F.D.A. Panel Backs Limits on Testosterone Drugs but Rejects Petition for More Regulations

This will probably affect insurance coverage for TRT. This meeting was held at the FDA on September 17, 2014 and did not include patients testimonials.

FDA panel recommends scaling back testosterone use in men, citing little evidence of benefit

This is a push-back effort that originated from excessive pharmaceutical ads and claims. The two misleading and flawed studies did not help either!

These comments are definitely going against current data on testosterone replacement. Yes, we need longer term studies (the longest to date is 5 years long), but there is a definite bias in these statements:

" Federal health experts said Wednesday there is little evidence that testosterone-boosting drugs are effective for treating common signs of aging in men and that their use should be narrowed to exclude millions of Americans currently taking them.

The panel of Food and Drug Administration advisers voted 20-1 that prescribing language on blockbuster testosterone treatments should be revised to make clear they have not been shown to reverse common aging issues like low libido, fatigue and muscle loss. The labeling change would drastically limit the drugs' FDA-approved indication to men who have abnormally low hormone levels due to disease or injury, instead of aging."

Comments anyone?

Testosterone and libido studies: Click here

Testosterone and muscle mass: Click here

Testosterone and fatigue: Click here

The FDA has always been very conservative in its opinions.

Yes, as you stated Nelson, this will affect big insurance formulary drug approval policies but for those men who pay directly for their HRT for anti aging purposes this will have no real effect.

Nothing here I didn't expect to be honest but the fact that there were no patient testimonials is rather shocking.

FDA and testosterone

This is one of the few times we can hope that the drug companies have lobbies more powerful than the insurance companies in order to change this direction and flawed belief system. I normally wouldn't wish that kind of power to the drug T anufacturers but in this case we need as much push as we can get. I for one know how beneficial TRT has been for me....but if the FDA did not even include outside commentary, how likely are they to listen to petitions?

It is a shame for those who rely on insurance. But, for me, I noticed that when I went from once a week to every other week, a marked muscle loss and lowered libido occurred. So, it contradicts what they concluded; and, it is a shame they didn't entertain patient testimonials.

This is insane. So do I call my Endo and ins or just wait? Fortunately I have like 5 months worth of T left. Will this limit access to Arimidex also?

CoogPaw said:

It is a shame for those who rely on insurance. But, for me, I noticed that when I went from once a week to every other week, a marked muscle loss and lowered libido occurred. So, it contradicts what they concluded; and, it is a shame they didn't entertain patient testimonials.

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OT, but you know why every two week injections is all wrong...right???

If you are paying for HRT you will still get it:

"Even as experts recommended narrower use of the drugs, they acknowledged it will be difficult to change physician prescribing habits".

Limiting Testosterone

Nelson Vergel said:

Testosterone and libido studies: Click here

Testosterone and muscle mass: Click here

Testosterone and fatigue: Click here

Click to expand...

Hi guys. I think the issue is not well understood how FDA regulate drugs.
There are two main problems that worry the regulators on the issue of the enormous up use of testosterone and some data claiming bad outcome on patient.
Making claims by the pharma industry which were not backed by data submitted reviewed and approved by FDA.
The other basic issue in medicine and drugs is that a medical treatment should be for a defined medical state, illness and “make no harm” to patients. Aging and antiaging are not defined as medical condition or illness. It is defined as natural course of life. Industry never proved by clinical studies that giving male testosterone made any man younger or elongated male life.
3. The existence of scientific doubt, though may be bad science, raise the issue of “may harm” to patients and drug adulteration and is enough to make the regulator, FDA , worry and try to block illegal use, abuse of drug and request industry to perform clinical studies and submit data on the issue raised e.g. cradiological issue.
You can read for instance what is the regulatory state of Depo-Testosterone T-Cyp and understand what kind of data submitted to FDA on that product and for which indications industry submitted data on efficacy and safety for the product. You will see that FDA have not been requested to review data on benefit of aging male. http://www.drugs.com/pro/depo-testosterone.html
You can read for instance what is the regulatory state of AndroGel at http://www.drugs.com/pro/androgel.html
For instance the state of data submitted by abbvie in support of Geriatric Use is :
“There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing AndroGel 1% to determine whether efficacy in those over 65 years of age differs from younger subjects. Additionally, there is insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer.
Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH”.
So by advertising AndroGel, abbvie was violating drug laws claiming or suggesting adulteration and false claims and cheating consumer according to the law. FDA forced abbvie to stop those false advertisement.
It does not mean that there are no scientific data that Testosterone is involved in libido, muscle mass or fatigue. It just means that AndroGel or any other T product cannot be sold as drug for those unproved and unapproved indications as law require. And as T products are defined by law as drug, FDA by law has to control sale.
It is another issue of the insurance, if the drug is not authorised for an illness of course the insurance will refuse financing, except for the approved indications .
It may be now a challenge for industry to decide whether they wish to finance and back the claims with clinical trials that cost so and so in order to have the ability to add these claims to the label . Not us the patients nor FDA can put the money and effort to generate the data . It is going to be an interesting game to follow what FDA -industry-and medical bodies will act in the mater. May be we the patients are going to lose an important treatment .

