FDA expert panel TRT 12/10/25

[yungbig]

Watch on YouTube or this link

FDA Expert Panel on Testosterone Replacement Therapy for Men

FDA Expert Panel on Testosterone Replacement Therapy for Men

www.fda.gov

Seems like a reclassification of testosterone is on the horizon. Potentially making legal pharma grade a lot easier and cheaper to get. (Not that it's really hard to get in the US)

 

[PiscesMoon]

Watch on YouTube or this link

FDA Expert Panel on Testosterone Replacement Therapy for Men

FDA Expert Panel on Testosterone Replacement Therapy for Men

www.fda.gov

Seems like a reclassification of testosterone is on the horizon. Potentially making legal pharma grade a lot easier and cheaper to get. (Not that it's really hard to get in the US)

Thank you for sharing this

 

[newguy2]

Here is an outline of the transcript.

Bold Outline of the Transcript


1. Opening: From Women’s HRT to Men’s Testosterone Health

• FDA leadership explains that they recently corrected long‑standing dogma around women’s hormone replacement therapy and are now turning attention to men’s testosterone therapy and health.
• 
  
• They emphasize that evidence linking testosterone to prostate cancer and cardiovascular risk has been overstated or misinterpreted, and that current data require a fresh, evidence‑based reassessment.

2. Burden of Low Testosterone and Why It’s Undervalued

• Large proportions of men have low testosterone (e.g., >1/3 of men over 45 <300 ng/dL; ~5.6% of men 30–79 with low T + symptoms), yet the topic is taboo, under‑discussed, and under‑treated.
• 
  
• Symptoms include reduced vitality, strength, libido, mood and mental health issues, with low testosterone strongly associated with cardiovascular disease, fractures, diabetes, obesity, depression, infertility, and increased all‑cause mortality.

3. Core Message: Testosterone Is a Health Hormone, Not a Lifestyle Drug

• Multiple experts stress that testosterone therapy is not a “lifestyle” or cosmetic drug but a cornerstone of preventive health that restores normal physiology and reduces risk for chronic disease.
• 
  
• Low testosterone is framed as a powerful biomarker of poor men’s health and early death, deserving routine screening alongside cholesterol and glucose, particularly in men with metabolic disease or depression.

4. Safety Data: TRAVERSE and Other Major Trials

• The TRAVERSE trial (5,246 hypogonadal men, high CV risk) found testosterone did not increase heart attack, stroke, prostate cancer, or lower urinary tract symptoms, and led the FDA (Feb 28, 2025) to remove the cardiovascular black‑box warning.
• 
  
• Other RCTs (T4DM, Basaria study, T‑Trials) show:
  
  • No increase in major adverse cardiovascular events with physiologic TRT.
• 
  
• Significant reductions in diabetes incidence/progression and improvements in sexual function, mood, anemia, bone mineral density.

5. Prostate Cancer Dogma Is Outdated

• Historic belief that testosterone “feeds” prostate cancer came from extremely weak early data (Huggins, essentially one patient over 18 days), yet drove a 60‑year global prohibition.
• 
  
• Modern evidence (large biopsy‑based cohorts, RCTs including TRAVERSE, meta‑analyses, observational data) shows:
  
  • Endogenous higher testosterone does not increase prostate cancer risk.
• 
  
• TRT does not raise prostate cancer incidence; some large datasets suggest reduced risk.
• 
  
• Even in men with treated or metastatic prostate cancer, published series have not shown higher recurrence or progression on carefully monitored TRT.
• Panelists argue current label contraindications and warnings about prostate risk are scientifically obsolete and should be removed.

6. Regulatory Misalignment and Barriers to Care

• FDA labels restrict TRT to specific “classical” causes (testicular or pituitary disease) and exclude age‑related or comorbidity‑related hypogonadism, while professional guidelines (AUA, Endocrine Society) recommend treating symptomatic men with low T regardless of cause.
• 
  
• This mismatch creates confusion, fear of prescribing, and leaves large numbers of symptomatic men untreated despite evidence that low T itself (not the etiology) drives risk for obesity, sarcopenia, bone loss, MACE, and high‑grade prostate cancer.

