This is the first in a series of posts outlining the major legal issues associated with internet pharmacy prosecutions. Today, I will be outlining the typical federal distribution of a controlled substance case against online pharmacies, pharmacists, doctors, and prescription website owners (online consultation and direct prescription services, as well as no record pharmacies). Note that while many states have similar laws and are prosecuting internet pharmacies and disciplining licensed professionals, the DEA and DOJ have been much more active and the potential punishments are much more significant. Thus, I am outlining their case here.
Most federal cases against doctors prescribing, pharmacists filling, and website owners facilitating internet prescriptions are brought under The Controlled Substances Act(CSA). 21 U.S.C. 801-971. The CSA governs the manufacture, distribution, and dispensing of controlled substances. This is the statute in which cocaine, meth, etc. distributors are traditionally prosecuted as well. The statute attempts to classify controlled substances into five “schedules,” depending upon their degree of potential addiction and abuse, with Schedule I drugs being the most addictive. Schedule III includes, for example, hydrocodone (Vicodin). Schedule IV includes, for example, Alprazolam (Xanax) and Zolpidem (Ambien). The CSA generally makes it illegal to distribute any of the scheduled drugs; however, it exempts from prosecution those individuals that have licenses to distribute controlled Schedule III and IV substances with a valid prescription (i.e. physicians). 21 USC 829(b).
Therefore, the entire basis for CSA prosecutions of the individuals associated with an internet pharmacy (the owner, pharmacist, and doctor) rests completely on whether the prescription was illegitimate (and, thus, not even a prescription at all). If it was legitimate, then the players did nothing wrong, pursuant to the CSA. If it was invalid, however, the DEA believes that all members can be prosecuted.
Whether a prescription is valid under federal law is anything but clear, unfortunately, despite what the Government might believe. The Government looks to 21 C.F.R. 1306.04(a) to determine the standard for valid prescriptions:
“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 responsibility for the proper prescribing and dispensing of the controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of 21 USC 829 and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to penalties provided for violations of the provisions of law relating to controlled substances.”
One would think that the CFR would help rather than just add to the confusion of what constitutes a valid prescription. The phrase “practitioner acting in the usual course of his professional practice” has received some judicial scrutiny (unfortunately most on instructional issues). The scrutiny it has received, however, was not enough to determine its true meaning. The DEA has drafted guidelines in attempt to provide greater clarity. DEA Guidance 66 F.R. 211810-01, April 27, 2008 states:
“Under federal and state law, for a doctor to be acting in the usual course of professional practice, there must be a bonafide doctor-patient relationship.”
“Completing a questionnaire that is then reviewed by a doctor hired by the Internet Pharmacy could not be considered the basis for a doctor – patient relationship.”
Thus, the Government’s argument can be summarized as follows: To distribute controlled substances legally under the CSA, one must write a valid prescription. A valid prescription is one issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. The DEA implicitly states, via its Guidelines, that the usual course of professional practice requires a doctor-patient relationship. Because online consultations do not constitute a doctor-patient relationship, the website owners, pharmacists, pharmacies, and doctors can all be prosecuted under the CSA.
The traditional way that the DOJ then drafts its indictment is to include conspiracy counts to distribute controlled substances for all the players, individual counts against each player for the distribution of controlled substances, and, finally, counts for money laundering and criminal forfeiture.
An astute reader (if you have made it this far) might recognize the tremendous number of holes and fallacies entrenched within the Government’s analysis, most of which occur when the DEA starts discussing a doctor-patient relationship.
The remaining several parts of this series will cover all of the perceived holes and criminal defense strategies associated with the DOJ and DEA’s analysis individually and in more depth; however, I will outline them here so that you know in advance what is in store over the next week or two:
- Where did the DEA get the idea that a doctor-patient relationship was required? The CFR does not include that term whatsoever. It only requires that the prescription be issued for a legitimate medical purpose and in the usual course of professional practice. Does the doctor-patient relationship issue serve to add an additional requirement onto the CFR or does the DEA believe that a doctor-patient relationship subsumes the two requirements in the CFR? Either way, the DEA Guidelines can not trump the CFR.
- Even if a doctor-patient relationship was required, why is an online consultation not one? A doctor, after thoroughly reviewing medical records, probably has done more than one’s average GP doctor. Additionally, the Federation of State Medical Boards has expressly indicated that online consultations do constitute doctor-patient relationships.
- How can a website owner be punished under the CSA? Certainly no one can argue that prescriptions without face-to-face consultations are so obviously outside the usual course of professional practice that everyone, even non-medical professionals, should recognize its illegality. No one can tell me that a online consultation website owner, if they are not professional doctors or pharmacists themselves, should be able to determine that OCS is so far outside the usual course of professional practice to satisfy the mens rea requirement under the statute.
- How can a pharmacist KNOW that the prescription was issued outside the course of professional practice? Obviously there are certain cases where it might be obvious (e.g. where the pharmacy all of the sudden was filling 700% more Vicodin pills than normal or where the doctor and patient’s addresses do not corroborate each other); however, in many cases, I believe that this might be questionable at best.
- There is a possible constitutional vagueness argument concerning a lay website owner (as long as this person is not a doctor or pharmacist) truly understanding what the “usual course of professional practice” means. Certainly, Congress believes the statute lacks clarity themselves. Otherwise, they would not find the need to try and pass The Ryan Haight Act, which would explicitly invalidate prescriptions without face to face consultations.
- There is another possible constitutional argument that lay website owners might not have adequate notice that they are covered under the CSA. As you will note that statute and corresponding CFR say nothing about website owners. They speak solely to pharmacists and physicians. However, there is a section of the CSA which states:
“It shall be unlawful for any person knowingly or intentionally to use any communication facility in committing or in causing or facilitating the commission of any act or acts constituting a felony . . . the term “communication facility” means any and all public and private instrumentalities used or useful in transmission of writing, signs, signals, pictures, or sounds of all kinds and includes mail, telephone, wire, radio, and all other means of communication.”
Clearly this section covers doctors and pharmacists who use websites, but what is entirely unclear is whether it also covers the “communication facility” owners. Obviously in terms of the mail, it can not logically be meant to cover the post office who facilitates your packages getting to you. Consequently, how could it cover the website owner who also merely facilitates the drugs arriving at your door?
As you can see, there is a lot to talk about. I hope over the next few weeks you can stay with me as I go into each of these issues in significant depth.
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.
Category: Court Cases DEA Direct "Script" Doctors Internet Pharmacy Law Online Consultations Pharmacies Website Owners