Editor’s note: Amalie L. Tuffin is a member of the Research Triangle Park law firm of Daniels Daniels & Verdonik, P.A.Illegal Internet Pharmacies are a major problem

We’ve all seen them, those emails offering us Viagra, Cialis, Oxycontin or other prescription drugs with “no embarrassing doctor’s visits” involved. Most of us just delete these messages as spam. Some people, however, do respond to these emails and purchase prescription drugs, including opiates and other potentially-dangerous medications, from legal and illegal Internet pharmacies.

Dr. Rebecca Patchin, representing the American Medical Association, has stated that “[i]llegal Internet pharmacies and physicians who sell or dispense prescription medication without a prescription — or without a valid patient-physician relationship — are a threat to the public health.” Dr. Patchin went on to note the problems of counterfeit, altered or contaminated drugs being dispensed from such pharmacies, as well as the increased likelihood of prescription-drug abuse in connection.

The abuse of prescription drugs is a major societal problem. On March 1, 2004 the National Drug Control Safety Report was released by the Office of National Drug Control Policy. The report indicated that in 2002 approximately 6.2 million people abused prescription drugs, and that almost 14% of teens between the ages of 12 and 17 had abused prescription drugs at least once. Easy access to these drugs on the Internet has fueled the prescription drug abuse problem.

Congress acts by introducing competing bills

Immediately after the release of the Report, two competing bills addressing the problem of illegal Internet pharmacies were introduced in the House of Representatives. The first bill, the “Prescription Drug Abuse Elimination Act of 2004” introduced on March 2, 2004, is a broad bill aimed at cracking down on the abuse of prescription drugs in a variety of ways, including via increased regulation and oversight of Internet pharmacies.

The second bill, the “Internet Pharmacy Consumer Protection Act” introduced March 3, 2004, is aimed squarely at Internet pharmacies. Both of these bills were submitted to the House Committee on Energy and Commerce, and were referred to the Subcommittee on Health on March 11, 2004.

The Prescription Drug Abuse Elimination Act of 2004

The Prescription Drug Abuse Elimination Act was introduced by Charles Norwood of Georgia, and is co-sponsored by six other representatives. The Internet-pharmacy related provisions of the bill were summed up by Rep. Norwood himself in an article in The Washington Times on March 30, 2004:

“My bill also addresses shortcomings in Internet pharmacies that allow abusers easy access to drugs — sometimes even without a prescription. Under the terms of H.R. 3870, Internet pharmacies would have to meet certain criteria to operate, provide a list of states in which they are authorized to do business, disclose the names of their pharmacists and coordinate closely with the states. Under its provisions, operating an Internet pharmacy without meeting these requirements and others will become a violation of the federal Food, Drug and Cosmetic Act.”

An “Internet pharmacy” is defined as an Internet site that is used primarily to sell prescription drugs in interstate commerce. In addition to the provisions mentioned by Rep. Norwood, the Prescription Drug Abuse Elimination Act contains provisions, applicable to certain drugs covered by the federal Controlled Substances Act (such as opiates, stimulants, depressants, narcotics, etc.), as well as any other drug susceptible to abuse or misuse, that require the verification of prescriptions via direct contact with the treating provider who wrote the prescription.

Further, in order to be a “treating provider” for purposes of the Act the health care provider or one of his or her affiliates must have actually physically examined the patient as well as obtained a patient history. This provision is meant to address the currently-common tactic used by Internet pharmacies of having an in-house physician write prescriptions based on e-mail or telephone interviews and questionnaires rather than actual physical examinations.

The Internet Pharmacy Consumer Protection Act

The Internet Pharmacy Consumer Protection Act was introduced by Rep. Tom Davis of Virginia and is co-sponsored by Rep. Henry Waxman of California. This Act, unlike the Prescription Drug Abuse Elimination Act, is aimed solely at Internet pharmacies. The Internet Pharmacy Consumer Protection Act requires Internet pharmacies to display information identifying the business, physician and pharmacist associated with the website as well as information regarding the states where such persons are authorized by law to prescribe or dispense drugs.

The Act also prohibits websites from referring a customer to a doctor who then writes a prescription without ever seeing the patient. These provisions, though different in detail than the Prescription Drug Abuse Elimination Act, are similar in concept.

The Internet Pharmacy Consumer Protection Act, however, adds a provision that grants states significantly enhanced enforcement powers over Internet pharmacies by giving individual states the ability to take enforcement actions to federal courts in order to shut down an Internet pharmacy throughout the United States, rather than merely within the state in question. This provision allows enforcement resources to be spread much further than they would be if each individual state had to act to shut down each individual illegal Internet pharmacy.

The bills are examples of good government regulation of the Internet as they address significant issues without unduly burdening the growth of e-commerce.

The two bills although differing on the details, each strike a good balance between the competing needs of (i) adequately and responsibly regulating access to prescription drugs that are subject to abuse, and (ii) enabling the continued growth of commerce over the Internet, which has become one of the engines of our economy.

This is true because rather than attempting to enact an outright ban on Internet pharmacies, or the dispensing of certain classes of drugs via Internet pharmacies, the bills simply regulate access to such pharmacies, both doing so in a way which sensibly requires the existence of an appropriate patient-physician relationship as well as increased disclosure by, and supervision of, Internet pharmacies to make sure that they are run in an above-board and safe manner while still providing access to a convenient service to those who legitimately need it.

Daniels Daniels & Verdonik, P.A. has been serving the legal needs of entrepreneurial and high technology clients for more than 20 years. Amalie L. Tuffin concentrates her practice in the representation of entrepreneurial and technology-based businesses, focusing on corporate, taxation and securities matters. Questions or comments can be sent to atuffin@d2vlaw.com