Government to Tighten Rules for Online Prescription Drugs

The White House will announce today the government’s first effort to crack down on the increasingly troublesome, and sometimes illegal, practice of selling prescription drugs on the Internet, senior officials said Monday.

The measures, if approved by Congress, would propel the federal government directly into overseeing the online sale and distribution of pharmaceuticals to individual consumers. The move reflects growing concern within the Clinton administration that the lack of regulation of online pharmacies allows a patient to purchase prescription drugs without first being evaluated by a doctor.

Many pharmacies operating on the Internet take all necessary precautions when dealing with patients electronically, administration officials said. But some “fly-by-night pharmacies” circumvent traditional safety procedures to dispense prescriptions for expensive medications.

The White House plan, which officials said would be included in the annual budget Clinton submits to Congress early next year, would include $10 million to hire an additional 100 staff members at the Food and Drug Administration to carry out inspections and regulation. No more than 50 people are engaged in such work now, FDA officials said.

“It’s not an attack on the Internet or buying prescriptions on the Web,” a senior White House official said. “But it’s a very unregulated area right now and there’s great potential for abuse. We’re targeting the bad apples.”

Under the White House plan, requirements would be established to make sure that online pharmacies comply with state and federal laws. Those requirements would give the federal government a more powerful hand than it has had in the past by, among other things, creating a program to certify that Web sites are operating appropriately and applying federal sanctions against those that do not comply with federal regulations.

In an online purchase, a patient in one state may order drugs manufactured in another and shipped from a warehouse in a third state, with the operation overseen, if at all, by a doctor in a fourth. As a result, individual states are hard pressed to keep track of the sales or to establish jurisdiction.

Although individual drug stores are licensed and regulated by state authorities, state and federal controls of online operations are limited, and violation of federal regulations is considered a misdemeanor punishable by a $1,000 fine. Under the administration’s plan, this would be increased to a $500,000 penalty under civil statutes.

The plan would also include a public education program to make consumers aware of the potential hazards of buying drugs through the Internet.

Jane E. Henney, the commissioner of the Food and Drug Administration, said in an interview that “for this kind of prescribing and dispensing, a new type of safety net needs to be put in place.”

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Times staff writers Alissa J. Rubin and Marlene Cimons contributed to this story.