Post subject: Cyberpharmacies and the role of the US FDA

Cyberpharmacies and the role of the US Food And Drug Administration

Written by Jane E Henney, MD

ABSTRACT

The sale of consumer products over the Internet has grown rapidly, including the sale of drugs. While the growth in online drug sales by reputable pharmacies is a trend that may provide benefits to consumers, online drug sales also present risks to purchasers and some unique challenges to regulators, law enforcement officials and policy makers. The Food and Drug Administration (FDA or the Agency) is concerned about the public health implications of Internet drug sales, and we are responding to these concerns as part of our overall goal of developing and implementing risk-based strategies to protect public health and safety.

Although other products regulated by the Agency, such as medical devices, medical test products, foods, dietary supplements and animal drugs also are sold online, this paper focuses on online drug sales. We discuss the advantages and risks of online drug sales, outline FDA's authority and enforcement activities in this area, and describe new initiatives we are taking to better respond to the regulatory challenges we face.

Benefits of Online Drug Sales

The use of the Internet by our nation's citizens, from school age children to seniors, has opened up vast new opportunities for the exchange of information and for enhancing commerce in all types of consumer products. Electronic mail and chat groups have dramatically facilitated communications. Information gathering that once took hours or days of research, whether for a student's homework assignment or to look up information on the medical condition of a family member, can now be accomplished in minutes.

The Internet is rapidly transforming the way we live, work, and shop in all sectors of the economy. In the health sector, tele-medicine allows people in remote areas to access the expertise of doctors in the nation's finest academic health centers. The Internet permits an increasing number of individuals to obtain a plethora of medical information that often helps them to understand health issues and treatment options. In fact, more than 22 million Americans used the Internet last year to find medical information, either in documentary resources or through online discussions with health professionals. According to Investor's Business Daily, 43 percent of web surfers access health care data online each year. Conducting research regarding their health concerns is the sixth most common reason that people use the Internet, and according to the market research firm, Cyber Dialogue Inc., this number is growing by 70 percent a year.

The increasing recognition of the Internet as a legitimate and important vehicle for drug sales is evidenced by the recent activity of major drugstore companies and Internet retailers in financing, supporting, and sponsoring online pharmaceutical outlets. Last year, for example, CVS Corporation acquired the online pharmaceutical retailer Soma.com and merged the online retail sites of the two companies. We expect this expansion of the online drug sales industry to continue.

Prescription drug sales on the Internet can provide tremendous benefits to consumers. These benefits are many and include: access to drugs for the disabled or otherwise home-bound, for whom a trip to the pharmacy can be difficult; the convenience of shopping 24 hours a day; an almost unlimited number of products for customers; and privacy for those who don't want to discuss their medical condition in a public place. Hyperlinks and search programs provide online customers with written product information and references to other sources of information much more easily than the traditional storefront. Finally, as the use of computer technology to transmit prescriptions from doctors to pharmacies expands, a reduction in prescription errors may be possible.

While online pharmaceutical sales will be important for some customers, it must be noted that the traditional "brick and mortar" pharmacy offers benefits or services that are often not available through the Internet, such as immediate access to prescription drugs needed for immediate treatment. These pharmacies will undoubtedly remain an essential component in the delivery of effective health care.

The challenge for government at both the state and federal level is to pursue policies that will allow legitimate electronic commerce to flourish but provide that safety is assured. Consumers will have confidence in the quality of the medical prescription and in the medicine delivered because the protection for online consumers is equivalent to the safeguards of the traditional local pharmacy and the practice of medicine and pharmacy.

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The original copy of the article is found here(Journal of Medical Internet Research).