Dr Justina A. Molzon, United States of America
In the United States, more than 22 million people used the Internet last year for medical information. According to Investors Business Daily, 43% of Web surfers access health care data online each year and as many as 50% of the patients in the USA have checked the Internet to find medical information. For the consumers, prescription drug sales on the Internet can provide tremendous benefits, including access to drugs for the disabled or homebound, the convenience of shopping 24 hours a day, privacy and anonymity for those who do not want to discuss their medical condition in a public place, and in some cases, lower prices.
As beneficial as this new technology can be, the Internet also creates a marketplace for activity that is illegal under existing law, such as the sale of unapproved new drugs, sale of prescription drugs without a valid prescription, or marketing of products with fraudulent health claims, as well as bypassing the health professional/patient interaction.
The Food and Drug Administration (FDA) in the USA has the legal authority and responsibility to prevent the importation, sale, and distribution of unapproved new drugs; the importation, sale, or distribution of adulterated, misbranded or counterfeit drugs; the sale or dispensing of prescription drugs without a valid prescription; and the illegal promotion of drugs.
The unique qualities of the Internet, including its broad reach, relative anonymity, and the ease of creating Websites or removing old ones, pose new challenges for the enforcement of existing laws. To address these new challenges, FDA has developed an action plan that defines its mission regarding the regulation of pharmaceutical products sold over the Internet. The goals of the action plan are to ensure that consumers receive FDA-approved products and that online customers are afforded the same protection as traditional consumers, and to encourage consumers to involve their health care professionals in their treatment decisions. In order to implement the action plan, FDA will have to customize and expand enforcement efforts, to identify law enforcement and regulatory partners, to interact with professional organizations, and to engage in public outreach.
The FDA has established enforcement priorities, focusing on unapproved new drugs, health fraud and prescription drugs sold without a valid prescription. By improving our capability to monitor the Internet and to identify potentially violative sites through the use of various search tools, and by upgrading our data handling capabilities, we have improved data acquisition. In addition, a team of representatives from throughout the agency has been set up to prioritize potential cases based on the potential harm to the public posed by the products. This resulted in the evaluation of over 400 Websites for possible regulatory or criminal actions and an increased number of civil and criminal actions. With improved collaboration with International Regulatory Officials, “cyber” letters were also issued. This was the first time the FDA used the Internet to reach those who are potentially violating the Federal Food, Drug, and Cosmetic Act. Cyber letters represent a new stage in the agency’s efforts to protect the public against illegal and potentially dangerous products sold through Websites. The cyber letters explain the statutory provisions that govern interstate commerce of drugs in the United States. The Website operators identified will be warned that future shipments of their products to this country may be automatically detained and subject to refusal of entry.
Hard copies of each cyber letter are sent to the Website operator, the US Customs Service and regulatory officials in the country in which the operator is based. FDA would appreciate it if countries would use their own authority to take action against the operators located in their countries.
In addition to FDA, several Federal and State agencies have a role in regulating online drug sales, so FDA works with the Federal Trade Commission, the United States Department of Justice, the Drug Enforcement Agency, the Federal Bureau of Investigation, the United States Postal Inspection Service, the United States Customs Service, and the state law enforcement agencies.
FDA has also worked with various professional and other organizations to address how best to regulate online drug sales, including the World Health Organization, the American Medical Association, the Federation of State Medical Boards, the National Association of Attorneys General, the American Association of Retired Persons, the National Association of Boards of Pharmacy, the American Pharmaceutical Association, the National Association of Chain Drug Stores, the National Community Pharmacists Association, and the Pharmaceutical Research and Manufacturers of America.
FDA has engaged in an ongoing media campaign and has established a Website that explains the dangers of purchasing drugs online, www.fda.gov/oc/buyonline/default.htm. We have also issued “talk papers” on FDA’s enforcement efforts. We have focused on educating consumers about sites that violate the regulations and we have educated consumers about the dangers of certain products sold via the Internet. We encourage consumers to interact with a health care professional before purchasing products over the Internet. We have also initiated a media campaign about safe ways to purchase pharmaceutical products over the Internet and have established a site where consumers can submit complaints about violative Web sites.