Bill Cassidy Releases His Own Plan to Overhaul the FDA

Sen. Bill Cassidy released his own plan to overhaul the Food and Drug Administration on Tuesday, calling for changes in regulatory oversight, “novel clinical trial approaches” and the incorporation of artificial intelligence in the pharmaceutical review process to speed up the approval of new drugs.

The report detailed 15 recommendations to help the agency “modernize” and avoid what Cassidy referred to as “unnecessary bottlenecks” that “slow patients and consumers getting the products they need.”

“Biomedical innovation holds enormous promise for the American people,” Cassidy wrote in the 18-page report. “But ‘innovation’ is meaningless unless it creates products that actually help patients. Discoveries that never leave the lab help no one.”

It’s unclear how seriously the recommendations will be taken at the agency, given the recent animosity between Cassidy and Robert F. Kennedy Jr., the secretary of Health and Human Services. Cassidy’s office did not respond to a request for comment on when work on the report began and whether there had been any buy-in for the ideas at HHS.

Cassidy voted for Kennedy’s confirmation last year, but has since spoken out against a number of changes championed by Kennedy, most notably his purging of the Centers for Disease Control and Prevention’s vaccine advisory board and installation of vaccine skeptics on the panel.

Kennedy revealed over the weekend that he has enlisted the help of one of his critics, former FDA Commissioner Dr. David Kessler, in rethinking the agency’s “General Recognized As Safe” exemption, which allows certain ingredients to bypass the FDA review process. Kessler has long pushed for the removal of GRAS exemptions for corn syrup and dozens of other sweetening agents that he believes may be part of the reason for America’s obesity epidemic.

In his report, Cassidy said a review of GRAS exemptions found that since 2010, the FDA only cited an ingredient for not meeting the requirements 15 times. The designation is a contributor, Cassidy said, to the FDA’s “challenges in keeping pace with advances in food science that can provide American consumers with more healthy food options, like produce with more nutrients.”

Cassidy said his report aims to “initiate a collaborative, bipartisan process for reforms to strengthen the FDA” and said he “looks forward to coordinating with FDA under its new leadership to promote patient access, accelerate U.S. competitiveness, and improve the health of American families.”

When it comes to regulating the cost of generic drug prices, Cassidy credited the congressional legislation mandating this regulation, the Hatch-Waxman Act, but said “abuses still occur.” The Hatch-Waxman Act was introduced in 1984, Cassidy noted, before the prominence of “drug-device combinations,” such as inhalers or EpiPens, an area the FDA has failed to address.

“Despite decades of requests for more certainty regarding patent listing obligations for drug-device combinations, FDA has not weighed in,” Cassidy wrote. “Instead, the Federal Trade Commission has stepped into the void, usurping FDA’s jurisdiction and creating harmful uncertainty in the process.”

The FDA has fallen behind in the technological race, Cassidy wrote in the report, detailing how the agency’s unwillingness to integrate cloud-hosted technology has hampered its ability to digitally monitor health systems.

“For software used both as and in medical devices, FDA has struggled to develop a framework within current authorities with the appropriate flexibilities needed to regulate such dynamic and novel technologies,” the report read. “New software approaches often fit awkwardly, or do not fit at all, into FDA’s traditional device frameworks.”