BIPARTISAN FDA REAUTHORIZATION ACT INCLUDES AMENDMENTS OFFERED BY REP. RYAN COSTELLO AND REP. SCOTT PETERS
Washington, D.C. – Bipartisan legislation that advanced through the Energy and Commerce Committee today included amendments regarding patient safety that were offered by Rep. Ryan Costello (R-PA) and Rep. Scott Peters (D-CA).
The Food and Drug Administration (FDA) Reauthorization Act builds on years of work that aims to develop treatments, lower drugs costs, and prioritize patient safety. An essential part of the legislation allows the FDA to collect user fees from pharmaceutical companies in order to advance its important mission. Since the first pharmaceutical drug user fee agreement was passed in 1992, these agreements have taken proven steps to expedite drug development and maintain patient-safety.
“With the passage of the FDA Reauthorization Act through the Energy and Commerce Committee today, we are one step closer to helping to ensure the timely delivery of innovative treatments that can positively impact patients’ lives,” said Rep. Costello. “This legislation is also critical to our local economy in Pennsylvania, as it will make sure our businesses remain competitive and keep up with emerging public health needs. Thank you to Rep. Peters for working with me on offering amendments that prioritize patient safety.”
“Passing this FDA reauthorization through the committee is an important step to support job creation in my district in San Diego and in local economies across the country. These user fee agreements will help accelerate approvals for devices and drugs that are improving and saving lives every day,” said Rep. Peters. “This bill also includes important provisions to accelerate the reviews for generic drugs that have no competition, and move the medical device industry to a risk-based inspection model that will provide manufacturers with greater certainty. I thank my colleague Rep. Costello for working with me to add our amendments that put patient safety and patient health first, and look forward to continuing to work in a bipartisan manner to reauthorize the FDA and give our innovators the certainty they need.”
The amendments offered by Reps. Costello and Peters focused on the safety of medical devices and diagnostic imaging technology.
Based on Peters and Costello’s Medical Device Servicing Safety and Accountability Act, Rep. Costello offered an amendment that was the result of a bipartisan dialogue focused on addressing concerns about the quality, safety, and efficacy of medical devices that have been subject to repairs, refurbishing, and reconditioning by third-parties. This amendment would require the FDA to report back to the Energy and Commerce Committee outlining the feedback it has received over the past year-and-a-half, as well as details on the steps that the FDA believes the Committee should take in order to protect the public health and ensure that medical devices, which have undergone service, maintenance, and refurbishing, maintain the same high standards of quality, as initially certified by the FDA.
“Improperly-serviced medical devices can lead to malfunctions that could cause a misdiagnosis or a missed diagnosis, which could cause care to be delayed, or worse, lead to severe patient injury or death,” Rep. Costello said during the Energy and Commerce Committee markup. “Simply put, this amendment sets forth a plan of action for the FDA to complete its work on this issue and outline what must be done in order to ensure the quality, safety, and continued effectiveness of medical devices.”
The amendment would not impose any new requirements on third-party servicers, but continues the fact-finding effort the FDA began in early 2016.
Rep. Peters’ amendment, based on Peters and Costello’s Fostering Innovation in Medical Imaging Act, will make groundbreaking imaging procedures available to patients more quickly and support innovation and job creation in medical imaging. The amendment creates a clear FDA regulatory pathway for new cutting-edge procedures that use already-approved contrast agents – or drugs that are injected to improve medical imaging – in new ways. The current regulatory process requires contrast agents to be re-approved for use in new body parts, delaying the approval of innovative medical imaging procedures that can better diagnose patients.
“This amendment will make cutting-edge medical imaging procedures available to patients more quickly and support innovation in the medical imaging arena, which creates high-paying jobs and grows the economy in places like my district in San Diego,” said Rep. Peters.