More Than One Way To Skin A Cat: Prosecuting Internet Prescribing
by Benjamin N. Gluck, Bird, Marella, Boxer, Wolper, Nessim, Drooks & Lincenberg, Los Angeles, CA
Anyone with an email account should be familiar with the proliferation of Internet sales of prescription medicines. Email offers for prescriptions have been estimated to make up 16% of all email traffic on the Internet. With total email traffic in the billions per day, that's a lot of offers. And this does not even include offers made by banner ads or search engine placement methods. In short, buying prescription medications through the Internet is easy. But is it legal? Answering this question is more difficult than one might assume. This is because the most important laws governing prescriptions were drafted and enacted long before the Internet was part of our lives. Since there is no law explicitly barring Internet prescribing, the Government has tried several different tacks by which to prosecute it. Which approach, if any, will be the most successful has yet to be determined. While a complete discussion of this subject would be too much for this publication, this article briefly summarizes some of the more prominent theories.
1. What is "Internet Prescribing?"
The prescription offers cluttering the Internet represent various distribution models, some of which are easily dealt with. At the far end of the spectrum are companies that blast email offers for prescription medications with no doctor involvement at all. These companies simply take an order from a customer and ship medication into the country from places like India, Russia, or China. There are no "pill bottles" with doctor's signatures on them. Instead, there is usually just a blister pack of pills in an envelope. Sometimes these drugs are counterfeit, or even sugar pills. Such distribution schemes are easily dealt with under current law: 18 U.S.C. § 841 prohibits the distribution of controlled substances without a valid prescription. A prescription is defined as an order issued by a doctor in the usual course of professional practice. Because no doctor is involved in this scenario, the distributor of these drugs can easily be prosecuted under § 841. Indeed, it is probably a misnomer to call this "Internet prescribing," as there is no "prescribing" at all.
The harder question is presented by a scenario at the other end of the spectrum: There are numerous websites that distribute FDA-approved U.S. drugs. These sites hire U.S. licensed doctors to review online questionnaires in which the customer explains his or her need for the medication. Upon approval, a U.S. licensed pharmacy mails the drugs to the customer in a package with FDA-approved labeling and use instructions. This is the scenario that the government (and the online industry) is grappling with.
2. Drug Trafficking
Initially, the Government attempted to prosecute Internet prescribing by relying on § 841. This section is part of the Controlled Substances Act, which is commonly used to prosecute drug crimes. While it may seem unusual to prosecute doctors and pharmacists under the same statute used for heroin dealers, that is exactly how the government sees Internet prescribing.
In any event, federal statutes prohibit all distribution of controlled substances except for those with valid prescriptions. To be valid, the prescription must be issued for a "medical purpose" and in the "course of professional practice." Federal regulations provide: "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."
With this background, the government's theory is simple. Essentially it is a three-part argument: 1) "Under federal and state law, for a doctor to be acting in the usual course of professional practice, there must be a bona fide doctor/patient relationship;" 2) "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;" and, therefore 3) a prescription based on an online questionnaire is not valid. This means that § 841's blanket prohibition of distribution applies -- so that doctors and pharmacists who fail to adhere to these requirements should be treated no differently from drug dealers.
While this theory of enforcement is attractively simple, it suffers from a fundamental flaw: It is not at all clear the DEA is right when it says that an online encounter cannot create a doctor-patient relationship.
As an initial matter, federal statutes and recent case law emphatically hold that the DEA has no authority to determine medical standards. Indeed, this was a central issue when the Controlled Substances Act was enacted and Congress assured the medical community that the practice of medicine would not be second-guessed by law enforcement agencies. So the DEA is correct only to the extent that it accurately reflects already existing standards in the community.
And there is reason to argue that the community disagrees with the DEA and holds that online encounters can establish a doctor-patient relationship, which means that online questionnaires may very well be legal. For example, in an April 2002, the Federation of State Medical Boards opined that an online encounter does establish a doctor-patient relationship. Other medical organizations seem to agree with this position. As a legal matter for purposes of professional liability, it is well-accepted that a doctor-patient relationship is established without a face-to-face encounter. And Congress seems to disagree with the DEA as well.
In short, although the "drug trafficking" theory of prosecution has the benefit of being simple, it is probably wrong.
3. State Laws
Another theory of prosecution involves relying on state laws to prove the illegality of online questionnaires. This theory argues as follows: 1) Numerous states prohibit online prescribing; 2) a prescription that violates a state law can hardly be called within the "usual course" under the Controlled Substances Act; and, 3) this then means that the distribution was without a prescription. In other words, this theory allows the government to use state law to "prove" the invalidity of an online encounter.
The problem with this theory is twofold. First, except for Nevada and Virginia, no state says that an online prescription is invalid. Instead, the 28 states that address the problem deem it to be unprofessional conduct. But this does not mean that the prescription is therefore necessarily invalid. "A physician's conduct may constitute a violation of applicable professional regulations as well as applicable criminal statutes. However, a violation of a professional regulation does not in and of itself establish a violation of the criminal law."
The second problem with the state-law theory is that the definition of "usual course" for purposes of federal law must be a consistent national standard. In United States v. Moore, the seminal case applying § 841 to physicians, the Supreme Court approved jury instructions providing guilt only if the physician dispensed other than "in the usual course and in accordance with a standard of medical practice generally recognized and accepted in the United States." Numerous federal decisions echo this holding. Indeed, the Department of Justice has argued for just such a national standard, noting that Moore requires physicians to follow "standards generally recognized and accepted throughout the nation."
In short, the state-law theory suffers serious flaws and should not be used as a basis for federal prosecutions.
4. Other Theories
In light of these problems, recent prosecutions have focused on narrower and simpler theories. For example, even "careful" distributors of online prescriptions often have problems in their business models, such as selling to minors or allowing a single doctor to review hundreds or even thousands of questionnaires a day. In these scenarios, it is easy for the government to argue that the prescription fails the basic standards of medical care and therefore the distribution violated the Controlled Substances Act. Of course, the defendant distributors in such cases can argue, among other things, that they relied on the professionals, namely the doctors and pharmacists, to exercise medical judgment.
In a different approach, a recent prosecution alleged fraud by a distributor based on the theory that its web site falsely claimed that the business model was "100% Safe And Legal." It has yet to be seen whether this theory will succeed.
What is notable about these other theories is that they essentially ignore the basic question of whether an online encounter is inherently invalid. And because they do not attack the central element of online prescribing, they make it harder to prosecute. But until the law is clarified, this may be the best the government can do.
Because the Internet presents scenarios what were unimaginable just a short time ago, it should come as no surprise that pre-existing statutes have trouble addressing them. At this point, this much is clear: the government does not like online prescribing and it is doing what it can to prosecute it. Which theory of prosecution is settled on and the outcome of the government's efforts remain to be seen. In the meantime though, the unsettled nature of the law means that there is much that energetic defense counsel can do to challenge the government's theories.