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Chairman Smith Opening Statement: Hearing on Examining Policies that Inhibit Innovation and Patient Access

May 10, 2023

As prepared for delivery.

“Chairman Buchanan, Ranking Member Doggett – thank you for the opportunity to share a few thoughts on how current White House policies are threatening medical innovation and patient access to care.


“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 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 – and access to – the next drug, device, or treatment. Unfortunately, that is what we are seeing today with decisions made by agencies such as CMS.


“Broadly restricting coverage for Alzheimer’s treatments – the first approved in nearly 20 years – is a devastating blow to the patients and caregivers relying on new innovations. Importantly, these restrictions are disproportionately felt by those living in rural America who don’t have access to qualifying clinical trials.


“I applaud Subcommittee Chairman Buchannan’s work on this issue, and I hope that in the light of continued positive data, such as the study released last week, CMS will reconsider this decision.


“Similarly, I have concerns that the CMS Innovation Center’s proposed policy to devalue accelerated approved drugs will slow access to breakthrough innovation, such as many cancer therapies.


“Congress shares much of the blame, too. The Inflation Reduction Act established a new drug price-control scheme. We all want to make medications more affordable. But making Washington the price-setter will only lead to fewer cures and less access to them.


“Experts warn that price controls will lead to 135 fewer cures and discourage the development of generic and biosimilar competition – a far more patient-friendly approach to lowering drug prices.


“Patients relying on breakthrough medical devices are also facing uncertainty after a Trump-era innovative coverage rule was repealed by this Administration. I know members on both sides of the aisle will be closely watching for a meaningful replacement.


“Lastly, the Biden Administration’s decision to waive IP protections for vaccines, and potentially expand to therapeutics and diagnostics, is setting a dangerous precedent and opening the door for countries like China to steal our innovation.


“Right now, there are 322 different medicines being developed to treat cancer, 192 for rare genetic diseases, 83 for Alzheimer’s disease, and hundreds of others. Patients cannot afford Washington’s anti-innovation policies. I look forward to working with all my Ways and Means colleagues to promote access to these future cures.


“I yield back.”