THE DEA And ACCESS TO TRT TELEMEDICINE

[Psychedelic Anabolism]

Thanks @Nelson Vergel , I just have a fair amount of experience dealing with these types of federal rules and how they get adopted at this sort of sub agency level. Process, feedback, etc. working with industry groups, lobbyists, public commentary etc.

And I 100% agree about this site. It is BY FAR the best site for this information on the web. The rest of them are literal clown shows compared to this one. This forum is like taking a graduate level class in men’s hormones.


Do you know Rick Collins? Would love to hear his take on how he thinks this affects the industry, I would consider his take to be the definitive one, there’s really no one out there that understands the legalities of anabolics as well as he does.

I wouldn't get your hopes up about Rick Collins. He is full of himself and not really the expert he claims to be, you would clearly see this if you met him in person. There are far better experts out there being utilized by trade organizations, medical institutions, and pharmaceutical companies that compound or manufacture anabolic hormones. They just dont have a public platform or self-promote

 

[SteveCleves]

Believe it or not, commenting works if enough people speak up. In 2016, the DEA was dead set on scheduling an over-the-counter herbal product called Kratom. Kratom has been used for years by consumers for things like opioid withdrawal symptom management, as an alternative therapy for pain management, and for anxiety+pain+depression. These are mostly people who do not want to take SSRIs, opioids or benzodiazepines for their condition. While both the DEA and FDA were planning to make it a Schedule I substance, essentially making all forms immediately illegal, they did open a commenting period. Over 22,000 comments were received and the DEA backed down and withdrew its plan. Kratom is still available OTC.

Another reason why Kratom was saved was because a congressman got like 50 other congressman to sign a letter asking the DEA not to schedule Kratom. Not sure there is that kind of group in congress right now looking to save TRT.

Also, surprise surprise , that congressman retired and got hired as the head of the American Kratom Association. Is there a TRT advocacy group that is willing to dangle a high paying job in front of a congress member to save TRT? Lol

 

[Psychedelic Anabolism]

The reason why Kratom was saved was because a congressman got like 50 other congressman to sign a letter asking the DEA not to schedule Kratom. Not sure there is that kind of group in congress right now looking to save TRT.

Also, surprise surprise , that congressman retired and got hired as the head of the American Kratom Association.

There are a few Congressmen/Women aware of the DEA/RHA issue, some of Nelson's good friends have a call with one this week who happens to be on telemedicine TRT himself. Im not positing names as I dont want to risk anything for them. There are also large trade orgs and groups that are pushing back in various ways including commenting

And yes, thats exactly how it works on both sides. You pay to play, thats literally how the government game works. Feed the rats well and they wont come in and steal your food

 

[SteveCleves]

There are a few Congressmen/Women aware of the DEA/RHA issue, some of Nelson's good friends have a call with one this week who happens to be on telemedicine TRT himself. Im not positing names as I dont want to risk anything for them. There are also large trade orgs and groups that are pushing back in various ways including commenting

And yes, thats exactly how it works on both sides. You pay to play, thats literally how the government game works. Feed the rats well and they wont come in and steal your food

that’s actually really encouraging. A member of congress getting involved would have an enormous impact.

 

[Psychedelic Anabolism]

We learned through our trade org that Elizabeth Warren's team is actually floating a bill to de-schedule or lower the scheduling of testosterone. The primary focus in trans patients (FTM) using testosterone. The protected classes have the loudest voice and most likely to succeed. Reading some of the comments in the docket you will see a few from trans patients using telemedicine. We wouldnt even be discussing this if testosterone was not a controlled substance. The DEA didnt even want to control it as AAS dont qualify for the Controlled Substance Act, it was forced into Scheduling

Background:
Androgenic Anabolic Steroids (AAS) are Schedule III controlled substances under the Controlled Substance Act (“CSA”). They are also non-narcotic medications. They were not controlled under the original Act (1970), either specifically or categorically, but were subsequently controlled under a subsequent act in 1990, which added them as a definitional category to the CSA. Due to their unique status under the CSA, it is appropriate to treat them differently for the purposes of this proposed rulemaking; applying general rules not tailored to their particular medical use will result in unnecessary restraints being foisted on the telemedicine hormone replacement therapy market. These restraints will greatly reduce their accessibility, utility, efficacy, and otherwise result in administrative burdens that could impede the existing standard of patient care.

This is unnecessary, as the pharmaceutical industry, through prior actions, have led the way with self-regulation and self-policing, well in advance of regulatory or legislative intervention.

