Welcome to DU! The truly grassroots left-of-center political community where regular people, not algorithms, drive the discussions and set the standards. Join the community: Create a free account Support DU (and get rid of ads!): Become a Star Member Latest Breaking News Editorials & Other Articles General Discussion The DU Lounge All Forums Issue Forums Culture Forums Alliance Forums Region Forums Support Forums Help & Search

BumRushDaShow

(167,657 posts)
Wed Feb 18, 2026, 03:25 AM 22 hrs ago

Top Republican eyeing FDA overhaul

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/



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.
4 replies = new reply since forum marked as read
Highlight: NoneDon't highlight anything 5 newestHighlight 5 most recent replies
Top Republican eyeing FDA overhaul (Original Post) BumRushDaShow 22 hrs ago OP
Mixed feelings- one one hand, we want new or improved drugs to reach our medicine cabinets. O.t.o h., who remembers 3Hotdogs 17 hrs ago #1
"O.t.o h., who remembers a drug called Thalidomide." BumRushDaShow 16 hrs ago #3
Yes, Icanthinkformyself 16 hrs ago #2
IIRC, he's a doctor (MD) Jilly_in_VA 14 hrs ago #4

3Hotdogs

(15,185 posts)
1. Mixed feelings- one one hand, we want new or improved drugs to reach our medicine cabinets. O.t.o h., who remembers
Wed Feb 18, 2026, 08:18 AM
17 hrs ago

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

(167,657 posts)
3. "O.t.o h., who remembers a drug called Thalidomide."
Wed Feb 18, 2026, 08:57 AM
16 hrs ago

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.

Jilly_in_VA

(14,165 posts)
4. IIRC, he's a doctor (MD)
Wed Feb 18, 2026, 10:53 AM
14 hrs ago

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.

Latest Discussions»Latest Breaking News»Top Republican eyeing FDA...