Prescribing medicine for online pharmacies: an assessment of the law and a proposal to combat illegal drug outlets.

• Author: Lipman, Bethany

In 1999, Clayton Fuchs developed a business plan that would allow him to use his pharmacy license and the rapidly developing internet consumer market: he established an online pharmacy. (1) Fuchs set up Friendly Pharmacy, a company that allowed customers to visit a website, complete an online profile, and order their prescription drugs of choice. (2) Fuchs' website then forwarded those orders to a physician for his review. (3) The physician, who was licensed and living in Texas, never once spoke to or physically examined any of his "patients" before issuing their prescriptions. (4) After he approved the orders, Friendly Pharmacy's employees filled the prescriptions and shipped them to consumers around the country. (5) Although the online pharmacy used several compliance checks, (6) Friendly Pharmacy filled virtually every order customers placed. (7) When a Field Compliance Officer with the Texas State Board of Pharmacy ("TSBP") informed Fuchs that Friendly Pharmacy was operating illegally, (8) he moved his operation across the state line to Oklahoma where he began Main Street Pharmacy, another drug distribution website (9) that operated for several additional years before authorities shut it down.

Among Fuchs' customers was Ryan Haight, a seventeen-year-old high school honors student who began buying prescription drugs from his family's home computer in California. (10) He purchased Vicodin and other drugs from Fuchs' online pharmacy. (11) On February 12, 2001, Ryan Haight died from an overdose of prescription drugs Fuchs' business delivered to his doorstep. (12) Haight's story inspired amendments to the Controlled Substances Act ("CSA"), called the Ryan Haight Online Pharmacy Consumer Protection Act, (13) which took effect in April 2009 (nearly ten years after Haight's death).

By the time federal officials shut down Fuchs' second internet operation in 2001, (14) "the pharmacy was processing between 300 and 500 prescriptions per day, approximately seventy percent of which were for hydrocodone," a Schedule III controlled substance. (15) Fuchs paid prescribing physicians according to the number of prescriptions they approved, (16) motivating the doctors to approve large numbers of prescriptions with minimal consideration. Fuchs' online operations ultimately generated more than $8 million and distributed prescription drugs to thousands of consumers nationwide. (17) A jury convicted Fuchs of conspiracy to distribute controlled substances, operating a continuing criminal enterprise, and money laundering. (18) He is now serving twenty years in prison. (19)

Government officials have noted the Ryan Haight Act's apparent success at "virtually eliminat[ing]" the types of illegal online pharmacies described above. (20) However, others argue that the threat has not been eliminated because these and other types of these pharmacies still exist. (21) Prescription drug use is the second most common form of drug abuse in the United States. (22) A recent survey indicated that "approximately seven million Americans currently use prescription-type psychotherapeutic drugs non-medically." (23) The Office of National Drug Control Policy calls prescription drug abuse "the Nation's fastest-growing drug problem." (24) While there were 4,000 deaths resulting from prescription drug overdoses in 1999, such deaths "now outnumber deaths involving heroin and cocaine combined, accounting for 20,044 of 36,450 overdose deaths in the U.S. in 2008." (25) In addition to the human cost, drug abuse and addiction totals an estimated $193 billion in preventable health care, law enforcement, crime, and other expenses every year. (26)

Although the vast majority of those abusing prescription drugs obtain them from friends or relatives, (27) the rise of the internet has likely contributed to the problem. As of 2010, 77.31 percent of American adults had access to the internet. (28) The amount of money generated by the online prescription drug industry reached an estimated $15-20 billion in 2004. (29) A 2011 study noted, "states with the greatest expansion in high-speed Internet access from 2000 to 2007 also had the largest increase in admissions for treatment of prescription drug abuse." (30)

Despite the apparent success of enforcement initiatives such as the passage of the Ryan Haight Act, (31) in October of 2012 the National Association of Boards of Pharmacy ("NABP") reported that 9,830 of the 10,161 internet drug outlets it reviewed, or 96.74 percent, were operating out of compliance with federal and state laws and/or NABP safety and pharmacy practice standards. (32) These findings indicate illegal online pharmacies still exist, even if they have evolved as a result of law enforcement efforts.

