I am bumping this to remind readers that the comment period for this FDA action ends on Feb. 9 and to encourage others, particularly men with direct experience with TRT, to submit comments through the link above. I think it really makes a difference: remember the 40 thousand or so comments submitted in response to the DEA move to tighten telemedicine prescribing and how that is what probably held off actions that would have affected all of us adversely? I really think these comments, and the large number of them, really make a difference.
I have been following the comments submitted so far, and it seems that a very large percentage of them are being made by women. Don't get me wrong: these comments are welcome and critically important and should be considered every bit as carefully as those by men. However, since the request for public comment is specifically requesting input pertaining to the recent expert panel on TRT for men, I believe that it could only help to have as many comments from men, in addition to those from women, as we can possibly post before the Feb. 9 deadline.
My personal interest in this matter is most acute in the proposal to remove testosterone as a controlled substance. I believe this would be an incredible advance in our shared quest toward educating as many men as we can about the potentially life-changing benefits of TRT. To that end, I am sharing below the comment I wrote and submitted earlier today. Please feel free to adapt or use any part of it that you wish:
Comment:
I am writing to advocate strongly for the descheduling of testosterone as a DEA-controlled substance, as advocated by members of the recent FDA Expert Panel on Testosterone Replacement Therapy for Men (Docket FDA-2025-N-6743). I have been on a testosterone replacement protocol for nearly 15 years and can attest both to its life-changing benefits as well as to the lack of side effects. Testosterone is a naturally occurring hormone for both men and women. When properly dosed and monitored by well-informed medical providers, testosterone therapy effectively addresses not only symptoms associated with the aging process but also addresses other serious conditions that affect men and women of any age, among them major depression, loss of libido, and cardiovascular/metabolic syndromes. In my own case, supplementing natural testosterone production with a modest exogenous dose has allowed me to cast off the many antidepressants I was prescribed in a desperate attempt to find relief from the symptoms of endogenous depression I had felt for most of my life.
It is important to remember the history that led to testosterone being scheduled as a controlled substance. I very clearly remember the athlete doping scandals of the 1980s and the subsequent congressional “pearl-clutching” that resulted in this action. I also clearly remember that the DEA and other concerned parties were opposed to the inclusion of testosterone in schedule 3 because this naturally occurring substance was not a drug with a high potential for abuse. In fact, history has also shown that the small number of people abusing testosterone are quite capable of accessing it through underground channels, with the net result being no change in the prevalence of doping in athletics and elsewhere. In other words, scheduling testosterone as a controlled substance did nothing to solve the perceived problem. Instead, this poorly thought-out action simply made it more difficult for those of us with a legitimate medical need to access a life-changing therapy. As stated by the Sexual Medicine Society of North America and other professional organizations, “De-scheduling will streamline access to this beneficial therapy by improved
pharmacy access, relaxation of prohibitions against interstate prescribing, and reduced
authorization burdens for insurance carriers; de-scheduling will also reduce the stigma many men seeking this treatment may feel and will facilitate the education of health care providers and the public on safe prescribing practices.” My own experience backs up those assertions fully.
I am grateful that the FDA has opened its mind to considering formally what many of us have known to be true for a long time: that testosterone is not a drug to be feared or regulated out of existence but rather is a completely natural part of the human condition. When properly managed and used, its benefits can be life-changing. Thank you in advance for taking these important first steps toward removing testosterone as a controlled substance.
