releases: https://www.donnelly.senate.gov/newsroom/press/donnelly-announces-bipartisan-medical-innovation-agenda
Data license: MIT · Data source: dwillis/congress-press
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| https://www.donnelly.senate.gov/newsroom/press/donnelly-announces-bipartisan-medical-innovation-agenda | Donnelly Announces Bipartisan ‘Medical Innovation Agenda’ | 2015-10-21 | 2015 | 2015-10 | Democrat | House | IN | Joe Donnelly | D000607 | www.donnelly.senate.gov | legacy | Donnelly Announces Bipartisan Medical Innovation Agenda Series of bills would encourage innovation, help accelerate development and review of new, life-saving drugs and devices Wednesday, October 21, 2015 Washington, D.C. Today, U.S. Senator Joe Donnelly announced his Medical Innovation Agenda to help ensure that patients have timely access to important drugs and medical devices proven to be safe and effective. The series of bipartisan bills that Donnelly introduced or supported as part of his Medical Innovation Agenda would streamline multiple Federal Drug Administration (FDA) approval processes to expedite the development of life-saving medicines and medical devices. The House of Representatives passed the 21st Century Cures Act earlier this year that includes some provisions similar to those in Donnellys Medical Innovation Agenda. As part of the package, Donnelly and Senator Cory Gardener (R-CO) introduced the FDA Regulatory Efficiency Act and the Rare Device Innovation Act. Both of these bills would streamline FDA processes to accelerate review. Donnelly said, As a global leader in the device and pharmaceutical industries, Indiana is at the forefront of life-saving research. We must continue to close the gap between the development of new drugs and devices and bringing safe and effective products to the public. Our policies should ensure safety and encourage innovation in order to make life-saving technologies and medicines available to the people who need them the most. Gardner said, Streamlining the medical device approval process will enhance the quality of healthcare for those living in Colorado and across America.While the Rare Device Innovation Act incentivizes the development of life-saving medical devices for those with rare diseases, the FDA Regulatory Efficiency Act allows the FDA to prioritize innovative medical devices that have the potential torevolutionizethe health care industry. It is commonsense policy, and I look forward working with Senator Donnelly and my colleagues to support patient-centered solutions that improve quality of care while bringing down costs. Kathy Heuer, Executive Director of the Indiana Medical Device Manufacturers Council (IMDMC), said, Technological innovation in the medical device industry that affects the delivery of healthcare has saved lives and improved the quality of life for patients worldwide. IMDMC applauds and supports Senator Joe Donnellys Medical Innovation Agenda because this critical bipartisan legislation would help modernize the FDA review process and expand the opportunity for patients to be able to access promising breakthrough medical innovations. The life sciences and pharmaceutical industries are vital to Indianas economy. According to a report by BioCrossroads and the Indiana Business Resource Center at the Kelley School of Business, Indiana University (IBRC), the life sciences industry has an economic impact on Indianas economy of almost $45 billion. For each job directly added in the life sciences industry in Indiana, another 2.7 jobs are created elsewhere in the states economy. According to calculations by the IBRC, the 50,000 jobs in the direct life sciences industry impact another 105,000 jobs in the broader Indiana economy. Key Legislation in Donnellys Medical Innovation Agenda The FDA Regulatory Efficiency Act, introduced by Donnelly and co-sponsored by Senator Cory Gardner (R-CO) Donnelly introduced the bipartisan FDA Regulatory Efficiency Act with Gardner that would help the FDA concentrate on high-priority activities by authorizing third parties to approve quality systems of device companies. Authorized-third parties could only approve changes that do not involve major technology changes or changes in the use of the product. The legislation would still hold companies accountable for their quality systems, while also helping to alleviate the overwhelmed FDA. The Rare Device Innovation Act, introduced by Gardner and co-sponsored by Donnelly Donnelly joined Gardner in introducing the bipartisan the Rare Device Innovation Act that would encourage the development of devices for diseases that affect only a small population in the United States. Often, companies are discouraged from developing devices for rare diseases because of the cost and time it takes to research, develop, and then push the device through the FDA review process. To make the development of devices for rare conditions easier, the FDA has a process that allows device manufacturers to avoid certain pre-market approval requirements. The legislation Donnelly is supporting would expand the size of the qualifying patient population from 4,000 to 8,000 people. S.1767, the Combination Product Regulatory Fairness Act of 2015 (introduced by Senators Johnny Isakson, R-GA, and Bob Casey, D-PA) Donnelly announced his support for the bipartisan Combination Product Regulatory Fairness Act of 2015, which would improve the review of combination products; those products that have properties of drugs, devices, or biologics, and currently do not fall under a single category for approval at the FDA. For example, a product used to kill bacteria in different locations within the body was designated as a combination product by the FDA because it uses both a UV Light source (a device) and a photoactive dye (a drug). While only the UV light demonstrated an ability to kill bacteria when each product was used separately, the two components used together were more effective. The legislation would allow the developer to work with the FDA to classify the product and create a clear process that includes: necessary clinical studies, timelines, and an evaluation of incremental risks from the product. Additionally, the legislation would allow the FDA to rely on prior findings of safety and efficacy for a previously approved drug component and rely on previously-approved pre-market approvals. Currently, when approving products, the FDA does not use prior findings of safety and effectiveness of components to evaluate a combination product. S.1077, the Advancing Breakthrough Devices for Patients Act of 2015 (introduced by Senators Richard Burr, R-NC, Michael Bennet, D-CO, and Orrin Hatch, R-UT) Donnelly announced his support for the bipartisan Advancing Breakthrough Devices for Patients Act of 2015 that would streamline the process for breakthrough innovations. When the FDA recognizes that a breakthrough device does not have an approved alternative, the device offers significant advances over existing alternatives, and is in the best interest of patients, the FDA will have a priority review of the device in order to bring it to market faster. S.1597, the Patient-Focused Impact Assessment Act (introduced by Senators Roger Wicker, R-MS and Amy Klobuchar, D-MN) Donnelly announced his support for the bipartisan Patient Focused Impact Assessment Act that would establish a patient engagement assessment tool designed specifically to further incorporate the voice of the patient into the drug review process. Innovative drugs must go through an extensive review to make sure they are safe and effective prior to becoming commercially available. Due to the complex nature of the development and review process, however, many patient advocates have called for more transparency and better collaboration with patients during the FDA consideration of a new drug application. If enacted into law, the bill would allow people living with uncommon diseases to play a more substantial role in weighing the advantages and disadvantages of potential medications, given their distinct experience in dealing with their conditions. Furthermore, the bill mandates that the FDA develop a clear, concise, and freely accessible checklist to inform the public of actions taken by drug reviewers. ### | 1 | 2026-03-30T12:14:52Z | 2026-03-30T12:14:52Z |