The U.S. FDA is concerned about the proliferation of sites that substitute a simple online questionnaire for a face-to-face examination and patient supervision by a health care practitioner. According to the American Medical Association, a health care practitioner who offers a prescription for a patient he or she has never seen before, based solely on an online questionnaire, generally does not meet the appropriate medical standard of care.

The Agency is equally concerned that in some Internet transactions there is an apparent absence of any health professional/patient relationship. This is a particular concern where a patient may be using a prescription drug for the first time or where the patient may be taking other medications. FDA is concerned that the selection of prescription drug products or treatment regimens for a particular patient should be made with the advice of a licensed health care practitioner who is familiar with the patient’s current health status and past medical history. In situations where a customary physician-patient relationship does not exist, the patient may be practicing what amounts to self-diagnosis.

Legitimate sites dispense drugs based on valid prescriptions. Consumers can check with their State Board of Pharmacy or the National Association of Boards of Pharmacy to see if the online pharmacy possesses a valid pharmacy license and has met state quality standards. One means that consumers have at their disposal to protect themselves is the Verified Internet Pharmacy Practice Sites, or VIPPS system, developed by the National Association of Boards of Pharmacy (NABP) in choosing online pharmacies with which to do business.

This program, which verifies the legitimacy of Internet sites dispensing prescription drugs, provides a “seal of approval” to sites that apply and meet state licensure requirements and NABP’s standards. Although participation in the VIPPS program is voluntary, the Agency believes this program is an example of one that is very helpful in assuring consumers that the Internet site they are using is reputable.

Illegal online drug sales are meant to bypass regulation. The unique qualities of the Internet, including its broad reach, relative anonymity, and ease of creating new or removing old websites, pose new challenges for the enforcement of the Federal Food, Drug, and Cosmetic (FD&C) Act and state laws regulating the practice of medicine and the practice of pharmacy. FDA has found that many Internet sites are actually comprised of multiple related sites and links, thereby making investigations much more complex and resource intensive.

The global nature of the Internet creates special problems for effective law enforcement. Different approaches to drug approval and marketing in foreign countries further complicate law enforcement issues for U.S. officials. FDA and other U.S. government agencies must try to work with foreign governments to share information and to develop mechanisms for cooperative law enforcement, but this is a difficult task.

According to the FDA, the types of unlawful conduct that can occur when drugs are sold over the Internet are similar to unlawful activities that occur in other contexts. Under the FD&C Act, FDA has the legal authority to take action against: the sale, distribution or importation of an adulterated or misbranded drug; the sale, distribution or importation 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.

When the Internet is used for an illegal sale, FDA, working with the Department of Justice (DoJ), must establish the grounds for a case, develop the same charges, and take the same actions as it would if another sales medium, such as a storefront or a magazine, had been used. FDA has investigated and referred numerous cases for criminal prosecution and initiated civil enforcement actions against online sellers of drugs and other FDA-regulated products, particularly sellers of drugs not approved by the Agency.

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Via US FDA