April 9, 2004

BYLINE: By Jonathan Bick; Bick is of counsel to WolfBlock Brach Eichler of Roseland and is an adjunct professor of Internet law at Pace Law School and Rutgers Law School. He is also the author of 101 Things You Need To Know About Internet Law [Random House 2000].

Federal and state governments have insisted that Internet medication sellers must comply with existing laws, including statutes regarding medical devices, medical diagnostics, foods, dietary supplements and animal medications. Nevertheless, medication sales, even prescription medication sales over the Internet, are still lawful.

The major legal difficulty that may arise for an Internet medication buyer is associated with the purchase of controlled substances. Purchasing and having controlled substances shipped to the U.S. is illegal unless the Internet user is registered with the Drug Enforcement Administration as an importer and the Internet user complies with 21 U.S.C. 952. Illegal importation of controlled substances is a felony that may result in imprisonment and fines [21 U.S.C. 960].

An exemption codified by the Controlled Substances Act allows the personal importation of a limited quantity of controlled substances into the U.S. according to 21 U.S.C. 956. This exemption only applies to controlled substances that are carried in for personal use and does not apply to controlled substances being shipped into the United States.

Thus, purchasing controlled substances on the Internet and having them shipped to the U.S. is not permitted by the personal use exemption. Such an Internet medication purchase transaction is normally considered an import of the controlled substance. Accordingly, unless the Internet user is a registered compliant importer, such Internet medication transactions are illegal and subject to seizure.

Internet pharmacists are required to comply with federal and state laws relating to the distribution of medication products. Once a medication has entered interstate commerce, federal law requires all entities that subsequently hold it for sale be in compliance with both the Federal Food, Drug and Cosmetic Act and the Controlled Substances Act.

State statutes also require Internet pharmacists to comply with applicable state laws regulating their practices. In most states, pharmacists are regulated by a pharmacy act in which the legislature creates and empowers a board of pharmacy. The state board of pharmacy promulgates rules and regulations, which it enforces along with the provisions of the appropriate state pharmacy act.

Due to the multijurisdictional nature of the Internet, the purchase and sales of medications via the Internet does not fit well into the standard regulatory scheme under which the federal government regulates the medication product, and under which state governments regulate the disbursement of medications. The Internet's communication features also blurs distinctions between product distribution and the provision of pharmacological related services, and the separate states or countries in which providers and recipients of services are located. It is often difficult to determine which locality has jurisdiction over an Internet medication purchase transaction.

The Internet has transformed American's medication purchasing practices. Millions of Americans use the Internet to purchase prescription medications and lifestyle drugs -- a diverse group of pharmaceuticals that treat the symptoms of normally chronic nonlife-threatening conditions such as hair loss, impotence, obesity or depression.

Real Benefits

Generally, Internet medication purchases follow a three-step process. First, the user opens an account with an Internet pharmacy by e-mailing credit and insurance information to the medication seller. Next, the seller, which is normally licensed to sell medications by the state in which it is physically present, receives a valid prescription for the user. Such a prescription from a doctor can be called, or in some states, e-mailed in.

Upon receipt of the prescription, the Internet medication seller verifies the prescription and dispenses the medication. Some sites require an online consultation with a "virtual doctor" to prescribe a medication. Some online pharmacies send products from a central spot, while others allow users to pick the prescription up at a local drugstore.

Internet pharmacies provide users with a safe, private and convenient way to acquire prescription medications. They provide information on medication interaction, and may e-mail customers if the medication they ordered has been recalled, a cheaper generic version of the medication becomes available, or to remind them of prescription renewals. Most important, they generally sell medications for less than traditional "brick-and mortar" pharmacies.

E-prescription medication sellers provide numerous benefits to customers: they allow people access to medications who otherwise might not have the time or the physical ability to travel to a traditional pharmacy; they provide privacy for those who don't want to discuss their medical needs in a public place; and they use an electronic system that reduces prescription errors.

While no statute exists that outlaws the use of the Internet by a medication seller, the Internet as a communication system may be used in illegal activity, such as the sale of unapproved new medications, prescription medications dispensed without a valid prescription, or products marketed with fraudulent health claims. In short, the Internet sites of legitimate, properly licensed pharmacies provide genuine benefits to consumers while the sites of those engaged in dispensing unlawful prescription medications pose a health and safety threat.

The Food and Drug Administration, using the enforcement powers granted by the Food Drug and Cosmetic Act, investigate and attempt to regulate Internet medication sellers. In particular, the FDA has found that the sale of medications via the Internet is similar to unlawful activities that occur in other contexts.

Under the Food Drug and Cosmetic Act, the FDA has the legal authority to take action against the importation, sale or distribution of an adulterated or misbranded drug; the importation, sale or distribution of an unapproved new drug; the illegal promotion of a drug; the sale or dispensing of a prescription drug without a valid prescription; and the sale of counterfeit drugs.

When any of the aforementioned unlawful activity occurs on the Internet, the FDA works with the Department of Justice to establish the grounds for a case, develops the same charges, and initiates action as it would in a traditional case.

In addition to the FDA, states have enacted laws regulating the sale of drugs. Most relevant to Internet medication sales, many states have laws regarding the sale of a prescription medication that require that a patient be examined by a licensed health care practitioner, who determines the appropriate treatment and issues a prescription for an FDA-approved medication. The patient must then have the prescription filled by a registered pharmacist working in a licensed pharmacy.

