Press Release

#Path2Cures Requires Collaboration and Transparency


Health Subcommittee Reviews Barriers to Communication Among All Involved in Discovery, Development, and Delivery Cycle

WASHINGTON, DC – The House Energy and Commerce Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), today held a hearing, 21st Century Cures: Examining Barriers to Ongoing Evidence Development and Communication. Subcommittee members and witnesses discussed the discovery, development, and delivery cycle and the importance of transparent collaboration in that cycle in order to bring better cures and treatments to patients more quickly.

Full committee Chairman Fred Upton (R-MI) commented, “Different uses for drugs or devices are constantly being discovered by physicians, researchers, and scientists in academia and industry. Particularly in the context of devices, improvements are continually made to products based on new evidence being developed about how certain patients are responding to certain treatments, technologies, or combinations thereof. We must work to ensure that our regulatory and reimbursement policies encourage this iterative process and do not stifle innovation.”

Pitts asked Mary Grealy, President of the Healthcare Leadership Council, about her testimony that said, “there are certain aspects of HIPAA and privacy laws in general that warrant policymaker review and discussion.” Grealy told Pitts, “The key here is to make sure that we have an appropriate balance between protecting patient information, and we believe very strongly in that, but we also don’t want to erect barriers to having access to that data.”

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Michael Mussallen, Chairman and CEO of Edwards Lifesciences explained that the company’s “recent experience with the development of an innovative heart valve replacement therapy, which enables a team of physicians to replace a patient’s aortic heart valve without open-heart surgery, has provided us a unique perspective on the current regulatory process.” Mussallem noted that this device was approved in the United States four years later than it was in Europe.

Mussallem offered three recommendations to break down existing barriers to innovation: “Evidence development mechanisms can be improved to reduce costs and delays; Economic incentives need to be aligned with promoting innovation; FDA’s vision to improve the regulatory process must be accelerated.”

Gregory Schimizzi, M.D., Cofounder of Carolina Arthritis Associates, testifying on behalf of the Alliance for Specialty Medicine, added, “current practices at both the FDA and CMS may be inappropriately hampering the exchange of information and making it difficult for physicians to receive the information they need to make valuable treatment decisions.”

Josh Rising, MD, MPH, Director of Medical Devices at Pew Charitable Trusts added, “Clinical trials are the gold standard of medical evidence. They are also the single largest contributor to the cost and length of product development. The key to facilitating innovation of new drugs and devices is to collect the information faster and cheaper, and ensure patients, providers, regulators and payers have the data they need. Registries, large databases that collect information over time on a group of patients treated for a particular medical condition, are one way to accomplish this.” Rising noted recent work conducted by Pew that found, “registry findings and reports should be publicly released on a regular basis, and that the governance, operations, and financing should be made publicly available. FDA, the Centers for Medicare & Medicaid Services (CMS) and other stakeholders should encourage the use of registries that meet these criteria.”

The 21st Century Cures initiative will continue tomorrow with a roundtable to discuss personalized medicine.


Health (113th Congress)
Press Release