Washington, D.C. – U.S. Senator Michael Bennet (D-CO) today applauded the passage of bipartisan legislation to reauthorize the Federal Drug Administration’s (FDA) user fee programs for drugs and medical devices. The legislation includes three Bennet-led bills to support the development of innovative and promising cancer drugs for children, enhance clinical trials, and improve the safety of medical devices.
“This legislation is critical to ensuring Coloradans and all Americans are able to access the most innovative drugs and medical devices. This is particularly important for families with children who are suffering from cancer,” Bennet said. “I commend my colleagues for working in a bipartisan way to ensure that we continue modernizing the FDA and bringing critical treatments to those who need them most.”
The FDA’s user fee programs account for about half of the agency’s annual budget and helps speed the review of new drugs and medical devices.
The following Bennet measures were included in the legislation:
A bill co-sponsored with Senators Marco Rubio (R-FL), Chris Van Hollen (D-MD), and Cory Gardner (R-CO) to update the Pediatric Research Equity Act (PREA) to reflect the latest advances in cancer drugs. PREA was enacted by Congress in 2003 to address the scarcity of information about how to treat children with drugs developed for adults, and therefore develop pediatric data during drug development. Although PREA has resulted in new information on how to treat children for a multitude of drugs over the years, there are still limited pediatric studies for cancer drugs. The RACE for Children Act would close that gap and prompt companies to study the most innovative breakthroughs in cancer for children.
A bill co-sponsored with Senators Orrin Hatch (R-UT), Richard Burr (R-NC), and Bob Casey (D-PA) to: 1) enhance clinical trials by authorizing a public meeting between the Food and Drug Administration (FDA) and National Institutes of Health (NIH) to discuss clinical trial criteria with the aim of including a wider range of patients; 2) require the Government Accountability Office (GAO) to complete a study on the challenges of expanding clinical trials and provide recommendations; 3) provide guidance about eligibility for clinical trials following the publication of the GAO study; 4) improve the institutional review board assessment of individual pediatric and adult patient expanded access protocol and how the institutional review boards may facilitate the use of the protocols; and 5) allow drug manufacturers and sponsors to make their expanded access policies available during phase 1 of study, rather than phase 2 or 3, for drugs going through the breakthrough therapy, fast track process, or regenerative advanced therapy pathways. This legislation will provide needed direction to improve clinical trials by expanding eligibility to high-risk patients. It will also create a more streamlined and transparent process for patients who still don’t qualify for a clinical trial, but need access to experimental treatments.
A bill co-sponsored with Senator Johnny Isakson (R-GA) to establish a risk-based inspections process to ensure the frequency and nature of inspections are more consistent around the world. To do this, it will enhance communication between the FDA and companies so they may address quality and compliance issues more efficiently. By modernizing the medical device inspections process, resources can be directed to the most high-risk products and safety concerns can be better identified and remediated.