As prepared for delivery.
“Thank you all for being with us. Today’s hearing will focus on innovation and some of the biggest roadblocks.
“We can all agree that America is the global leader of innovation, and the government should do everything it can to foster an environment that promotes greater innovation and patient access to innovative care.
“Unfortunately, we have all seen the news about recent examples of the government getting in the way:
- CMS’s restrictive coverage mandate for new, promising Alzheimer’s treatments;
- repealing the Trump admin MCIT rule with no replacement still;
- CMMI considering changes to coverage for Part B drugs that received FDA accelerated approval;
- USTR’s TRIPS waiver of critical IP protections for COVID vaccines; and
- so-called government negotiation of drug prices implemented by the Inflation Reduction Act
“In fact, just last week, data was released on a third promising Alzheimer’s drug showing it significantly slowed disease progression, but it will still be subject to the current, restrictive CMS mandates.
“The landscape has changed since June 2021 when Aduhelm was approved, but CMS refuses to reconsider coverage despite evidence showing their effectiveness in treating Alzheimer’s in its earliest stages.
“This is progressive, and the 6.7 million Americans living with it don’t have time to wait for CMS to come to its senses. This delay means many of these patients will progress beyond the point of the drugs being usable.
“In fact, in April, 26 bipartisan attorneys general from across the country sent a letter to Secretary Becerra and Administrator Brooks-LaSure calling on CMS to reconsider the requirements for covering these drugs, and I am submitting this letter for the record.
“As someone who saw firsthand the devastating effects of Alzheimer’s on my own father – and because I represent one of the oldest districts in the nation – this issue is of personal importance to me.
“In fact, in an effort to push CMS to do their job the right way, I reintroduced the bipartisan MERIT Act earlier this year to require CMS to consider each new drug on its own rather than as a class.
“FDA approval, whether traditional or accelerated, is full approval, and CMS should not be second-guessing the scientists at the FDA who granted approval in the first place.
“Additionally – as the former ranking member of the Trade Subcommittee – the TRIPS waiver for COVID vaccines is of particular concern to me given it directly undermines the mission of the USTR to vigorously protect American interests abroad, including protecting intellectual property rights.
“I have led multiple letters signed by my House colleagues opposing the TRIPS waiver, because there is no reason to continue pursuing such a waiver, it will only allow our adversaries to access critical IP that they have no reason to possess.
“The pandemic is over, the public health emergency ends tomorrow, and we have an overabundance of vaccine doses that are available for people in the farthest reaches of the earth.
“Unfortunately, the physical infrastructure doesn’t exist to get the doses to those people. Instead of giving away IP to other countries, we should be helping teach them how best to update their outdated infrastructure.
“If we continue down this path of working against innovators, we will start falling behind countries like China that are willing to do whatever it takes to gain power and pass us by.
“Finally, I want to mention CMMI, because despite having innovation in its name, it is one of the greatest barriers to actual innovation in health care.
“Since 2010, CMMI has released many demonstration projects, some of which were mandatory, but has not realized savings greater than the amount of money Congress has spent on the agency.
“We all want Medicare and Medicaid to run efficiently, but it is time that Congress reasserts its control over these decisions and works to truly help promote American innovation.
“There is bipartisan interest in many of these topics, and we should find bipartisan solutions to fix them. I am in the business of trying to get to yes, so I would like to challenge my friends on the other side of the aisle to work with us on ways to unleash American innovators.
“We all want America to lead the world in medical innovation and we want Americans to have access to the newest, best groundbreaking treatments as soon as possible. I hope we can leave this hearing today with a renewed sense of bipartisanship and willingness to work together on policies that protect and enhance innovation.”