FDA Moves to Regulate Single-Lab Tests

[joshualevy]

This article describes a recent FDA attempt to regulate diagnostic tests run by a single lab.
Right now, those tests can be marketed before they are validated, as we saw in the XMRV fiasco.

http://www.nytimes.com/2014/08/01/business/fda-to-regulate-lab-developed-test-kits.html?_r=0

Joshua (not Jay) Levy

 

[Ren]

I just posted about this article elsewhere, with the Lyme (borrelia) angle having caught my attention...

"F.D.A. Moves to Regulate Lab-Developed Tests"

"...The decision, long in coming, has been fiercely opposed by some laboratories and pathologists, who say that regulation by the agency is unnecessary and would significantly increase the cost and time needed to develop tests, stifling innovation and depriving patients of some vital tools...

Test systems or kits that are sold to hospitals, laboratories, doctor’s offices and the public have long been regulated as medical devices, giving the agency the opportunity to review them before they are marketed. But tests developed and performed by a single laboratory, with all samples being sent to that laboratory, have typically not been. The F.D.A. had claimed the legal authority to regulate these so-called laboratory-developed tests, but said it was exercising “enforcement discretion” not to do so.

The agency said Thursday that the discretion must now end because circumstances had changed...

The F.D.A. first proposed regulating certain lab-developed tests in 2006. It held two days of public hearings on the issue in 2010.

But its efforts so far have run into fierce opposition. The agency’s draft guidance on how it would regulate these tests has apparently been locked up, ostensibly under review, by the White House Office of Management and Budget.

Five Democratic senators who favor F.D.A. regulation, led by Edward J. Markey of Massachusetts, wrote to the budget office on July 2, demanding that it release the draft guidance...

But with some Republican opposition to such regulation, Congress enacted a requirement that it be notified 60 days in advance of the publication of the draft guidance. Presumably this would allow time for efforts to stop publication.

The F.D.A. fulfilled that obligation on Thursday, notifying Congress that the draft guidance would be published in 60 days, after which it would be open for public comment. In so doing, the agency provided a preview of what the guidance would say.

Those who support the agency’s move to oversee lab-developed tests say such tests can play pivotal roles in determining whether someone is ill or what treatment to provide, so an errant result can be harmful. The Centers for Disease Control and Prevention, for instance, recently warned about false readings from a laboratory-developed test for Lyme disease.

But laboratories, pathologists and some testing companies say the need to obtain F.D.A. approval would stifle innovation...

The labs also dispute that the agency even has jurisdiction. They say that testing is a service, not a medical device. It is unclear yet whether certain laboratory trade groups might now go to court seeking a ruling that the agency has no jurisdiction over lab-developed tests...

FULL ARTICLE: http://www.nytimes.com/2014/08/01/business/fda-to-regulate-lab-developed-test-kits.html

 

[taniaaust1]

It was just bad luck over the XMRV thing, I personally dont like the idea of everything coming under FDA regulation esp when governments often just dont do the right thing. It may stop good new tests from being put out.

 

[Waverunner]

I would abolish the FDA rather today, than tomorrow. The FDA blocked more innovation and cost more lives, than any other government institution except the military. What the FDA does is, it blocks scientists from entering the market and prevents competition to happen in the pharma field. It costs around 1 billion to get a drug approved and it takes 12-15 years. This is insanity at its finest. You have patients dying all over the world because working treatments are lacking. Even patients who die within 1 week are not allowed to try non approved drugs. In the first half of the 19th century it took 180 days, till the FDA approved a drug, now it takes 12-15 years.

I have no problem when the FDA controls fraud or safety but there is no reason, that scientists all over the world have to come begging to the FDA in order for their drugs to get approved. If we as patients are not sure about the safety of experimental non-FDA approved drugs, we shouldn't take them. But if the FDA requires all scientists to run through their absolutely retarded and innovation hostile approval process, this is just crazy. It kills much more lives, than it prevents and it prevents the patient from taking care of his own health, but this is what the FDA wants.

Regarding XMRV, were the tests fraud? Yes? Sue them! No? Mind your own business, bad luck for you (and me because I ordered one).

