PEAK TESTOSTERONE

Congress Fights for Compounding Pharmacies Against the FDA and Big Pharma

According to a recent Peak Testosterone Forum poll, about 70% of our men on TRT (testosterone therapy) are using either compounded injectible testosterone or compounded HCG. [1] I know that we have a couple of guys using compounded creams as well. And the percentage of women using compounded hormonal creams would likely be even higher still. Basically, compounded products offer incredible value and customization for those on TRT or HRT and they in HOT demand. There are competing brand name Big Pharma products, but they are ridiculously expensive and, in the case of women's hormones, are nasty synthetics that almost no one wants.

As expected, Big Pharma, working through the FDA, has come after the compounding pharmacies with a vengeance in the last couple of years and are doing all they can to crush the compounding industry into oblivion, or at best abject servitude. 

The latest strongarming comes from the following set of FDA regulations and letters:

  • Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
  • Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
  • FDA issues proposals to implement statutory restrictions on compounding drugs that are essentially copies of commercially available or approved drugs
  • So what is the purpose of all this bureaucratic regulation?  When it comes to hormones, there is NO purpose in this.  Compounders have been doing injectible and transdermal testosterones and hormones for decades.  And they were doing it BEFORE Big Pharma even got involved.  It is actually Big Pharma that copied the compounders, and now they are ironically trying to murder their own mother.

    How are they planning on doing this?  Well, the above documents clearly define what an "essential copy" is: the FDA intends to consider a compounded drug product to be identical or nearly identical to an approved drug if the compounded drug product and the FDA-approved drug have the same:

  • active ingredient(s),
  • route of administration,
  • dosage form,
  • dosage strength, and
  • excipients.
  • Now compounders can actually bypass - kind of - the above regulation by simply tweaking any one of these.  However, the above regulations attempt to close even this through lines 264-377. Those lines state that anything a compounder makes that is already a component of a FDA approved drug is automatically considered an essential copy - period!

    Guess what this does?  It eliminates virtually ALL compounded hormones!  Compounders would literally be violating the law if they provide compounded testosterone or other hormones as they do now.  Yes, that means bye bye compounded hormonal products and say hello to another Big Pharma monopoly.

    Well, almost.  Actually, the FDA was not quite that inflammatory.  They left a loophole in the above that states that an exception can be made if the doctor provides a justication with the prescription.  What this means is that EVERY single prescription order has to state a justification to why the prescriber is using that drug and the clinical difference it produces versus using a commercially available drug.  This is a huge hassle for doctors and a completely unnecessary one.  Seriously, why can't your doctor order a testosterone and HCG as he sees fit?  Why does the FDA have the right, for example, to force you and your insurance to pay for a $350 monthly supply of Androgel (that often doesn't work well) when he could order a $50 container of compounded testosterone cream with a greater strength and better deliver system?! 

    While this may not kill compounding, the clear purpose is to lower sales in the short term by putting unnecessary red tape for doctors.  And they have the language in place to completely hang the compounders at a future date if they want to.  (Some of the other regulation could actually kill compounding as we know it - more on that later.)

    WHAT CAN YOU DO?  If you don't want to see your compounded testosterone and HCG go away, then I encourage you to do something about this needless regulation as soon as possible.  Remember also to tell your wife or girlfriend if appropriate if you do not want to see her forced onto synthetic hormones.  Below are three ways to fight this before it is too late:

    1. Contact Your Senator or Congressman.  Fortunately, some lawmakers are beginning to push back.  For example,  "Representative Chris Stewart (R-UT) and Henry Cuellar (D-TX) letter to FDA regarding the preservation of office use compounding has been sent with 61 CONGRESSIONAL SIGNATURES!"  The momentum is just now starting to gather and so it is critical you act now.  61 congressmen is a great start, but, of course represents a small minority of states. [2] Your call make a difference.

    2. Send a Letter to the FDA.  The FDA receives around $600 million dollars per year from drug companies.  This policy is, quite simply, legalized corruption.  Nevertheless, they will often listen to well-written and professional letters from the general public.  Nelson Vergel has a link here to the FDA and the actual letter that he sent as guidance.  Remember:  you have to be professional and use sound logic to support your position or it will not be considered.

    3. Spread the Word. Get others involved and have them read this page and do #1 and #2. Again, it can really make a difference. 

    NEWS FLASH:  The only pharmacist member of Congress (Rep. Buddy Carter (R-GA), BSPharm) made an impassioned speech against all of this in early May.