On Wednesday, the House Ways and Means Subcommittee on Health held a hearing examining policies that inhibit medical innovation and reduce patient access to new therapies. The Subcommittee discussed the Biden Administration’s decisions to limit access to new and innovative treatments for patients through Democrat price-controls, coverage restrictions in Medicare, devaluing accelerated approved drugs and breakthrough medical devices, and allowing China to steal American intellectual property.
Washington Having “Chilling Effect” on Development and Access to Innovative Drugs
Chairman Jason Smith (MO-08) condemned the White House policies that threaten medical innovation and patients’ access to care. Specifically, the Administration’s decision to block access to breakthrough Alzheimer’s drugs, establish a new price- control scheme through the Inflation Reduction Act, and make it easier for China to steal American innovation.
Chairman Smith (MO-08): “Across America, millions of patients are anxiously hoping for new breakthrough cures and devices that will improve their quality of life, or even give them more years with their loved ones. The scientists that research these cures, they rely on Congress to craft policies that support innovation. Patients deserve peace of mind that these therapies will be available to them when approved. Poor policymaking, through both Congress and executive action, however, can have a chilling effect on the development of an access to the next drug, next device or treatment.”
Buchanan: Americans with Alzheimer’s Live One Day at a Time
The Centers for Medicare and Medicaid Services decision to block access to an FDA- approved Alzheimer drug could have dire consequences for patients, warned Subcommittee Chairman Vern Buchanan (FL-16). Tony Gonzales testified about how that decision would impact access to treatment and quality of life for the millions of patients living with Alzheimer’s disease, like him.
Health Subcommittee Chairman Buchanan (FL-16): “Just taking the drugs, even if you get another six months of your life, if you start now, could make a gigantic difference. There’s a lot to be said for that. I want to turn it over to you and give you a little time to talk us through that.”
Mr. Gonzales: “Eight months. I wake up with one day. I wake up with one day. And so you’re looking at me and saying, ‘What does eight months mean?’ If you ever spent some time with me, you’d see that in that one day I pack a lot. I packed time for family, friends, my community, my government, my religion, in one day. You give me eight months, and see what I’ll do. See what many of these people will do that are not getting access to these drugs, and they’re slipping away every day.”
Seniors with Cancer Should Have Access to the Best Health Care Possible
Rep. Blake Moore (UT-01) highlighted President Biden’s decision to rescind a Trump- era rule, the Medicare Coverage of Innovative Technology (MCIT), that ensured millions more seniors had faster access to innovative medical devices.
Rep. Moore: “We’ve also witnessed the consequences of MCITs withdrawal in Utah… There’s a local company with an FDA breakthrough device designation for Parkinson’s patients. And it lost a significant amount of funding following the repeal of MCIT. This company has struggled to replace the lost funds. And as a result, Parkinson’s patients may never have access to a product that could improve their motor function. My colleagues and I firmly believe that a pathway to MCIT is essential for Medicare coverage for innovative technologies…can you share why a modification of the current coverage pathway is insufficient and why a pathway similar to MCIT is needed?”
Dr. Makower: “I think there’s a misunderstanding that when a technology is deemed a breakthrough, it really means a product has the potential to have a major impact on a debilitating or life-threatening disease. After that designation then there is a substantial amount of evidence that is necessary to clear FDA. Very few companies actually make it..to the FDA approval. Once they’ve finally cleared that gauntlet to have proven themselves safe and effective with the FDA especially for breakthrough technologies, that’s where the opportunity is to give patients access to it. And I think as evidenced by our survey, innovators are very open to continue to generate evidence development while it’s available to patients and I think the proposal that’s been put forward which I think is a very supportable one which will give patients access as soon as they’ve available by FDA while continuing to collect any necessary evidence that CMS may require.”
Democrats’ Inflation Reduction Act Stopped Development of New Drugs
The Inflation Reduction Act will prevent the development of as many as 135 new drugs. Rep. Kevin Hern (OK-01), exposed how the IRA would slash the development of new cures and undercut access for patients.
Rep. Hern: “Dr. Lakdawalla, can you comment on the recent changes to rare disease drug policy and what impact do you anticipate?”
Dr Lakdawalla: “It’s likely there will be reduction in innovation in rare disease because follow on indications are now potentially penalized under the IRA. It’s also the case more generally there will be reductions in incentives to innovate. It’s notable though that rare disease often features very high unmet need for patients. And as an economist, I can tell you that means the value of any given health improvement is great because patients have so little health that even a given relatively little modest amount of health can be quite valuable. That needs to be accounted for in the way CMS sets maximum fair prices to at least mitigate some of these issues for rare disease where value is at a premium.”
“We’re at a Crisis Point”: Cancer Drug Supply Crisis Made Worse by Inflation Reduction Act
The Inflation Reduction Act unfairly penalizes small molecule drugs through early Medicare price setting, disincentivizing the development of drugs that can treat neurological diseases and certain brain cancers. Even without the Democrats’ defacto restrictions on drug development, cancer drugs are in short supply. Rep. Brian Fitzpatrick (PA-01) discussed how those policies will make it more difficult for cancer patients to access the treatment and cures they need to stay alive.
Rep. Fitzpatrick: “What do you believe the intent in the [Inflation Reduction Act] IRA was this disparity between biologics and small molecules?”
Mr. Okon: “I live in the world of cancer. I think there’s a basic misunderstanding of looking at a drug as a drug as a drug. A small molecule is not as new, innovative…as a biologic, but in cancer, they’re essential. Right now, we’re even dealing with cancer drugs that are in short supply that are generic drugs that have been used for over 20 years. We’re at a crisis point, literally today. We’re at a crisis point.”