapies, and we can leave today’s hearings with a renewed bipartisan mindset and a willingness to work together on policies that protect and enhance innovation. I hope that.”

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