FDA seeks regulatory role on the Internet

FDA seeks regulatory role on the Internet

House Commerce Committee Chairman Tom Bliley, R-Va., questioned the Food and Drug Administration's effectiveness at regulating online pharmacies by demanding that the agency prove it is using current enforcement tools before asking for expanded authority to monitor Internet drug sales.

"I have become increasingly troubled that the FDA is failing to fulfill its current regulatory obligations," he said in a March 23 letter sent to the agency. "But more troubling, I understand that FDA is drafting a legislative proposal to give itself even more responsibilities under the Federal Food and Drug and Cosmetic Act-in particular, the responsibility to certify all Internet pharmacies."

Bliley specifically wants to know how many enforcement actions the FDA has taken, the details of the agency's newly created Internet Action Plan, and the amount of funding the agency has shifted to Internet enforcement efforts.

The FDA has limited oversight over Internet drug sales since state boards regulate U.S. and foreign pharmacies are out of the agency's regulatory reach. The Clinton administration is asking for $10 million in fiscal 2001 to allow the FDA to monitor online pharmacies.

A House Commerce Committee spokesman said Monday that Bliley's request could generate another hearing on the issue. The committee's Subcommittee on Oversight and Investigations held a hearing last summer.

"We have concerns," the spokesman said. "They're working on legislation to give them more authority and they're not exercising their current obligations. It's ridiculous to through new regulations on top of old."