WASHINGTON -- - The Clinton administration said last week it plans to require Internet pharmacies to be licensed with the federal government and to launch a public education program to warn consumers about the potential hazards of buying drugs on-line.
The initiative -- - the bulk of which requires congressional approval -- - is designed to target the flourishing business of pharmaceuticals sales on the Web and what is perceived as a lot of fly-by-night Internet drug businesses.
Selling pharmaceuticals in cyberspace is now rather freewheeling. Pharmacies in general are required to register in the states they do business in, but because of the elusive nature of on-line sales it's been difficult keeping tabs on what drugs are being sold and whether they are dispensed with a prescription. And since monitoring pharmacies is a state responsibility, the federal government until now has typically taken a hands-off approach to the issue.
John Beckner, director of pharmacy and whole health solutions at Richmond, Va.-based Ukrop's Super Markets, and chairman of the Food Marketing Institute's Pharmacy Services Committee, said federal involvement as a cyber-pharmacy watchdog is needed. About 38% of FMI-member companies have pharmacies.
"Of greatest concern are the illegitimate sites," said Beckner, citing health concerns for consumers who may self-medicate via cyber-drug sales or unwittingly buy unapproved drugs. "Policing from the federal government's perspective is needed and I think most legitimate sites would agree. There have to be some safeguards. There is a lot of potential to create a lot of problems."
Beckner said most supermarkets with pharmacies are starting to explore Internet sales, like Ukrop's, which has 27 stores, 19 of which have pharmacies. He expects the administration's proposed cyber-pharmacy regulations to be heavily debated at an E-commerce session during the FMI's pharmacy committee's April 15 to 18 annual meeting in Phoenix.
Beckner said the proposed federal registration requirements -- - which would include having to be licensed in multiple states since on-line sales often show no boundaries -- - may at first blush appear too cumbersome. However, Beckner said, "you have to start somewhere. All of us want to see the public protected. Most would agree these extra things that might have to be done initially have to be in place."
To bring structure to on-line pharmacy sales, the administration plans to ask Congress to require on-line pharmacies to register with the Food and Drug Administration and to demonstrate they meet all state and federal regulations governing prescription sales. To keep tabs on compliance, the administration is asking for $10 million to hire 100 employees for an Internet pharmacy-policing program to start in 2001.
The money would be used for a special task force to investigate and prosecute Web sites selling drugs without valid prescriptions and drugs that are unapproved by the Food and Drug Administration, expired, counterfeit or illegally diverted. The on-line pharmacy investigators would also check to see if cyber pharmacies are properly registered in the states where they do business. This would include states where customers place orders in addition to the cyber-pharmacy's headquarters.
The administration's plan also calls for creating a new $500,000 civil penalty per violation for selling pharmaceuticals without a doctor's prescription.
According to White House plans announced last week, a separate education program that doesn't require Congressional approval will be launched soon after the first of the year. The campaign will focus on how to buy pharmaceuticals safely over the Internet by detecting illegitimate operations. The public-service announcements will also warn against buying drugs without a doctor's prescription and urge awareness of a drug's side effects if mixed with other pharmaceuticals.
Craig Fuller, president and chief executive officer of the National Association of Chain Drug Stores, Alexandria, Va., said,"Voluntary approaches, coupled with more aggressive enforcement of the regulatory mechanisms already in place and currently available to the FDA, individual state boards of pharmacy and state boards of medicine, if more fully utilized, are adequate to protect consumers."