 

[*GG*]

I would abolish the FDA rather today, than tomorrow. The FDA blocked more innovation and cost more lives, than any other government institution except the military. What the FDA does is, it blocks scientists from entering the market and prevents competition to happen in the pharma field. It costs around 1 billion to get a drug approved and it takes 12-15 years. This is insanity at its finest. You have patients dying all over the world because working treatments are lacking. Even patients who die within 1 week are not allowed to try non approved drugs. In the first half of the 19th century it took 180 days, till the FDA approved a drug, now it takes 12-15 years.

I have no problem when the FDA controls fraud or safety but there is no reason, that scientists all over the world have to come begging to the FDA in order for their drugs to get approved. If we as patients are not sure about the safety of experimental non-FDA approved drugs, we shouldn't take them. But if the FDA requires all scientists to run through their absolutely retarded and innovation hostile approval process, this is just crazy. It kills much more lives, than it prevents and it prevents the patient from taking care of his own health, but this is what the FDA wants.

Regarding XMRV, were the tests fraud? Yes? Sue them! No? Mind your own business, bad luck for you (and me because I ordered one).

I think Life Extension magazine thinks that the FDA at least needs some major revisions! I very much agree with you and them, problem with bureaucracies is that they continue to grow, and that makes them less efficient and cost effective!

Their budgets grow, money is power, good luck downsizine them! Perhaps the next financial crash will help that happen? And many more useless US gov't bureaucracies, most of this spending is just unsustainable!

GG

 

[Waverunner]

I think Life Extension magazine thinks that the FDA at least needs some major revisions! I very much agree with you and them, problem with bureaucracies is that they continue to grow, and that makes them less efficient and cost effective!

Their budgets grow, money is power, good luck downsizine them! Perhaps the next financial crash will help that happen? And many more useless US gov't bureaucracies, most of this spending is just unsustainable!

GG

I fully agree. Government institutions never give away powers on their own. They keep growing and either the system collapses or they are forced to change their behaviour by outside forces.

The only solution I see for this whole dilemma is gene therapy. Gene therapy works by replacing faulty genes or silencing them. The good thing is, that the process for delivering gene therapy is always the same, no matter if you want to treat cancer or diabetes or other diseases. You have to target other parts of the genome but you always use the same delivery vehicle, just with another destination. Like a plane. A plane can be used to travel around the world, it is not bound to flying to the same target all the time. So humanities aim should be to find a plane, which is effective and safe. Maybe CRISPR is such a plane and we already found it, who knows.

The next thing is to map the genes and find the destinations. GWAS deliver new destinations and confirm old destinations nearly on a daily basis. We get better and better at finding the disease specific hot spots in our genome.

And the final thing will be to use gene therapy in the clinical practice. Imagine a world where diseases can be cured at the molecular level, where they start at. No more drugs, which have to be taken daily for the rest of ones life. Trillions of dollars could be saved. Imagine the huge boost for the economy, when there are nearly no more chronic diseases. The FDA is slowing down gene therapy tremendously in the US but when gene therapy becomes available in Singapore, Switzerland or China, who cares about the FDA? The FDA is out of the picture then.

 

[joshualevy]

I have no problem when the FDA controls fraud or safety but there is no reason, that scientists all over the world have to come begging to the FDA in order for their drugs to get approved.

I think these two phrases are in direct contradiction to each other. The way FDA controls fraud and safety is by making treatments come to the FDA to get approved. You can't have one without the other.

Regarding XMRV, were the tests fraud? Yes? Sue them! No? Mind your own business, bad luck for you (and me because I ordered one).

That is even more libertarian that most libertarians would accept (They think personal lawsuits are the way to prevent fraud, instead of government regulation.) For my part, I think this attitude gives fraudsters a big advantage, because they can lie to everyone at once, but the lawsuits to prevent this fraud are filed one person at a time.....

Joshua (not Jay) Levy

 

[Waverunner]

I think these two phrases are in direct contradiction to each other. The way FDA controls fraud and safety is by making treatments come to the FDA to get approved. You can't have one without the other.

