Because Ellsworth Law Firm has been involved in dozens of federal Internet pharmacy prosecutions, we are often asked about the enactment of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which took effect April 13, 2009 (except for the detailed definition of “practice of telemedicine,” which went into effect January 15, 2010).
Until very recently, federal law contained no specific provisions governing the practice of medicine and pharmacy by means of, or through the use of, the Internet. Nevertheless, various divisions and agencies of the federal government used more general statutes, rules, and regulations to influence, control, and punish new and controversial practices of medicine and pharmacy via the Internet through licensure, civil, and criminal proceedings.
The most severe federal enforcement against practitioners of medicine and pharmacy via the Internet (and business professionals associated with them) has come through criminal prosecutions under the general provisions of the Controlled Substances Act (“CSA”) that make it illegal to dispense or distribute controlled substances without a “valid prescription.” The definition of a “valid prescription” in these prosecutions has been drawn from a general federal regulation promulgated under the CSA requiring a purported prescription to have been issued for a “legitimate medical purpose” by a licensed practitioner acting “in the usual course of professional practice.” These vague terms, created long before widespread use of the Internet, have been the subject of heated legal fights, as lawyers for practitioners of Internet medicine and pharmacy have argued that innovations in science and technology render the old definitions inapplicable in the modern world, and prosecutors typically responding that so-called “Internet pharmacies” are nothing but old-fashioned “pill-mills” utilizing new technology.
As a legal matter, the federal courts have permitted prosecutors to bring criminal charges of drug-dealing to trial against doctors and pharmacists engaged in the practice of medicine and pharmacy via the Internet, as well as non-DEA registered businesspeople working with them. That said, because of the vague definitions on which the prosecutions turn – “valid prescription,” “usual course of professional practice,” “legitimate medical purpose” – defendants in these cases and their lawyers have been able to appeal to jurors’ sense of fairness, arguing that at the very least no criminal sanctions should be imposed in such a gray area. While several defendants have successfully used such arguments to prevail at trial, an overwhelming majority of prosecutions have resulted either in guilty pleas or convictions after trial.
In an effort to eliminate the ambiguity in the law and defendants’ use of “gray-area” arguments, in the fall of 2008 Congress passed and the President signed into law the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. The Online Pharmacy Act, which became effective April 13, 2009, primarily amends the Controlled Substance Act to prohibit, with limited exceptions, the distribution of controlled substances by means of the Internet, and to place significant registration, notification, and reporting demands on any “person, entity, or Internet site” deemed to be an “online pharmacy.” Further, the new law increases the maximum criminal punishments for those found guilty of violating the CSA, increasing the maximum term of imprisonment for illegal distribution of Schedule III drugs to 10 years (from 5 years), and of Schedule IV drugs to 5 years (from 3 years). The new law also makes it a federal crime for an online pharmacy – defined broadly to include almost any person or entity that utilizes the Internet to facilitate the distribution or delivery of controlled substances or to offer or attempt to distribute or deliver controlled substances – to violate State licensure requirements in either the State from which the pharmacy, or to which the pharmacy, dispenses or offers to dispense or deliver controlled substances.
In short, the Online Pharmacy Act rendered many of the previously ambiguous legal rules more definite and many of the previously gray areas more black-and-white.