U.S. Food and Drug Administration
FDA has established priorities for taking enforcement actions involving online sales, expanded its capability to monitor violative Internet sites through advanced technology search tools, and established a process to triage and monitor ongoing cases. Using existing resources, through this process, FDA expects to establish a higher profile enforcement presence regarding unlawful online sales.
FDA is working with other Federal agencies and State agencies to better coordinate enforcement efforts. FDA worked closely with the Federal Trade Commission (FTC) in developing the cases announced as part of Operation Cure-All and has been working with the Department of Justice (DOJ) and others regarding online sales issues.
FDA has initiated a series of meetings with state regulatory bodies and other organizations to discuss better ways to regulate online sales.
The types of unlawful conduct involving online drug sales that FDA has identified are similar to unlawful activities that occur in other sales contexts. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, 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; 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 must establish the same elements of a case, bring the same charges, and take the same actions as it would if another medium, such as a storefront or a magazine, had been used.
FDA already has investigated and referred cases for criminal prosecution and civil enforcement actions against some online sellers of drugs and other FDA-regulated products, particularly sellers of drugs not approved by the Agency. FDA intends to significantly expand its enforcement activities regarding online sales. The Office of Regulatory Affairs (ORA) and the Office of Compliance in the Center for Drug Evaluation and Research (CDER) are the primary organizations within FDA with responsibility for regulating online drug sales. These offices review web sites that consumers, industry, health professionals or government personnel report as appearing violative.
Since June 1998, the Agency has taken numerous compliance actions based on violative labeling claims. In at least 27 of these cases, the violative claims had an Internet component. To date, the agency has identified over 60 cases related to suspected illegal Internet sales, with the first Internet prosecution having been undertaken in 1994. Actions included sending warning letters to firms illegally selling unapproved new drugs online and issuing Import Alerts to online sellers of illegal foreign pharmaceuticals. FDA has also contacted web site managers and asked for their voluntary cooperation in removing violative sites. Warning letters to online pharmacies based in foreign countries are shared with the government of that country.
Additionally, CDER's Division of Drug Marketing, Advertising, and Communications has taken steps against online drug promotion that violates the FD&C Act by making unsubstantiated claims or misrepresentations of drugs, or by a lack of fair balance in describing risks and benefits. The Office of Criminal Investigations (OCI) is the entity within FDA responsible for conducting and coordinating investigations of suspected criminal violations of the FD&C Act, the Federal Anti-Tampering Act (FATA), and other statutes including applicable U.S. Criminal Code violations. OCI maintains liaison and cooperative investigative efforts with other Federal, State, Local, and international law enforcement agencies.
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