Gene Devine said:

OT, but you know why every two week injections is all wrong...right???

Click to expand...

Correct me if I am wrong but I believe it's because of half lives right? Given that E or C have a half life of about
a week... for some reason I thought it was higher . Actually double checked my facts.

HarryCat said:

This will probably affect insurance coverage for TRT. This meeting was held at the FDA on September 17, 2014 and did not include patients testimonials.

FDA panel recommends scaling back testosterone use in men, citing little evidence of benefit

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some more aspects about the recommendation vote
"FDA Advisory Panel Urges Restrictions on Testosterone Use"
http://www.medscape.com/viewarticle/831897?src=wnl_edit_tpal

Why is it I keep comparing this "expert"panel's findings to the place statin drugs have found in the marketplace?

Eli1947 said:

It may be now a challenge for industry to decide whether they wish to finance and back the claims with clinical trials that cost so and so in order to have the ability to add these claims to the label . Not us the patients nor FDA can put the money and effort to generate the data . It is going to be an interesting game to follow what FDA -industry-and medical bodies will act in the mater. May be we the patients are going to lose an important treatment .

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Great post, Eli1947

The FDA just posted the briefing of the meeting. I am reading it this weekend.


Here it is: http://www.fda.gov/downloads/Adviso...iveHealthDrugsAdvisoryCommittee/UCM412536.pdf

Right after this meeting...

The FDA wants more safety data and declined approving oral testosterone undecanoate, a drug that has been used for years in Canada as Andriol (you have to take it at least twice per day).

"The panel also ruled 17-4 that the overall profile for benefits and risks of the soft-gel capsule formulation oral testosterone undecanoate (TU) Rextoro, developed by Clarus Therapeutics, did not support approval of this product for testosterone replacement therapy."

FDA committees withhold approval of oral testosterone therapy

The era of easy testosterone product approval is over.

Nelson, what do you think this will mean for Androxal approval that was to occur in 2015 after they finished their Phase III trials this year? Repros claims that Androxal is not what the FDA is targeting, since it is supposedly for men who have low T from being overweight. Hmmm, that's who they do their trials with, but there are lots of us who are just fine in the weight dept., respond well to clomiphene (except for SHBG increase and libido loss) and would be good candidates for Androxal. Just when I thought we were almost there.........

NinjaRyder said:

Correct me if I am wrong but I believe it's because of half lives right? Given that E or C have a half life of about
a week... for some reason I thought it was higher . Actually double checked my facts.

Click to expand...

This is OT for this thread:

Test E and C peak serum levels at about 72 hours after injection with a half life about about 6 days for most men - and not a week.

It's why weekly injections are the standard protocol with twice weekly even better for more stable serum levels and better E2 control.

txmx

This is what I read yesterday on the Wall Street Journal:

"[h=5]September 22, 2014 10:14 AM[/b]Repros Therapeutics Says FDA Recommendation Not Directly Applicable to Androxal[h=2]Biopharmaceutical Drug Developer Says Androxal Isn't a Form of Testosterone[/b]By Tess Stynes
[h=2]FDA Recommendation Doesn't Apply to Androxal, Repros Says[/b]Repros Therapeutics said a Food and Drug Administration advisory panel recommendation doesn't directly apply to its lead drug candidate to treat low testosterone caused by secondary hypogonadism."

What will this mean in regard to the scheduled approval process for Androxal? Any delay or denial because of this ruling? More trials required?