The U.S. “Department of Justice”http://usdoj.gov announced that a Virginia doctor, Torino Jennings of Mechanicsville, has been indicted for violation of the (federal) Food, Drug and Cosmetic Act, and for tax evasion. At the heart of the indictment was Dr. Jennings alleged filling of prescriptions for Soma (and presumably other drugs), a “legend drug” (non-controlled substance) without ever seeing the patient in person.

DOJ alleges that:

…between 2004 and 2007, (Dr. Jennings) issued between 50,000 and 100,000 prescriptions over the Internet for Soma, and other drugs, to individuals whom he had never performed a physical examination on and had never met…based on forms completed by individuals for online pharmacies. (And) the online pharmacies paid JENNINGS between $5.00 and $7.00 for each prescription he wrote.

There are a couple of interesting and important things about this.

1. The Ryan Haight Online Pharmacy Consumer Protection Act explicitly made the filling of a controlled substance prescription without ever having seen a patient in person a violation of the Controlled Substances Act. However, there has been substantially more debate about whether existing law prohibits filling a prescription for a non-controlled substance in the same manner.
2. It is interesting that DOJ is basing its prosecution not merely on violation of the FDCA, but also apparently tax evasion.
3. Historically, we’ve seen the average amount that a physician receives per prescription (for controlled substances) based on online consultations in the $2 – $4 range, although certainly sometimes much higher.

So what’s really going on here? Our analysis: rogue online pharmacy operators have shifted (not entirely, but meaningfully) to selling non-controlled substances like Soma, tramadol, fioricet, and erectile dysfunction drugs, based on the (we believe) false premise that no in-person examination is usually required for those drugs, and that they could escape enforcement or regulatory oversight. But Soma, tramadol and other drugs are in the small category of abusable (addictive) drugs that are nevertheless non-controlled substances. It was only a matter of time until federal and state law enforcement, now that the Ryan Haight Act is fully implemented and enforceable, were going to turn their attention to non-controlled substances.

What about the involvement of the IRS and the tax evasion charges? It would probably be a mistake to conclude that if a physician simply reports income obtained in this way, that they will avoid scrutiny. Rather, it’s largely a method that law enforcement uses to go after illicitly obtained revenue, and an additional hammer that the Department of Justice can use.

All of that said, this is an important case to watch. If it fails, it’s going to embolden those who argue that Soma, tramadol, Viagra, Fioricet, Propecia and other drugs can be sold over the Internet by online pharmacies that don’t require you to see the physician (or an associate of the physician) in person. But in that case, a likely result will be a movement to enact federal legislation that expands the Ryan Haight Act requirements to non-controlled substances, to clarify the law on that point. On the other hand, if the prosecution succeeds, it will embolden law enforcement who will see these cases as winnable and a source of asset recovery, and will set some degree of precedent. (However, it will also embolden those who argue that no additional law, or clarification of existing law, is needed.)

LegitScript does not approve any pharmacy website that facilitates the sale or filling of any prescription drug based solely on an online consultation.