Beyond the neighborhood drugstore: U.S. regulation of online prescription drug sales by foreign businesses.

• Author: Gomez, Ivette P.

1. INTRODUCTION

   Drugstore.com, cvs.com, and walgreens.com are just some of the more than 400 known e-commerce businesses that dispense prescription drugs online. (1) A study of websites maintained by pharmaceutical companies conducted in mid-1997 forecasted the huge growth in this area of e-commerce. (2) For the most part, consumers obtain their medications from these pharmaceutical websites by mailing in prescriptions to them or by having their physicians phone-in prescriptions to the service provider. (3) Cvs.com, for example, specifies on its website that it will only fill prescriptions written by a licensed physician, and that it verifies all prescriptions with the customer's doctor. (4)

   Many of these legitimate online pharmacies received pharmaceutical industry approval for their adherence to United States Federal Food and Drug Administration regulations. (5) The National Association of Boards of Pharmacy (NABP), which assists state licensing boards in pharmaceutical industry regulation, established the Verified Internet Pharmacy Practice Sites (VIPPS) program, which assigns a seal of approval to websites that meet NABP standards. (6) To date, several websites have been commended for their compliance under NABP and have received the seal of approval, including drugstore.com. (7) Moreover, these companies not only legitimately provide prescription medications for consumers, but they are also very lucrative businesses, with projected sales reaching $15 billion by 2004. (8)

   Lurking in the shadows of these legitimate online pharmacies, however, are less-than-scrupulous websites, many based outside of the United States (9), which fill drug orders for consumers without medical prescriptions, (10) administer pharmaceuticals that do not have FDA approval, (11) provide medications that fall below the recommended dosage and potency levels, (12) and deceive consumers with the promise of miracle cures. (13) Referred to as "rogue" online pharmacies, (14) these sites greatly outnumber the legitimate online pharmacies--400 to 6 by estimates made in 2000. (15) Some internationally based web sites only require consumers to complete an order form and select a drug and quantity, (16) while others require consumers to fill out a questionnaire about their health without a medical opinion prior to the sale of the prescription drugs. (17)

   Categorically, online pharmacies fall into four types:

   "[1] online pharmacies that are partners with traditional brick and mortar pharmacies ... ; [2] online pharmacies that are themselves brick and mortar pharmacies ... ; [3] online pharmacies that operate solely on the Internet ... ; and [4] websites, usually based outside of the United States, where consumers can order prescription drugs without a prescription...." (18) Typically, ordering from an online pharmacy requires a consumer to submit a written prescription, or at the very least requires a telephone conversation between the online business and the prescribing physician. (19) Not so in the case of the rogue pharmacies, or websites posing as such, particularly those based abroad. A survey of more than 2,000 online pharmacy services conducted in the year 2000 revealed that eighteen percent were based internationally, (20) as is the case of viagra-global.com. For instance, a disclaimer on the site holds the consumer responsible for knowing the health risks from using Viagra and claims that the online business is not liable in any way. (21) Furthermore, under its shipping policies, viagraglobal.com states that consumers are responsible for compliance with all laws that may affect them, "[e]specially relating to the importation and the use of Viagra." (22) Nothing on the site indicates the country of origin, or the address of the business, although prices are quoted in both dollars and the English pound. (23)

   Ordering medications on-line is appealing to many consumers because the Internet provides a cheap alternative to purchasing at regular brick-and-mortar establishments. For example, prescription drug prices in the United States are four times as expensive as in Mexico, and twice as much as in Canada or the European Union. (24) Meanwhile, prescription drug costs in the United States are rising at a rate of eighteen to twenty percent per year. (25) A 2001 Internet survey of more than 3,000 Web users (26) revealed that 86 percent used the Internet to get information about pharmaceutical drugs. (27) A similar survey conducted in 1999 more closely studied participants' drug purchases on the Internet, and found that 16 percent of all respondents claimed to buy drugs on the Internet, 8 percent of those specifying that they purchased prescription medications online. (28) Of those numbers, 18 percent were North Americans and ten percent from Europe. (29) The foundation has the support of organizations worldwide. (30)

   This note seeks to examine the legal and regulatory implications of the purchase of prescription drugs from international online pharmacies such as viagra-global.com. An analysis of current regulatory schemes, proposed legislation, and worldwide efforts in this area will also be discussed.

