The Ryan Haight Act (also known as The Ryan Haight Online Pharmacy Protection Act) is making its way through Congress on its way to the President’s desk. Almost unanimous congressional support exists for the Bill, and President Bush has previously declared his support for it in his March 2008 radio address. Thus, barring unexpected circumstances (a financial crisis anyone?), the Bill will inevitably become law.
The Ryan Haight Act undoubtedly expressly attempts to restrict many forms of internet pharmacy operations, unlike The Controlled Substances Act, which it seeks to amend. The question is what effect will it truly have upon internet pharmacy criminal law and the operation of online consultation service and questionnaire websites. The answer requires a detailed analysis of the Bill’s language.
Keep in mind, as I have mentioned previously in my internet pharmacy prescription criminal defense legal issues discussion, the Ryan Haight Act does not regulate conduct prior to its enactment (in other words, it does not appear to be retroactive). Thus, how could the DEA ever declare prior conduct illegal (as it does now) when the Ryan Haight Act seeks to make it illegal? It is extremely puzzling to me. The DEA can’t have it both ways. Either they admit that the Ryan Haight Act is redundant, unnecessary law or that the Ryan Haight Act seeks to outlaw previously legal behavior. The DEA is not alone in their inconsistencies. The National Community Pharmacies Association released a press statement yesterday emphasizing the need for the Ryan Haight Act because 96% of online pharmacy business were illegal. Huh? We need an act to make something illegal that is already illegal? I digress…
The Ryan Haight Act attempts to clear up the ambiguity associated with with what constitutes valid prescriptions. The current version of the The Controlled Substances Act makes it illegal to distribute any of its schedule III and IV drugs; however, it exempts from prosecution individuals that have licenses to distribute controlled Schedule III and IV substances with a valid prescription (i.e. physicians). 21 USC 829(b). The CSA refrains from noting what a valid prescription is. Instead, one must look to the C.F.R. 1306.04(a):
“A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.
The confusion lies, as I have previously discussed, in what actually constitutes “acting in the usual course of professional practice.” Previous cases and the DEA equate that to the need for a doctor-patient relationship. Unfortunately, the Federation of State Medical Boards has expressly said that online consultations without doctor physical examinations do, in fact, constitute doctor-patient relationships.
The Ryan Haight Act amends The Controlled Substances Act and attempts to sidestep any CFR confusion by expressly stating what is and is not a valid prescription. The act is essentially a definitional amendment giving more substance to The Controlled Substances Act. The following definitions are the most relelvant for our discussion:
- “No controlled substance may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.”
- “The term ‘valid prescription’ means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by (i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or (ii) a covering practitioner.”
- An in-person medical evaluation is defined as “a medical evaluation that is conducted with the patient in the physical presence of the practitioner.”
- Finally, “the term `deliver, distribute, or dispense by means of the Internet’ refers, respectively, to any delivery, distribution, or dispensing of a controlled substance that is caused or facilitated by means of the Internet.”
I will certainly admit that this statute makes many future internet pharmacy indictments much tougher; however, this act is not without its problems. I will summarize my initial thoughts here, all to be detailed in later blog posts:
- The act is an amendment to The Controlled Substances Act. It specifically limits the in person medical requirement to controlled substances. Keep in mind this section begins with “[n]o controlled substance may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.” It appears that Congress is not requiring face to face for non-controlled substances.
- The act does not appear to require a face to face examination for all Controlled Substances. It appears to only require a face to face examination for Controlled Substances purchased over the internet. The definition of valid prescription is within the internet specific amendment section and no effort is made to extend it to non-internet facilitated transactions such as telephone consultations or fax services.
- Relatedly, to be illegal, the dispensing, distribtuion, and delivering must be facilitated by the internet. Likely, courts will find a liberal definition of facilitation as they do with mail fraud. However, it will be interesting to see how this plays out and what constitutes facilitation.
- The act uses the phrase “medical evaluation” rather than “physical examination.” What is the difference? Intuitively, it sounds as if a medical evaluation is something less than an examination. It also will be interesting to see how this plays out.
- The statute provides exemptions for covering physicians and telemedicine specialists.
*A covering physician is a physician covering for a primary physician who has performed a physical evaluation within the past 24 months and is currently unavailable. What does currently unavailable mean? vacation? sleeping? busy with other patients? This could get tricky.
*A telemedicine doctor is a physician at a location remote from the patient and health care professional treating the patient using telecommunications to treat the patient for a legitimate medical purpose and in the usual course of professional practice. I, for one, am happy that Congress sought to expressly legalize this practice, given the difficulties obtaining quality health care in very rural areas.
As you can see, the Ryan Haight Act is not without holes. I will be discussing many of these points individually and in detail in the future.
The content on this post does not constitute legal advice and is for informational purposes only. You should not act upon the information presented on this website without seeking the advice of legal counsel. Should you wish to speak to an experienced criminal defense attorney knowledgeable in internet pharmacy, prescription, and drug law, please feel free to contact me directly.
Tags: Controlled Substances, Criminal Appeals, Criminal Defense, Internet Pharmacy Law, Ryan Haight Act