Under his new plan, the Food and Drug Administration would oversee Internet drug stores, despite a general reluctance to regulate the Internet in its early stages.
Officials have become increasingly concerned with Internet drug sites, some of which do not verify prescriptions. A 53-year-old man died recently in Chicago after taking Viagra he bought over the Internet. The man never saw a doctor, who could have advised him of the dangers Viagra can hold for those with heart disease.
“Rogue operators pose a threat to the health of Americans,” Clinton said. “Today we are unveiling a proposal that sends a signal that we have zero tolerance for prescription drug Internet sites that ignore federal and state laws and harm patient safety and health.”
Clinton will ask Congress to give the FDA authority to certify and review Web sites that dispense drugs. Each infraction could cost violators a $500,000 fine and the FDA will have new power to subpoena the records of online sites.
Prescription drug sales have traditionally been under the jurisdiction of state government, but over the Internet, a patient can live in one state while the pharmacist lives in a second and the web site operates in a third jurisdiction.
“Many of the traditional safeguards that have been in place for many years are breaking down,” Dr. Jane Henney, FDA commissioner said. “We have to have a way to keep some semblance of a safety net in place.”
Craig Fuller, who’s the new head of the Chain Drug Stores Association said the proposed legislation would put the FDA in an appropriate role.
“We have a safety system in place that protects the quality of the drugs, and the states do, in fact, have responsibility for that in their states. But the Internet goes beyond their states, so there is a necessity here for the FDA to step in,” he said at a press conference today. “The FDA has regularly stepped in where the appropriate system could not be put in place by individual states.”
The initiative includes a request for $10 million next year to hire about 100 investigators and upgrade computers. Like the new laws, new money would have to be approved by Congress.
Even if implemented, it is unclear how these rules would affect Web sites operating out of other countries.