No, they are not in contradiction to each other . Please read my words again. I didn't say, that the FDA should approve drugs before they enter the market (which would be OK for me, if the cost is reasonable and it takes no more than one year to get the requirements done). What I did say was, that the FDA should control fraud and safety. If you sell a drug and claim that it cures cancer, while it does nothing, the FDA should sue the hell out of you. And if you sell a drug and it turns out, that more and more people die from it because manufacturing is flawed or there are some high risk patients, the FDA should investigate. But if a scientist sells a new monoclonal antibody called XYmab and makes no claims whatsoever, except "This is XYmab and it acts on XY and it can be taken by humans." I don't see any problem. Nobody is forced to buy it and as long as the scientist makes no false claims, I have no problem with it and the FDA shouldn't have either.

"Regarding XMRV, were the tests fraud? Yes? Sue them! No? Mind your own business, bad luck for you (and me because I ordered one)." That is even more libertarian that most libertarians would accept (They think personal lawsuits are the way to prevent fraud, instead of government regulation.) For my part, I think this attitude gives fraudsters a big advantage, because they can lie to everyone at once, but the lawsuits to prevent this fraud are filed one person at a time.....

Joshua (not Jay) Levy

I highly doubt that you know, what libertarianism is, because my position is a paragon for how a libertarian system would look like. Suppose you sell a non-working XMRV test and others buy it. Unfortunately you make the claim, that it is a working XMRV test and others start suing you. While it is true, that you lied to many people at once, it doesn't prevent you from either paying indemnity and/or going to jail. In the end, no matter how you put it, the fraudster will be left holding the bag.

The current system not only inhibits innovation but it also doesn't prevent fraud. You can buy whatever you want on the internet. Illegal drugs from India, Mexico, Canada. What you can't buy are innovative, good working new drugs because the people who are able to invent them are not willing to go to jail and have no criminal energy and can't spend 1 billion dollars and 10 to 15 years.

 

[Ren]

For those inclined to write to their (US) elected representatives and/or FDA, here's a bit more info regarding specific players:


The following US Senators have signed a letter in support of FDA control of testing (particularly FDA control of Lyme disease testing):

Sen. Blumenthal (D-CT)

Sen. Edward Markey (D-MA)

Sen. Elizabeth Warren (D-MA)

Sen. Sherrod Brown (D-OH)

Sen. Richard Durbin (D-IL)

http://www.markey.senate.gov/imo/media/doc/2014-07-02_Deese_LDTs.pdf

(FYI, FDA commissioner = Dr. Margaret A. Hamburg)



The public comment period for the proposed [FDA] regulation will open in October.

Those critical of the move for FDA control, include:

the Lyme community, including Lyme physicians

the American Medical Association

the Association for Molecular Pathology

the American Clinical Laboratory Association (ACLA)

and at least twenty-three laboratory directors and pathologists from academic centers including Harvard, Duke, and the University of Utah.

http://lymedisease.org/news/lymepolicywonk/fda-and-lyme-tests-is-it-simply-vested-interests-protecting-vested-interests.html?utm_source=FDA+and+Lyme+testing&utm_campaign=FDA+%26+other+Aug+news&utm_medium=email#sthash.0v2eIlln.dpuf

http://www.acla.com/wp-content/uploads/2014/07/Letter-to-OMB-from-Lab-Leaders.pdf


“The issue has also become the subject of jockeying in Congress, with some Democrats pushing for F.D.A. regulation and some Republicans trying to head it off… at the urging of Representative Michael C. Burgess, a Texas Republican opposed to F.D.A. regulation of lab-developed tests, Congress required the agency to notify it 60 days before the publication of the draft guidance.

The F.D.A. fulfilled that obligation on Thursday, notifying Congress that the draft guidance would be published in 60 days, after which it would be open for public comment.

Mr. Burgess criticized the agency’s move in a statement on Thursday, though he did not say if he would do anything to try to prevent publication. Perhaps not coincidentally, the F.D.A. notification came just before Congress was to begin a five-week recess, eating up the clock…”

http://www.nytimes.com/2014/08/01/business/fda-to-regulate-lab-developed-test-kits.html?_r=0