7. Scheduling and Stigma: Case for Descheduling Testosterone

• Testosterone was placed in Schedule III in 1990 for political/anti‑doping reasons, not based on dependency or public health data.
• 
  
• There is no evidence of dependence at physiologic doses; testosterone is scheduled more strictly than many drugs with real abuse potential, while other endogenous hormones (estrogen, progesterone, thyroid, cortisol, hCG) are not scheduled.
• 
  
• Schedule III status:
  
  • Discourages legitimate prescribing and screening, drives patients to pop‑up T‑clinics or illicit sources, and amplifies stigma at pharmacies and in state monitoring programs.
• Recommendation: remove physiologic testosterone from DEA scheduling (keep synthetic anabolic steroids scheduled) using the existing Controlled Substances Act mechanisms.

8. Screening, Indications, and Individualization

• Experts advocate:
  
  • Broader screening, especially for men with metabolic disease, obesity, diabetes, osteoporosis, depression, or early frailty.
• 
  
• Treating men with both symptoms and confirmed low testosterone, including those with “age‑related” hypogonadism.
• Emphasis on free testosterone: due to SHBG variation, men can have “normal” total T but low free T and clear symptoms; data show symptoms track free T, so decisions must be individualized, not strictly lab‑number based.

9. Cardiometabolic and Bone Health Implications

• Low testosterone and metabolic syndrome/diabetes have a bidirectional relationship; each worsens the other and increases mortality.
• 
  
• TRT plus lifestyle modification significantly reduces diabetes development and improves glycemic control compared with lifestyle alone.
• 
  
• In bone health:
  
  • Up to one in four men over 50 develop osteoporosis; hip fractures in men carry ~31% one‑year mortality and are strongly associated with low T.
• 
  
• TRT improves bone mineral density in hypogonadal men and should be part of combination strategies with anabolic and anti‑resorptive agents in high‑risk patients.

10. Fertility and Younger Men: Risks and Mitigation

• Physiologic TRT suppresses LH/FSH and can rapidly shut down spermatogenesis even at relatively low doses, making fertility a major concern in reproductive‑age men.
• 
  
• Rising TRT use in younger men and explosive online prescribing (often for vague symptoms like fatigue) increase infertility risk.
• 
  
• Baylor protocols using hCG ± FSH (and sometimes SERMs) show:
  
  • High rates of sperm recovery after TRT‑induced azoospermia/oligospermia.
• 
  
• Dual hCG + FSH therapy accelerates recovery and can allow some men to remain on TRT while restoring sperm counts, though current brand‑only policies have made these regimens drastically more expensive.

11. Steroid Abuse vs Physiologic TRT

• The panel distinguishes physiologic TRT from supraphysiologic steroid abuse (often 600 mg/week and above, multi‑drug “cocktails” aiming for T levels >3,000–4,000 ng/dL).
• 
  
• Abuse yields:
  
  • Short‑term strength/muscle gains but significant adverse effects (cardiac, blood pressure, psychiatric, hematologic, dermatologic), up to sudden death and organ failure.
• 
  
• Social media is identified as a major driver of abuse due to glamorized outcomes and minimized risks.
• Key point: consistent resistance training alone can outperform couch‑sitting on high‑dose testosterone, underscoring that training, not abuse, is the primary driver of adaptive strength gains.

12. Military and OTC “Boosters”

• Service members have high physical demands and chronic stressors (sleep disruption, blast exposure, TBI) that can lower T, especially in Special Operations (“operator syndrome”), where low testosterone is common.
• 
  
• Stigma and fear of losing deployability or special duty status push many to:
  
  • Avoid formal care,
  • Seek outside clinics or illicit sources,
  • Or rely on over‑the‑counter “testosterone boosters,” which often have unproven ingredients and high rates of adulteration (including hidden steroids or testosterone itself).
• Reduced barriers and clearer policy around legitimate TRT are expected to reduce unsafe supplement and underground drug use.

