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Is DEA’s Proposed Rule the End of Online TRT Clinics?

 By Rick Collins, Esq.

 

Q: Is the DEA shutting down online TRT clinics by forcing in-person prescriptions?

 

A: Fitness social media circles have been lit up since March 1st when the Drug Enforcement Administration (DEA) published a new Proposed Rule in the Federal Register entitled “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation.”1 A few influencers uploaded alarming posts to the testosterone replacement therapy (TRT) community crying out for an “urgent call to action” and claiming that DEA was “forcing us to visit doctors every 30 days for refills.” The posts imply a conspiracy between Big Pharma and the U.S. government for the express purpose of depriving hypogonadal men from needed TRT.

 

As anyone who follows me here or on social media2 knows, I have a long history of calling out the government when it overreaches. I’ve often said that Congress in 1990 lacked the evidence to have classified testosterone and other anabolic steroids as controlled substances. These hormones starkly stand out as “the orange in the apple crate” of the federal Controlled Substances Act (CSA). But whether they belong there or not, they are subjected to all the same regulations as the other “drugs of abuse” in the CSA.

 

The DEA’s Proposed Rule concerns the Ryan Haight Online Pharmacy Consumer Protection Act of 20083 and its implementing regulations. While our community thinks of the Ryan Haight Act only in its application to TRT, the law was passed to stop “rogue Internet sites” illegally dispensing addictive substances like opiates without a valid doctor-patient relationship. It was named after 18-year-old Ryan Haight who died of a Vicodin overdose prescribed to him via a telemedicine consult by a doctor who had never met him in person and did not conduct an adequate medical evaluation. The Act requires, with limited exceptions, an in-person medical evaluation prior to issuing a prescription for controlled substances via telemedicine.

 

One exception is a public health emergency. In January 2020, the DEA announced that they were loosening remote controlled substance prescribing restrictions during COVID-19, rolling back select provisions of the Ryan Haight Act and allowing telemedicine (conducted using an audio-visual, real-time, two-way interactive communication system) to be used in place of in-person evaluations.4 The “emergency” is set to expire on May 11, 2023.

 

The Proposed Rule would allow for more flexibility than pre-COVID, so that’s a good thing. It would allow a patient to obtain a telemedicine prescription from an online TRT clinic without seeing a practitioner in person, but to get a refill he would need to have an in-person evaluation within 30 days. The patient could either see the prescribing practitioner in person or visit a local covering practitioner who then interacts in an audio-visual, real-time, two-way interactive communication with the prescriber (in that case, the patient never actually sees the prescribing practitioner). The problem is that the processes DEA is proposing are complicated, burdensome, and poorly suited to TRT. There’s more red tape and recording obligations which may make sense for opiates but seem silly for testosterone.

 

Again, the Proposed Rule only addresses the situation where NO in-person medical evaluation takes place prior to writing the script. Also, be aware that every state can have its own telemedicine laws, and that the Proposed Rule would be subject to any and all state laws. TRT clinics should ensure that their practices are compliant with both federal and state laws. But contrary to claims on social media, there is NOTHING in this rule that requires TRT patients to perpetually visit their doctors every 30 days for refills.

 

Many readers of this column strongly believe that both testosterone and masculinity itself are under attack today. I agree. But we must be careful about lumping everything into that narrative. TRT is only in the mix because anabolic steroids were bootstrapped by Congress (against DEA advice) into a law in which they didn’t belong in the first place. Cracking down on TRT may indeed be the goal of some regulators (e.g., look at FDA’s dubious “black box” warning on testosterone products) but the effect of this Proposed Rule upon TRT is a byproduct, not a primary focus. Until March 31st, DEA is accepting formal comments on the Proposed Rule at www.federalregister.gov/documents/2023/03/01/2023-04248/telemedicine-prescribing-of-controlled-substances-when-the-practitioner-and-the-patient-have-not-had, and many in the TRT community have reasonably suggested treating TRT with different, looser provisions than other scheduled drugs. Hopefully, DEA will listen.

 

Rick Collins, Esq., CSCS [https://rickcollins.com/] is the lawyer who members of the bodybuilding community and dietary supplement industry turn to when they need legal help or representation. [© Rick Collins, 2023. All rights reserved. For informational purposes only, not to be construed as legal or medical advice.]

 

WATCH THE FOLLOW UP VIDEO TO THIS ARTICLE!  

 

 

References:

 

1. www.federalregister.gov/documents/2023/03/01/2023-04248/telemedicine-prescribing-of-controlled-substances-when-the-practitioner-and-the-patient-have-not-had

 

2. www.instagram.com/rickcollinsesq/

 

3. www.congress.gov/110/plaws/publ425/PLAW-110publ425.pdf

 

4. www.deadiversion.usdoj.gov/GDP/(DEA-DC-023)(DEA075)Decision_Tree_(Final)_33120_2007.pdf

 

 

 

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