Kelly and Colleagues Introduce Bill to Streamline FDA Process to Develop Drugs, Medical Products

Sens. Collins, Sinema co-sponsored the bill and Reps. Lesko, O’Halleran introduced companion legislation in the House.

Today, Arizona Senator Mark Kelly introduced bipartisan legislation, co-sponsored by Senators Susan Collins (R-MI) and Kyrsten Sinema (D-AZ), to streamline the federal government’s process to develop drugs and other medical products by continuing the Food and Drug Administration’s public-private partnerships with universities and non-profit organizations. The bipartisan bill will also reauthorize the Critical Path Public-Private Partnerships, a Tucson-based non-profit, through fiscal year 2027. 

Companion legislation was introduced in the House by Representatives Tom O’Halleran (D-AZ-01) and Debbie Lesko (R-AZ-8).

“Our bipartisan bill will serve patient needs by streamlining the process needed to get medical drugs from development to your medicine cabinet,” said Senator Kelly, a member of the Senate Special Committee on Aging. “As we continue our work to bring down health care costs for Arizonans, our bill takes an important step towards ensuring that patients have more choices.” 

There is simply no investment that promises greater returns for America than our investment in biomedical research. Diseases such as diabetes, cancer, and Alzheimer’s, with their devastating human and financial costs, are powerful examples of the urgent need to keep our momentum in research funding going,” said Senator Collins. “The Critical Path Institute has fueled collaboration and innovation that has led to effective means of prevention, treatments, and cures. By reauthorizing this public-private partnership, we can continue to support this promising research.”

“I’m proud to support Arizona’s C-Path Institute in its mission to boost efficiency, cut costs, and reduce the risks innovators and researchers face to increase the number of life-saving, FDA-approved treatments for Arizona patients and families,” said Senator Sinema.

“I was pleased to introduce the House companion of this important, bipartisan legislation that will fund critical drug safety and manufacturing opportunities that will lower care costs and save lives through new research and innovation,” said Representative O’Halleran. “I’m pleased to see our bill included in the bipartisan FDA reauthorization and looking forward to working with my colleagues to cement our growing state as a leader in medical product development.”

“The Critical Path Initiative has driven the innovative use of consensus science to streamline and de-risk medical product development,” said Kristen Swingle, Interim President and Chief Operating Officer at C-Path. “We’d like to thank Senator Kelly and Senator Sinema for taking the lead on reauthorizing this legislation, demonstrating their support for initiatives which accelerate the approval of novel medical products with positive impact on public health.”

The Critical Path Initiative strives to accelerate the development of medical products while also reducing product development costs by creating new data, measurement, and methods standards used to scientifically evaluate the safety and efficacy of new products. The Critical Path Institute, also known as C-Path, achieves this by providing the legal and scientific infrastructure to create a neutral, pre-competitive forum in which industry leaders, academic researchers, scientists, regulators, and patient groups work together to accelerate the development and approval of new products and therapies. Congress initially enacted this program through the Safe and Effective Drug Development Act in 2007 and has reauthorized it twice.