13. Economic and Policy Arguments for TRT as Preventive Care

• Testosterone deficiency is framed as a “disease amplifier” across most major organ systems due to widespread androgen receptors.
• 
  
• Data from large VA cohorts show that normalizing testosterone in hypogonadal men is associated with substantially lower mortality and reduced heart attacks and strokes, implying multi‑billion‑dollar savings if scaled to Medicare and high‑risk populations.
• 
  
• With GLP‑1 use exploding and significant lean mass loss (≈40% of weight loss) on these drugs, the panel argues for fast‑tracking TRT as an adjunct to avoid a looming frailty crisis.

14. Call for a National Men’s Health Initiative

• The Assistant Secretary for Health highlights a broader men’s health crisis: shorter male life expectancy, higher mortality in 9/10 leading causes of death, high suicide rates (≈80% of suicides are men), obesity, substance abuse, and poorer healthcare engagement by men.
• 
  
• Proposed components of a national strategy:
  
  • Men’s Health Centers of Excellence with shared data and transparent outcomes,
  • Improved health literacy and health‑seeking behavior among men,
  • Parallel commitment to men’s health alongside women’s health programs.

15. Panel Consensus and Closing Themes

• Key consensus messages:
  
  • Testosterone deficiency is a serious medical condition with major health impacts, not a cosmetic issue.
• 
  
• Physiologic, monitored TRT is supported by high‑quality evidence as safe and beneficial for appropriate men.
• 
  
• Current FDA warnings (especially prostate) and age‑related restrictions lack support from modern data and should be revised.
• 
  
• Testosterone’s controlled‑substance status creates stigma and barriers without a sound evidence base and should be reconsidered.
• The meeting is framed as a landmark step toward an evidence‑based, individualized, and patient‑centered approach to men’s hormonal health, with the FDA committing to consider label revisions and further action

 

[newguy2]

Where is @Ghoul at? He usually comments on these.

 

[Ghoul]

Where is @Ghoul at? He usually comments on these.

Haha all over it bud.

The Feds are inviting public comment, from medical pros and the general public to guide future TRT therapy. They are asking very specific questions regarding how testosterone should be used to improve men’s lives going forward. As of last night there were 2 comments.

They can be made anonymously.

This is a GENERATIONAL opportunity for the community to change federal policy and medical guidance regarding testosterone access going forward.

We should set up a dedicated, pinned thread and coordinate a campaign to move this in the direction we’d like to see. Then reach out to other forums and invite them to participate as well.

If anyone would like to step up to manage this let me know and I’ll share the info I’ve gathered about how to properly submit a comment to the Feds on this.

There are 57 days left for the public comment period before the expert panel starts developing recommendations for changes to policy and law.

IMO this is EXTREMELY important for most of us here and an opportunity that should not be missed.

@Millard

 

[newguy2]

Haha all over it bud.

The Feds are inviting public comment, from medical pros and the general public to guide future TRT therapy. They are asking very specific questions regarding how testosterone should be used to improve men’s lives going forward. As of last night there were 2 comments.

They can be made anonymously.

This is a GENERATIONAL opportunity for the community to change federal policy and medical guidance regarding testosterone access going forward.

We should set up a dedicated, pinned thread and coordinate a campaign to move this in the direction we’d like to see. Then reach out to other forums and invite them to participate as well.

If anyone would like to step up to manage this let me know and I’ll share the info I’ve gathered about how to properly submit a comment to the Feds on this.

There are 57 days left for the public comment period before the expert panel starts developing recommendations for changes to policy and law.

IMO this is EXTREMELY important for most of us here and an opportunity that should not be missed.

@Millard

Man seriously that is a great idea. I'm actually blown away from the things they're saying on this panel. Lets go.