For example, in 1983 Ciba Pharmaceuticals discontinued sale of the best-selling AAS on the pharmaceutical market (methandrostenolone, under the trademark “Dianabol”). Following this industry-set example, in December of 1985, the Food and Drug Administration (FDA) sent a letter to domestic pharmaceutical firms instructing them to discontinue sale of certain specified AAS, including generic forms of Dianabol. All notified firms complied with the FDA directive and AAS such as Dianabol were successfully removed from the domestic market. Neither legislative action nor the rulemaking process was required. However, as a direct consequence of this void in the U.S. market, a Mexican pharmaceutical firm increased production of the unavailable drugs and attempted to fill the void by smuggling AAS across USA/Mexico border[1].

Consequently, in 1988 the first bill attempting to regulate an anabolic steroid (specifically to add methandrostenolone to the CSA) was introduced to Congress. At the subsequent congressional hearing, the DEA testified in opposition to the bill.

“In this respect, the law is poorly suited to the steroid drugs. It is clear,
based on the legislative history, that the Congress did not intend to encompass them
within it.”[2]

On 29 November 1990, President George H.W. Bush signed the Anabolic Steroids Control Act (ASCA) of 1990. The act took effect on 27 February 1991[3]. The Act established and regulated AAS under Schedule III of the CSA by adding twenty-five known AAS to the list of controlled substances.[4] An act of the legislature was necessary to add anabolic steroids to the CSA because, as the DEA testified, they could not be added administratively. For a second time, DEA took the official position that AAS failed to meet the criteria for scheduling, putting forth serious doubts as to the propriety of using the CSA to regulate this category of medicine.

“The Controlled Substances Act is built entirely and exclusively around drugs which are principally psychoactive and are abused almost exclusively by virtue and because of that property. All of these drugs can be described as either narcotics, stimulants, depressants, or hallucinogens.”

I don’t believe there exists now any evidence to indicate that this class of drugs [anabolic steroids] possesses those properties, or at least there is very little evidence. So, I have some serious doubts as to whether the Controlled Substances Act is the appropriate piece of legislation to consider.”[5]

Therefore, an exception was carved out of the existing structure, which served to control AAS under the CSA, despite DEA stating that this was inappropriate and a poor match with the legislative intent of the original Act.

As such, with respect to the fact that AAS do not fit the CSA’s criteria, nor its original legislative intent, it is especially inappropriate to apply DEA’s proposed modifications under DEA-407 to the RHA with respect to this class of medication. The “one-size-fits-all” approach to regulating all controlled non-narcotic medication under the same rules is contradicted by the fact that AAS are ill-suited for inclusion under the CSA as a whole.

On 22 October 2004, President George W. Bush signed into law the Anabolic Steroid Control Act of 2004 (“ASCA 2004”), which became effective on January 20, 2005.[6] The 2004 Act raised the total number of anabolic steroids listed in Schedule III from twenty-five to fifty-nine.[7] The new Act also removed the prerequisite that the anabolic steroid possesses per se anabolic properties and made illegal the sale of most so-called “prohormones.” In addition, Section 2(a) of the 2004 Act classified a drug or hormonal substance as an anabolic steroid if the following four criteria were met: (A) The substance is chemically related to testosterone; (B) the substance is pharmacologically related to testosterone; (C) the substance is not an estrogen, progestin, or a corticosteroid; and (D) the substance is not dehydroepiandrosterone (DHEA).[8] Therefore, hormones such as estrogen (the primary female sex hormone) are not controlled substances, while testosterone (the primary male sex hormone) is controlled under Schedule III of the CSA.

The new rules currently proposed by the DEA would therefore allow hormonal gender affirmation therapy transition therapy to commence and continue via telemedicine without the second in-person examination for male to female transgender persons (transgender females). But a second visit within 30 days, with the prescribing physician, would be required for those transitioning from female to male (transgender males). This is due to the fact that testosterone is an AAS, and subject to the newly proposed rules, while estrogen is not controlled[9] and thus not ensnared. To promote and ensure constitutionally guaranteed equal protection to similarly situated people undergoing gender affirmation through hormone therapy, DEA should exempt AAS like testosterone from the proposed regulatory structure.

Following ASCA 2004, on 18 December 2014, President Obama signed into law the Designer Anabolic Steroid Control Act (“DASCA”). DASCA was crafted to curtail the practice of synthesizing AAS that were designed to avoid control under the CSA through slight chemical modifications to existing structures. The Act also added 25 new substances to the existing list of steroids controlled under Schedule III, while granting additional powers to rapidly schedule emerging drugs that satisfy the definition set forth therein. Despite additional regulatory and scheduling control granted to DEA through DASCA, DEA has not found it necessary to promulgate new regulation or schedule additional AAS[10]. Additional restrictions on the telemedicine market as regards AAS, are therefore unwarranted as the framework provided through ASCA, ASCA 2004, and DASCA have produced a foundation remarkably and demonstrably effective at preventing diversion.

