FDA needs to be trimmed back hard
Every metastasizing cancer cell in the Federal Government - which is every cell - grows without stop unless blasted with (political) radiation, chemo or the surgeon's knife.
Another day, another unaccountable Federal bureaucracy far outstripping its legislative mandate, to seize more and more control over the American people. Today’s Abuse of Power comes from the Food & Drug Administration.
Not content with stifling innovation in medical devices and drugs - unless of course you have the deep pockets of Pfizer to scatter cash and tropical vacations to everyone in the Beltway - the FDA has now decided to impose massive costs and arbitrary hurdles on scientific testing laboratories who are just doing their jobs.
I call attention because the Administrative Leviathan thrives upon important nuggets of real news being drowned out by a never-ending cacophony of 9-second clips of nubile young women wiggling synchronously on BikNot or whatever the hell the Chinese Communist spy tool is called.
Joel Zinberg1 wrote a great piece for the National Review about this power grab.
Laboratory Developed Tests (LDTs) are just what they sound like - tests trained scientists use while doing their jobs. They are not products sold to others to use; LDTs are to chemistry, say, what Python models are to data science - basic tools used by professionals to look for potential results.
The Federal Food, Drug, and Cosmetic Act (FDCA) gives the FDA broad authority to regulate medical devices “intended for use in the diagnosis of disease.” The agency mandates a pre-market review of diagnostic test kits manufactured by one entity and sold for use elsewhere.
The FDA has also asserted for at least 30 years that this includes the authority to regulate LDTs — tests that are designed, manufactured, and used within a single laboratory — as devices. Many academic and public-health labs, for example, developed tests for rare genetic conditions seen in their patient populations, cancer markers, and emerging infectious diseases such as HIV when no other tests were available.
But until recently, the FDA, citing “enforcement discretion,” has rarely regulated LDTs. LDTs have instead been regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), under which laboratories that are certified to perform high-complexity testing — the highest of three levels of complexity under CLIA — may develop and use LDTs.
LDTs are performed billions of times a year in approximately 12,000 CLIA certified high-complexity laboratories and generate billions of dollars in revenue. Exempting LDTs from FDA oversight gives specialized labs flexibility to rapidly create new tests for rare diseases and emergent situations.
Despite the FDA’s claims to the contrary, there is little evidence that LDTs are less reliable or accurate than FDA-approved tests. And awaiting the FDA’s review and clearance of new tests can delay critical testing with disastrous results.2
The first major hurdle - which in a normal society would be dispositive - is that the law creating the FDA says nothing about the agency being able to regulate intellectual property which is used for purposes internal to one laboratory. The LDTs by definition are not products developed for sale to others. Lest we shrug off that pesky detail of legality - which every Federal agency does on the daily - this new intrusiveness will in no way improve safety of testing efficacy.
For added fun, the insane costs this would impose would decrease competition in the testing space. I cannot write this better than Joel Zinberg already has in his National Review piece, so I quote him again here:
Laboratories have openly developed LDTs that physicians used to diagnose and treat large numbers of patients for nearly 50 years. Yet the FDA has almost never regulated LDTs. As the Supreme Court noted in 2014, “when an agency claims to discover in a long-extant statute an unheralded power to regulate ‘a significant portion of the American economy,’ we typically greet its announcement with a measure of skepticism.” Congress has repeatedly proposed, but never passed, legislation which would explicitly empower the FDA to regulate LDTs, suggesting Congress doubts the FDA’s authority under the FDCA.
Moreover, it is unlikely that the FDA has the capacity to clear the thousands of existing LDTs along with reviewing new LDTs. The U.S. Government Accountability Office (GAO) found that laboratories had great difficulty navigating FDA’s EUA requirements during the pandemic, and the FDA was overwhelmed. GAO reported that almost two years into the pandemic, the FDA had not reviewed nearly half of the EUA test requests it received. The review procedures called for in the proposed FDA rule are more extensive than the expedited EUA reviews that the FDA had so much trouble carrying out.
The FDA acknowledges that its rule will impose significant compliance costs on laboratories that offer LDTs — $35.5 billion over the multi-year phase-in and additional recurring costs of $4.2 billion — leading some laboratories to exit the market or discontinue certain LDTs they offer. Ninety percent of the laboratories offering LDTs are small businesses. The new rule would impose annualized costs per small laboratory that are 22.9 percent of receipts, which, the FDA admits, will cause many to “exit the market or reduce operations.” If the prospect of a lengthy and costly FDA process discourages labs from creating innovative new tests or tweaking FDA-approved tests to make them better, patients will lose access to valuable tests for unmet clinical needs or where FDA-approved tests are inadequate.
Billions of dollars of deadweight drag on the economy - ALL of which plus a margin will be passed along to consumers in one way or another - all to “‘solve” a non-existent “problem” that has never appeared before.
These clowns depend upon widespread apathy in the taxpaying citizenry. Get involved. Start here and send your Congressional Representatives, your Senators and the White House a brief note saying, “Don’t let the FDA further bankrupt the nation with their illegal attempt to regulate LDTs.”
In 90% of cases, you’ll make a staffer go find out what the hell an LDT is in the first place.
The bureaucracy wants to kill the nation with a million papercuts. Don’t let them. Demand your representatives slap back the FDA in its latest attempt to grow uncontrollably.
Joel Zinberg is a senior fellow at the Competitive Enterprise Institute and the director of the Paragon Health Institute’s Public Health and American Well-Being Initiative. He served as senior economist at the White House Council of Economic Advisers, 2017–19.
FDA, facilitating chronic illness in the 21st Century!