Sen. Bill Cassidy (R-La.) proposed ways to modernize the Food and Drug Administration in a report released on Feb. 17.

“While many parts of FDA work well, unnecessary bottlenecks slow patients and consumers getting the products they need,” Cassidy, a doctor and chairman of the Senate Health, Education, Labor, and Pensions Committee, said in the 18-page document. “Ultimately, it should be easier to make Americans healthy by empowering them with the tools and information they need to make healthy choices and live better lives.”

One recommendation is to eliminate barriers and opacity with the FDA’s process for reviewing applications for new products. According to the report, executives facing the process report varying standards, depending on which reviewers are involved, along with perceived disconnect between reviewers and senior FDA officials.

Cassidy noted that in 1997, Congress mandated the FDA take the “least burdensome” approach to regulation, or requiring only the minimum information necessary to properly address issues and having a focus on efficiency.

“To improve predictability, Congress and FDA should consider how to apply this principle to other product categories while maintaining patient safety and evidentiary standards,” he wrote. “Additionally, as Congress considers reforms, proposals should ensure there is accountability, transparency, and flexibility in the review process to meet the agency’s resources.”

Among the other proposals are: Looking at revamping thresholds for clinical trials and instances that companies can use real-world evidence in lieu of trials; making sure the FDA is using artificial intelligence in a way that “guards against mission-critical risks without stifling new discoveries;” largely refraining from imposing clinical holds on testing for therapies aimed at rare diseases; and improving dialogue with companies seeking approval for their products.

Cassidy also said that Congress should take multiple steps with regard to the agency, including passing bills that limit citizen petitions to the FDA and creating a new streamlined pathway that would enable cutting-edge products to more quickly reach consumers.

“While FDA has made progress, there remains enormous potential for the agency to support better and more affordable products for patients,” he said in conclusion.

Sen. Bernie Sanders (I-Vt.), the ranking member on the Senate Health Committee, did not return a request for comment by publication time.

At the Department of Health and Human Services, the FDA’s parent agency, officials appreciate the committee’s engagement on modernizing the FDA, a spokesperson told The Epoch Times in an email.

“Many of the themes outlined in the white paper align with work already underway at the agency and we look forward to continued engagement with the Committee to advance these ideas in the legislative process where we share priorities,” the spokesperson said.