---

[1] Steroids Legal in Mexico; U.S. Demand Keeps Druggists Busy
[2] One Hundredth Congress, Second Session. Testimony regarding H.R. 3216. July 27, 1988.
[3] See generally: (Title XIX of Pub. L. 101-647), but see also DEA’s explanation and promulgation of same at: Regulations.gov, at “Background Information.”
[4] https://www.congress.gov/bill/101st-congress/house-bill/4658/text
[5] Id.
[6] Id.
[7] https://www.congress.gov/bill/108th-congress/senate-bill/2195/text
[8] Regulations.gov, at “Background Information”
[9] This is despite the fact that estrogen is known to be anabolic in multiple pathways. See: SHRIPAD B. DESHPANDE Shripad B. Deshpande, Neuroprotective Actions of Estrogen. Indian J Physiol Pharmacal 2000; 44(1). The anabolic properties of estrogen are well articulated and exploited in multiple domains, including animal husbandry where it is used alone or added to non-aromatizing AAS to produce an additive effect on anabolic hormones and weight gain. See: Pampusch, M. S., White, M. E., Hathaway, M. R., Baxa, T. J., Chung, K. Y., Parr, S. L., Johnson, B. J., Weber, W. J., & Dayton, W. R. (2008). Effects of implants of trenbolone acetate, estradiol, or both, on muscle insulin-like growth factor-I, insulin-like growth factor-I receptor, estrogen receptor-{alpha}, and androgen receptor messenger ribonucleic acid levels in feedlot steers. Journal of animal science, 86(12), 3418–3423. Effects of implants of trenbolone acetate, estradiol, or both, on muscle insulin-like growth factor-I, insulin-like growth factor-I receptor, estrogen receptor-α, and androgen receptor messenger ribonucleic acid levels in feedlot steers1
[10] Human Enhancement Drug Matters. Theme: Enhancement Drugs and the Criminal Justice System. 2652-9572 (Online), Volume 5, Issue 1. August 2022.

 

[BigTex]

IN SIMPLE WORDS:

Just going to get a physical exam with a local doctor will no longer be sufficient for a telemedicine clinics to treat you.

You will need to:

1. Get an exam by a practitioner with a state DEA license. Not all of them have this.

2. Your telemedicine doctor will need to be present virtually *during* this exam via two-way video or voice chat.

3. The practitioner you visit for your physical will have to keep medical records of your exact treatment from your telemedicine provider. So, whenever your treatment is changed, etc., the practitioner will need updated records from your telemedicine provider.

This brilliant plan by the DEA took place before there was telemedicine. Before addicts of Schedules III, IV, and V (oxycodone) went to doctors with a state DEA license, got a physical exam and got a script of 30 oxycodone. Records were kept before. Then they went on to the next doctor and did the same thing. So we ended up with lots of oxycodone addicts all over the USA. How hard it is to find a DEA licensed doctor? All here in Texas have them, even PAs have a state DEA license. So what will the DEA really accomplish other than putting the breaks on telemedicine which has made it easier for many patients to get medical attention, plus saves money. I have free telemedicine on my insurance.

 

[Psychedelic Anabolism]

This brilliant plan by the DEA took place before there was telemedicine. Before addicts of Schedules III, IV, and V (oxycodone) went to doctors with a state DEA license, got a physical exam and got a script of 30 oxycodone. Records were kept before. Then they went on to the next doctor and did the same thing. So we ended up with lots of oxycodone addicts all over the USA. How hard it is to find a DEA licensed doctor? All here in Texas have them, even PAs have a state DEA license. So what will the DEA really accomplish other than putting the breaks on telemedicine which has made it easier for many patients to get medical attention, plus saves money. I have free telemedicine on my insurance.

Oxycodone is schedule II, and you cannot receive any schedule II by pure telemedicine, so that itself mitgates potential abuse. Schedule III through V do not contain any narcotics except for tramadol and low dose codeine. Even tramadol is used in combination with PDE5s for premature ejaculation, always at doses too low to abuse. As you stated, these rules do nothing to mitigate diversion and only accomplish limiting healthcare and harming people. Drug 'abusers' will continue to buy their products from the many sources that are easily accessible online. We surveyed one large pharmacy that ships to 50 states and learned they serve over 2600 physicians who do some kind of telemedicine for either TRT or mental health, prescribing Schedule III to V medications. This is just one of the thousands of pharmacies. There are far more patients of many types using telemedicine to receive long-term managed care- and many dont realize these rules are about to potentially ruin their access to treatment. Also remember, the DEA and Boards of Pharmacy have already imposed a complex matrix of regulations that mitigate abuse and diversion, including PDMP (Prescription Monitoring Programs) that track all controlled substances. There is no need for these ridiculous rules against telemedicine

 

[Blackhawk]

I am unclear about the 30 day prescription limitation. Does this apply to just telehealth or in person care as well? What is the regulation for in person testosterone prescriptions by local providers?