Each state has a board of pharmacy that requires pharmacists to be licensed or registered to practice pharmacy. According to the National Association of Boards of Pharmacy, requirements vary among the states, but generally, pharmacists must: have a degree from an accredited college of pharmacy; complete a residency program; pass a licensing examination; and, in most states, meet continuing education requirements.

Legal difficulties arise with respect to Internet medication sellers when a consumer is not examined by a state licensed practitioner prior to purchasing medications via the Internet. While the American Medical Association has stated that a health care practitioner who offers a prescription for a patient he or she has never seen before based solely on an Internet questionnaire generally does not meet the appropriate medical standard of care, such a finding does not make issuing Internet prescriptions without a physical examination illegal.

The enforcement of pharmacy laws by state boards of pharmacy face obstacles when attempting to apply local law to an Internet pharmacy practice located out-of-state. In particular, when a patient in their state is placed at risk of harm by an Internet pharmacy in another state, regulators in both states must cooperate for them to be effective in their joint enforcement. In addition, the ability of businesses to link sites to each other makes it difficult for regulators to know against whom enforcement action should be initiated.

Limited Enforcement

Even in the instances where such action is unlawful, enforcement is limited. Since the doctors associated with the e-medication sellers may or may not be in the same state where the patient lives, states may have trouble prosecuting under their existing criminal and/or consumer protection laws. Only a handful of state legislatures have passed legislation to address issues that arise from Internet prescribing.

Internet medication sales pose additional challenges due to the international nature of the Internet. The most obvious legal difficulty arises from the fact that some medications sold on the Internet may be legal in foreign countries but not approved for use in the U.S., and it is not legal for a foreign pharmacy to ship such medications into the United States.

Although FDA has jurisdiction over a resident in a foreign country who sells in violation of the Food Drug and Cosmetic Act to an American citizen, from a practical standpoint, the agency has a difficult time enforcing the law against foreign sellers. Typically, the FDA's action in this area is to ask the Bureau of Customs and Border Protection to stop the imported drugs at a U.S. port-of-entry.

A retailer of prescription-only pharmaceuticals without prior approval from a license purveyor is a proscribed activity and most clearly violates the Food Drug and Cosmetic Act. Under the act, a drug is classified as prescription-only for one of two reasons: [1] either it is deemed unsafe for use except under the supervision of a state-licensed purveyor, or [2] it is limited to prescription-only use by its approved New Drug Application.

Selling a medication contrary to this prescription requirement is an act that results in the medication being deemed misbranded while held for sale. Internet pharmacy sites that make no attempt to involve a physician in an authorization to dispense prescription-only medications are normally cited for misbranding the product.

The application of the Food Drug and Cosmetic Act is not clear when a prescription-only drug is dispensed pursuant to a physician's authorization that results from the review of an Internet questionnaire filled out by a patient. It can be argued that a physician prescribes based solely on the review of an electronic message from a patient is not a prescription.

This conclusion is based on the belief that there is no legitimate physician-patient relationship. Alternatively, this conclusion is based on the belief that a legal prescription can only spring into existence when a physician has physically examined a patient. If this interpretation is correct, then dispensing pursuant to an invalid physician's order would constitute a misbranding violation as described above.

This argument is rarely sustained. First, traditional prescribing does not require the existence of a physician-patient relationship that meets the aforementioned standards. Doctors regularly call in prescriptions without seeing patients. Second, the expanding use of telemedicine, where physicians and patients may be remote from each other and not personally known to each other, is legally acceptable.

The Food Drug and Cosmetic Act's misbranding provisions require disclosure of information at such a voluminous level that dispensers could not economically comply. However, a specific statutory exemption exists that relieves them of the need for compliance with exhaustive information disclosure requirements. As long as their prescription vial is properly labeled with the patient's name, the prescriber's name and directions for use, according to information provided in the prescription being filled, they are eligible for the exemption. Internet pharmacies generally rely on this exemption.

However, 21 U.S.C.A. 353[b][2] of the Food Drug and Cosmetic Act also states that the exemption from the extensive disclosure requirement does not apply to "any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to a diagnosis by mail." Thus, it may be argued that the term "mail" covers "e-mail" and that an Internet pharmacy that conducts a business of dispensing pursuant to diagnosis by e-mail would lose the exemption, be forced to comply with extensive misbranding provisions that cannot be met and would therefore be in violation of the misbranding section of the act.

Thus, the only clearly compliant Internet pharmaceutical dispensing practices are those that persistently seek proof that the medications they dispense are done so pursuant to prescriptions issued by patients' local physicians. In short, this pharmacy practice model is merely an adaptation of mail-service pharmacies. From a regulatory perspective, there are no critical Food Drug and Cosmetic Act issues for Internet pharmacies that function as mail-service pharmacies.

Less than one year ago, the FDA reported that it had: initiated 372 Internet drug investigations, 90 of which involved domestic Internet pharmacies; helped to effect 150 Internet-related drug arrests, 60 of which involved Internet pharmacy cases, and obtained 92 convictions, 26 of which involve domestic Internet pharmacy cases.

Considering that a recent google.com search for the term "online pharmacy" resulted in more than 4,350,000 hits, the FDA's reported enforcement results look as if they are inconsequential.