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.
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