 

[Psychedelic Anabolism]

I am unclear about the 30 day prescription limitation. Does this apply to just telehealth or in person care as well? What is the regulation for in person testosterone prescriptions by local providers?

The 30-day limitation dosnt apply to in-person visits. These rules only affect pure telehealth care

 

[Arcane]

I was listening to Joe Rogan's most recent podcast with Andrew Huberman today. towards the end of the episode they addressed this DEA Telemedicine situation. Huberman said to write letters

 

[Arcane]

The 30-day limitation dosnt apply to in-person visits. These rules only affect pure telehealth care

that defeats the purpose of Telehealth

 

[Psychedelic Anabolism]

I was listening to Joe Rogan's most recent podcast with Andrew Huberman today. towards the end of the episode they addressed this DEA Telemedicine situation. Huberman said to write letters

We caught that too, I just sent Chris Bell (Bigger Stronger Faster) this thread and a summary to forward to Joe Rogan. We are hoping that he covers it more thoroughly in time for commenting. Keep your fingers crossed

 

[AdamF]

Has anyone spoke with Defy Medical? Im curious what their stance is and what they are telling patients to do if anything.

 

[Psychedelic Anabolism]

Has anyone spoke with Defy Medical? Im curious what their stance is and what they are telling patients to do if anything.

From what I was told they are preparing a patient campaign today, going out via email to stimulate patient comments. I know some or all of their providers have submitted comments too. I have spoken with several of the larger telemedicine HRT clinics and they are all doing the same. The DEA gave a short window for this so everyone is moving quickly as they are trying to learn about the proposed rules. Threads like this are helpful to make it digestible

 

[Blackhawk]

Seems to me the whole comment thing needs to be more visible to every person who uses telehealth for hormone treatment. I suspect that there are many thousands who will never even know. What are other means to get this message to the masses? If the DEA receives a million comments could make more difference.

Is big media coverage a possibility?

There was mention of congressional requirement to actually consider public comment. What kind of activism could work at that level, i.e. contacting our representatives? I am not clear about how interactive this is between congress and the DEA.

 

[Arcane]

Seems to me the whole comment thing needs to be more visible to every person who uses telehealth for hormone treatment. I suspect that there are many thousands who will never even know. What are other means to get this message to the masses? If the DEA receives a million comments could make more difference.

Is big media coverage a possibility?

There was mention of congressional requirement to actually consider public comment. What kind of activism could work at that level, i.e. contacting our representatives? I am not clear about how interactive this is between congress and the DEA.

Joe Rogan and Andrew Huberman discussed it. I think Mark Bell might have too.

 

[Nelson Vergel]

 

[Blackhawk]

Joe Rogan and Andrew Huberman discussed it. I think Mark Bell might have too.

How about the tabloids like Fox, CNN NPR etc?

 

[Arcane]

How about the tabloids like Fox, CNN NPR etc?

probably not. Not feeling very optimistic about all this. Also figured it was only a matter of time

 

[Psychedelic Anabolism]

probably not. Not feeling very optimistic about all this. Also figured it was only a matter of time

There have been some media exposure around this:

DEA rules on prescribing controlled substances roil behavioral health

A federal crackdown on overprescribing controlled substances via telehealth is causing confusion and consternation in the behavioral health community

www.axios.com

Unwinding of COVID emergency brings hurdles for gender-affirming care

Advocates, lawmakers warn that Biden telehealth rule will worsen opioid crisis

A new rule proposed by the DEA would require an in-person examination for telehealth patients who want to stay on the addiction-treatment medication buprenorphine for longer than 30 days.

www.statnews.com

DEA Controlled Substance Telehealth Proposals Draw Fire

Two US Drug Enforcement Administration proposals on how telehealth can be used going forward to prescribe controlled substances are drawing criticism from mental health and addiction treatment specialists.

www.medscape.com

https://www.fastcompany.com/90867065/future-of-telehealth-public-health-emergency-ending

There is more if you search online. Ive seen some stuff pop up in my news feeds lately. Of course, it may not be enough to stimulate comments in time.

I am optimistic overall, there is strong pushback from multiple industries and health fields that may likely get this held up in the courts. Keep the comments rolling