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8/23/2000

Clinton Proposes Arming FDA to Fight Illegal Online Sales

Katherine M. Bennett

President Clinton has proposed giving the Food and Drug Administration (FDA) the legal
power to regulate prescription drug sales on the Internet.

  • The plan, announced Dec. 28, calls for legislation that:  Requires online pharmacies, before they start operating, to show FDA they comply with federal and state laws on pharmaceutical sales, 
  •  Increases the maximum penalty—to $500,000 per violation—for selling a prescription drug to a consumer without a valid prescription, and 
  •  Gives FDA the ability to use administrative subpoenas when investigating potentially illegal Internet drug sales.

Also, as part of the 2001 federal budget, Clinton proposed using $10 million to develop a rapid-response team and upgrade FDA's computer technology so the agency can better identify, investigate, and prosecute illegal Web sites. These efforts would be aimed at Web sites that sell prescription drugs without a valid prescription, new drugs not approved by the FDA, counterfeit drugs, and expired or illegally diverted pharmaceuticals.

One part of the plan that started immediately was the FDA's public education campaign. The agency's Web site offers a safety checklist for consumers to use before purchasing prescriptions online. Upcoming projects announced in the plan include advertisements on health-related Web sites and public service announcements for television stations

The requirement for online pharmacies to meet FDA's approval before selling pharmaceuticals, the plan stated, will enable consumers to identify legitimate sites and allow for rapid, coordinated investigations by federal and state agencies. According to the president's proposal, FDA's new authority will not disturb states' regulation of the practice of pharmacy or medicine.

Responses from ASHP and the online-pharmacy community came promptly.

ASHP announced its agreement with the president's call for increasing consumers' protection from the illegal sale of prescription drugs over the Internet. Earlier in December, FDA Commissioner Jane E. Henney had told attendees of ASHP's Midyear Clinical Meeting about her agency's concerns regarding online prescription sales.

Chief executive officers at drugstore.com and HealthCentralRx.com issued statements in favor of Clinton's goal to curtail the operations of illegal online pharmacies. Peter Neupert, at drugstore.com, expressed concern about the proposed legislation's ability to stop existing illegal companies and its power to subpoena records from online pharmacies. At HealthCentralRx.com, Albert Greene pointed out that the proposal does not affect online pharmacies physically located outside the United States.