In his report titled the "Patients and families: Building the FDA of the future," Cassidy laments that current review standards have created "unnecessary bottlenecks" that slow down access to newer medicines for patients.
He cited the example of orphan drugs, medications for diseases so rare that companies would have no financial interest in manufacturing them were it not for government intervention.
"Unpredictability in rare disease drug review, including across divisions and offices, creates unnecessary obstacles to investing the time and capital needed to develop these products. The individual divisions responsible for reviewing applications have widely divergent experience when it comes to rare diseases."
The Louisiana senator pointed to the FDA's Oncology Center of Excellence as an example of a federal office that has generated "predictable yet flexible" options for approving new cancer treatments.
He also touched on food industry standards, an issue of high importance for the "Make America Healthy Again" agenda.
For nearly 30 years, food manufacturers have not needed FDA review of ingredients if they are Generally Recognized as Safe (GRAS), though the agency retains the authority to review these products.
Health and Human Services Secretary Robert F. Kennedy Jr. recently discussed this "loophole" in an interview with CBS's "60 Minutes," saying that as a result, "This agency does not know how many ingredients there are in American food."
"While FDA has the authority to re-review GRAS determinations, it appears to seldom do so. Indeed, since 2010, FDA has determined that a food ingredient was not GRAS a mere 15 times," Cassidy's report stated. "Of those 15, FDA only made an official regulatory determination for one."
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