This Note's purpose is twofold. First, it explains how the existing regulatory scheme has ostensibly eliminated the threat created by illegal domestic internet pharmacies that use licensed practitioners to issue and fill prescriptions. Second, it makes recommendations to combat remaining pharmacies that fall into the above category in addition to the more prevalent rogue internet pharmacies offering prescription drugs without employing licensed practitioners. Part I of this Note will provide an overview of the various types of internet pharmacies. Part II will explain the current regulatory regime and assess which categories of illegal internet pharmacies are seemingly obstructed by current measures. Part III will outline some of the primary challenges associated with enforcing the existing regulatory scheme and attempt to explain why enforcement is largely ineffective for the third category of internet pharmacies. Part IV will discuss potential new measures Congress should implement to combat rogue online pharmacies operating domestically or internationally. These recommendations are to A) create a law explicitly criminalizing certain categories of internet pharmacies and imposing severe penalties for violations of that law, B) amend the FDCA by defining valid prescriptions as those requiring in-person evaluations and by increasing statutory maximums so prosecutors will be more inclined to pursue cases against online pharmacy operators, C) develop formal incentives or penalties that encourage private companies to cooperate with law enforcement officials in identifying and tracking illegal online pharmacies, and D) adopt a track-and-trace system to monitor legitimate pharmaceuticals.

1. INTERNET PHARMACY CATEGORIES

   The ability to purchase prescription drugs over the internet provides consumers with substantial benefits including convenience, lower costs, and privacy. (33) In recent decades, however, the internet has provided a way to circumvent traditional methods of obtaining prescription drugs. Whereas patients previously had to make an appointment with a doctor, contact a doctor with whom the patient had an existing relationship, or attempt to purchase drugs illegally, those seeking prescription medications today need to look no further than their personal computers. A simple search such as "Vicodin & no prescription" yields millions of results, thousands of them links to websites that distribute prescription drugs illegally. (34)

   There are three general types of internet pharmacies. (35) First, there are those that dispense or distribute pharmaceuticals to patients bearing legitimate prescriptions. (36) These websites largely comply with the regulatory scheme and operate as mere extensions of traditional brick and mortar pharmacies; they are therefore not the focus of new regulatory efforts. (37)

   Internet pharmacies in the second category ("Category Two") provide prescriptions for customers after an "online consultation." These consultations require a consumer to fill out an online questionnaire which a physician associated with the website "reviews" before prescribing medication an associated pharmacist ships to the customer. (38) Category Two online pharmacies have an aura of legitimacy because they employ licensed practitioners, but are illegal because those practitioners are not practicing medicine according to their professions' accepted standards. Prosecutions against operators of these sites have been largely successful under the Controlled Substances Act (for those selling controlled substances), (39) especially after Congress amended the Controlled Substances Act in 2008 to explicitly prohibit dispensing and distributing controlled substances based solely on an online questionnaire. (40) Clayton Fuchs' conviction is one prominent example of an effective prosecution stemming from this type of internet pharmacy operation.

   The third category ("Category Three") of internet dispensaries is the rogue internet pharmacy. These sites sell drugs to customers without a prescription in direct violation of federal and state law. (41) They may also sell drugs the Food and Drug Administration ("FDA") bans. Many of the sites that continued operating after Congress enacted the Ryan Haight Act fall into this third category because it is more difficult to regulate pharmacies that never purported to comply with the law. (42) These websites allow customers to request their drug of choice, pay by credit card or with cash on delivery, and receive medications without a prescription. When no doctor or pharmacist is associated with the website, no prescription-required drug dispensed is legal, because licensed healthcare practitioners are the only ones authorized to prescribe and dispense pharmaceuticals. These rogue internet pharmacies are largely located abroad and falsely advertise the FDA approves the drugs that they sell. (43) Since government officials have largely claimed success in combating Category Two online pharmacies, (44) law enforcement's current focus has turned to combating this third category of internet pharmacies.

2. THE EXISTING REGULATORY SCHEME

   Prosecutors have multiple existing statutes and regulations at their disposal to use against...