The final Rule on the “Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act” (aka Ryan Haight Act) was published in the Federal Register Monday, April 6, 2009, by the DEA and DOJ. It can be found here. It draws some interesting conclusions with respect to Internet pharmacy law. Simply put, the new Regulations only serve to increase already existing legal ambiguity. I have exhaustively read through it, and below is my analysis:
1. Ryan Haight Act Effective Date: The Rule confirms that the Ryan Haight Act becomes effective on April 13, 2009. Most of the interim Rule also becomes effective on that date. The Rule all but admits that the DEA was rushed to get the Rule out:
It is evident from the forgoing provision of the Act that Congress contemplated it would be necessary for the DEA to issue regulations on an interim basis in order to implement the Act within a relatively short time period . . . Indeed, Congress envisioned that DEA would need to issue interim rules “prior to its effective date” to effectively implement the new requirements of the Act. Accordingly, the rules published here are effective immediately while at the same time the agency is seeking public comment on them.
The fact that they waited until one week prior to the Ryan Haight Online Pharmacy Consumer Protection Act’s effective date to publish the Rule is not surprising. I imagine that the DEA had to carefully craft the Rule’s Ryan Haight Act summary to minimize the disturbance on pending federal criminal indictments. In any event, the rushed nature of the Rule only serves to make Internet pharmacy law even more ambiguous.
2: More Support That Pending Pre-Ryan Haight Internet Pharmacy Federal Indictments Are Invalid: It is apparent from the Rule that the DEA and DOJ are still confused as to whether the lack of a doctor’s face-to-face medical examination prior to the issuance of a prescription is illegal before the effective date of the Ryan Haight Act. A number of quotes from the Rule stand out:
The law becomes effective April 13, 2009. Thus, as of April 13, 2009, it will be illegal under federal law to ‘deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized [by the CSA]‘ or to aid or abet such activity.
The Ryan Haight Act . . . makes it unlawful to “knowingly or intentionally deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized by the [the Act].
Here, the Act makes it unambiguous that, except in limited and specified circumstances, it is a per se violation of the CSA for a practitioner to issue a prescription for a controlled substance by means of the Internet without having conducted at least one in-person medical evaluation.
The Ryan Haight Act adds two new criminal offenses to the CSA. The first new offense is set forth in 21 U.S.C. 841(h)(1), which states: It shall be unlawful for any person to knowingly or intentionally deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized by [the CSA].
The use of the words “will,” “makes,” and “new” are, of course, nothing but supportive of my pre-Ryan Haight Act suspicions. If the DOJ and lawmakers can’t figure it out, how can lay individuals be presumed to know, beyond a reasonable doubt, of their “illegal” activity?
3. The rule emphasizes the fact that an Internet pharmacy does not automatically shield itself from arrest and ultimately prosecution merely because it complies with the one face-to-face medical examination requirement of the Ryan Haight Act:
At the same time, it is crucial to bear in mind that, as Congress expressly stated under the Act, the mere fact that the prescribing practitioner conducted one in-person medical evaluation does not demonstrate that the prescription was issued for a legitimate medical purpose within the usual course of professional practice. Even where the prescribing practitioner has complied with the requirement of at least one in-person medical evaluation, a prescription for a controlled substance must still satisfy the additional, fundamental prerequisite that has been legally mandated for more than 90 years: it must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
A rogue Internet operation cannot, for example, defeat the purpose of the Act by establishing a method of operation in which a practitioner conducts a perfunctory in-person “evaluation” of each “patient” simply for the purpose of selling prescriptions for controlled substances to the patient in perpetuity with no follow-up visits.
In other words, even if a doctor performs one face-to-face evaluation, the prescription still must be issued for a legitimate medical purpose and in the usual course of professional practice. Thus, we are right back to square one: extreme ambiguity. Congress and the DEA are saying follow this law but, if you do, you can still be convicted.
4. The Rule assumes pharmacies conducting business online can recognize that they are filling prescriptions not for a legitimate medical purpose and not in the usual course of professional practice merely based on the number of prescriptions they are filling relative to brick and mortar pharmacies that lack an online business component:
The small percentage of pharmacies who have so participated in these rogue Web site schemes have, in many cases, filled extraordinary numbers of prescriptions for controlled substances that dwarf the sales figures of walk-in pharmacies.
This is fallacious. You can’t compare the prescription numbers of an Internet based pharmacy and a non-Internet based pharmacy. The two have different customer bases and demographics. Simply put, one has the ability to fill prescriptions for individuals nationwide, and the other has the ability to fill prescriptions for individuals within the local community. In U.S. v. Fuchs, the government tried to offer a witness to testify as to prescription numbers. Though dicta, the 5th Circuit Court of Appeals implied that this was improper.
In short, this Rule provides more great ammunition for criminal defense lawyers involved in pre-Ryan Haight Act indictments and internet pharmacy law appeals. I am looking forward to adding it to my future Motions to Dismiss and Internet Pharmacy Law Appellate Briefs.
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 lawyer knowledgeable in prescription, drug and internet pharmacy law, including the Controlled Substances Act, the Ryan Haight Act amendment and Federal Food, Drug and Cosmetic Act violations, please feel free to contact me directly.
Category: Internet Pharmacy Law
