Top Republican eyeing FDA overhaul

[BumRushDaShow]

Source: The Hill

02/17/26 3:57 PM ET


Sen. Bill Cassidy (R-La.) on Tuesday unveiled his proposal for modernizing the Food and Drug Administration (FDA), calling on the agency to reform some of its practices and embrace innovations in order to get more products approved for patients.

In the report titled “Patients and families: Building the FDA of the future,” Cassidy, chair of the Senate Committee on Health, Education, Labor, and Pensions, lamented that “unnecessary bottlenecks slow patients and consumers getting the products they need.”

The first issue Cassidy cited in his report was the “reviewer lottery” system that companies report facing when trying to get their products approved by the FDA. Elsewhere in the report, he noted in particular how unpredictability in FDA reviews can impact drugs for treating rare diseases, so-called orphan drugs, by adding additional time and obstacles to approval.

“FDA teams can differ greatly in the extent to which they require testing or impose standards that are not calibrated to the relevant risks. The perceived disconnect between the forwardleaning rhetoric and thought leadership of senior FDA officials and cautious reviewer practice creates further unpredictability,” the report stated.

Read more: https://thehill.com/policy/healthcare/5741597-cassidy-report-fda-innovation/

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More "reinventing of the wheel". The fact that the agency had to go to a "User Fee" model in the early '90s to help fund reviews, means that Congress was refusing to adequately fund the agency from Budget Authority funds to do that type of work.

[3Hotdogs]

1. Mixed feelings- one one hand, we want new or improved drugs to reach our medicine cabinets. O.t.o h., who remembers

a drug called Thalidomide. It was quick approved in European countries and reach final approval in the U.S., much later. The result was that most of the birth defects that came from using the drug are experienced in European nations.

The Republican mantra is that regulations stifles the economy. But many regulations were developed to solve a problem or to address changes that occur in the environment or in response to new technology.

Traffic lights stifle my ability to get from point A to point B in an efficient manner. Lets deregulate traffic lights.

[BumRushDaShow]

3. "O.t.o h., who remembers a drug called Thalidomide."

Thalidomide (a drug). L-tryptophan (a food supplement). The Dalkon Shield & certain tampons (those latter 2 examples are considered medical devices).

And on and on.

People want "instant" and long-term health effects are rarely "instant".

What many don't understand is that there are panels of outside experts - similar to those highlighted during the COVID pandemic, which for that case were CDC's ACIP and FDA's VRBPAC - participate in the review process for FDA-regulated products.

Trying to reinvent a wheel that has been dicked with over the decades, particularly for political reasons, will solve nothing.

[Icanthinkformyself]

2. Yes,

new rules. We will be using leaches and bloodletting as remedies for all illnesses.

[Jilly_in_VA]

4. IIRC, he's a doctor (MD)

so maybe he has the right idea. But sometimes doctors are hand in glove with the pharmaceutical industry, so I dunno. However, if he could revise the layers of bureaucracy in the FDA, I'm for it.