The Lupus Research Institute (LRI) welcomes the opportunity to represent the lupus community in the open dialogue afforded by two initiatives released by the U.S. House of Representatives and the U.S. Senate last week that aim to transform the process of bringing better treatments and cures to patients faster.
The 21st Century Cures Act discussion draft led by the House Energy & Commerce Committee reflects the valuable feedback elicited in a highly transparent process from patients, healthcare providers, regulators and researchers nationwide on how Congress can help to accelerate the discovery, development, and delivery of new therapies and cures. The next phase toward #Cures2015, the draft Bill solicits further feedback on proposals to: incorporate patient perspectives into FDA review of potential treatments; support technological scientific innovation; modernize the clinical trial process; streamline the regulatory review process; and encourage improved manufacturing technologies.
The Senate Health, Education, Labor and Pensions (HELP) Committee released a similarly detailed report “Innovation for Healthier Americans” that outlines parallel areas of focus for future legislation to improve drug development and medical device development and processes at the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH). The report looks at ways to improve clinical trials and product and drug review policies. The HELP Committee will set up a bipartisan work group and hold a series of hearing on the concepts.
The Lupus Research Institute is reviewing both documents to bring the voice of lupus patients into the next phase of discussion. We commend both sides of Congress for making improved medical care a legislative priority and look forward to working together to incorporate patient input as a key component in the urgent drive to provide better treatments and a cure for lupus as the prototypical autoimmune disease.