House Speaker Nancy Pelosi released a plan today on changes to the way the U.S. values and reimburses prescription drugs, including in the Medicare program, which will have significant impacts on clinical research in the future. The plan would enable direct price negotiation on up to 250 drugs, implement new liabilities in the Medicare program, new price controls, and the hammer of a 65-95% new tax. These policies will impact investment in clinical research and innovation may suffer as a result. The Academy of Physicians in Clinical Research (APCR) released the following statement regarding the proposed changes.
Washington, DC (September 19, 2019) – The Academy of Physicians in Clinical Research (APCR) released the following statement regarding Speaker of the House Nancy Pelosi’s proposed changes to the Medicare program:
“Today, America remains a leader in medical science thanks to a robust research and development pipeline dedicated to finding the next generation of cures. More than 100,000 clinical trials are ongoing thanks to the work of thousands of physicians who help design and execute this research. It is vital work toward improving the overall heath outcomes and quality of life for all patients, requiring proper incentives for continued investment, resources and time. We remain concerned that Speaker Pelosi’s drug pricing proposals will disrupt research and stymie future medical progress.
Particularly concerning to researchers is the plan’s significant shift in liability, similar to the Senate Finance Committee package, which may ultimately undermine available resources for future R&D innovation. The proposed change in liability in the catastrophic phase of Medicare Part D could shift market focus away from medicines in areas of unmet need, directly impacting the resources available to researchers, universities, and other research institutions. Notably, this poses a significant threat to jobs for physicians responsible for clinical trials, which bring innovative therapies to the patients who need them.
Additionally, Speaker Pelosi’s proposed price controls and international reference pricing within the Medicare program may regressively impact our most innovative medications and breakthroughs, potentially eroding patients’ access in the process. We’ve seen this happen before. When countries intervene to set broad caps on drug prices, investment in research and innovation suffers as a result.
There are other, far more direct ways to address patients’ needs that Congress can take up, such as reforming the pharmaceutical supply chain. It’s a false choice between innovation and reduced prices at the pharmacy counter. Congress must reject this, and any other plan that asks patients to make this unnecessary sacrifice.”