   Part I will discuss measures already taken by the FDA, the United States Congress, the domestic pharmaceutical industry, the United States Customs Agency, and state law enforcement agencies to address the issues of importation of pharmaceuticals (31) purchased from international online websites. This section will also review proposed legislation aimed at regulation and enforcement in this new sector and the implementation of guidelines to ensure better consumer knowledge. Part II will take a similar analytical approach, but will focus on how other foreign countries deal with the same regulation and enforcement issues, in particular the European Union.

   This paper's ultimate conclusion is that a balance must be struck between protecting the public health and safety, and providing consumers with choices that only a global market can offer. Though the need to regulate the inflow of medicines (especially those purchased and sold without a prescription) from the rogue online pharmacies is apparent, benefits such as privacy, (32) convenience, (33) and cost savings (34) offered by responsible websites should be safeguarded. While the United States should continue in its efforts to regulate the new industry, it would be apt to take heed from its European counterparts. And moreover, as Jane E. Henney, M.D., former Commissioner of Food and Drugs for the Food and Drug Administration, under the Clinton Administration, stated in her testimony before the Senate Committee on Health, Education, Labor and Pensions on March 21, 2000, consistent principles, both nationally and internationally, need to be implemented in order to lead to more safe and predictable results when dealing with online pharmacies. (35)

2. THE UNITED STATES BATTLES INTERNATIONAL ONLINE PHARMACIES

   1. Regulations Now In Place

      What was touted as "the first-ever bust of online pharmaceutical peddlers" by United States Customs occurred in March of 2000 in Thailand and resulted in 22 arrests. (36) In 1999, U.S. Customs seized 4.5 times as many illegal drugs from outside of the United States than it did the previous year. (37)

      The FDA is the main federal regulatory agency that oversees the manufacture and importation of drugs into the United States. (38) Under the Federal Food, Drug, and Cosmetic (FD&C) Act, the FDA can take legal action against "the importation, sale, or distribution of an adulterated or misbranded drug; the importation, sale, or distribution of an unapproved new drug; illegal promotion of a drug; the sale or dispensing of a prescription drug without a valid prescription; and counterfeit drugs." (39) The import of drugs that have never been FDA-approved and unapproved foreign-made versions of FDA-approved drugs are also prohibited. (40) When the Internet is used as a tool for selling illegal drugs (that is, prescription drugs not approved by the FDA), the FDA, together with the Department of Justice, treat the development of charges and evidence, and the prosecution, just as they would if the drugs were illegally sold in a store or in a magazine. (41)

      In July 1999, the FDA adopted an Internet Drug Sales Action Plan to address the issue of illegal sales of prescription drugs over the Internet. (42) The FDA estimates that approximately 2 million packages containing products, including prescription drugs, that are illegal under the FD&C enter the United States yearly. (43) Goals of the plan are public outreach efforts, outreach and partnering with health professionals, and coordinating efforts with other state and federal agencies. (44) The public outreach program includes providing information about purchasing drugs online in the FDA Consumer magazine and on the FDA website, (45) and providing a medium for consumer complaints or information on rogue sites. (46) In 2000, the Agency launched a new media campaign about safe ways to purchase pharmaceutical products over the Internet. (47) Under its cooperative efforts with other agencies, the FDA has created partnership agreements with the National Association of Boards of Pharmacies and the Federation of State Medical Boards. (48) The FDA also has worked in conjunction with the National Association of Attorneys General. (49)

      The FDA's efforts to combat importation of products from foreign pharmaceutical websites are strongest where it is cooperating with other federal agencies and those in the international arena. (50) The Agency has worked domestically with the Department of Justice (DOJ), including the Drug Enforcement Administration (DEA) and the Federal Bureau of Investigation (FBI), the U.S. Customs Service (Customs), and the Postal Inspection Service. (51)

      In June 1999, the FDA established a case evaluation program with the Office of Enforcement and the FDA's Office of Criminal Investigations (OCI), along with the...