Federal Agencies Issue Warnings About Online Rx Sales

The Food and Drug Administration and the Federal Trade Commission told Congress Friday the dangers of drugs over the Internet currently outweigh the benefits, thanks to the proliferation of hundreds of unregulated drug retail sites. In testimony before the House Oversight and Investigations Subcommittee, the FDA’s Dr. Janet Woodcock said “It is not safe right now to purchase drugs online from a pharmacy that is not a well-known entity.”

Jodie Bernstein, director of the FTC’s bureau of consumer protection, echoed that warning. “The current practices of some online pharmacies and of some physicians that provide online prescription services indicate the potential for serious consumer injury.” Bernstein urged the committee to consider whether legislation requiring disclosure of identifying information about the location of a prescription drug web site, online prescribing physicians and online pharmacies is necessary to assist state law enforcement efforts.

Drugstore Cowboys

The FDA, the FTC, the Department of Justice and the state Attorneys General are all investigating various alleged abuses of the Internet to give people access to legal prescription and over-the-counter drugs. According to the committee and several witnesses at the hearing, however, the online pharmacy business lacks one central set of regulations by which consumers can identify safe and unsafe online pharmacists. Regulations vary from state to state, and many online drugstores are bringing in goods from outside the country, where regulations are even more suspect, committee members complained.

Rep. Ron Klink (D-Pennsylvania), ranking member of the oversight and investigations subcommittee, argued that without a system of identifying who the online site operators are, where they are based, where the drugs come from, whether they are licensed, etcetera, consumers are at risk. “There has to be some universal method of dealing with this problem,” he said. “Where does the consumer go to find protection, and if we’re so concerned about not impeding the growth of the Internet, … what about the potential for death from these sales? Who is protecting the American people?”

Klink, who said he plans to introduce a bill after evaluating the hearing testimony and meeting with state authorities, railed against the FDA for not doing enough to police the situation. He and other committee members questioned whether the agency has devoted enough time and personnel to investigate online pharmacies and search for new ones. The FDA responded that it has investigated 104 sites referred by the committee for evaluation and has discovered several hundred more that it is also examining.

According to Dr. Woodcock, the FDA is expanding its surveillance effort by doubling the number of people on that task from 10 to 20 and employing a web crawling program to help scan sites quickly and thoroughly. The FDA also plans to increase its contact with state authorities to track down illegal sales of drugs and other pharmacy products, she said.

At least two of the more prominent online drug retailers say they are ready to cooperate with state and federal officials to police their young industry. PlanetRx.com CEO William Razzouk called for a national summit of online pharmacy companies, regulators and Internet technology companies to improve consumer protection. Such a summit could create “an industry-supported ‘watchdog’ system that would use technology and trained industry experts to seek out and immediately report to regulatory authorities suspected sites that may be selling or prescribing medications without proper licensing,” he told the committee.

Peter Neupert, CEO of drugstore.com argued that safeguards are already in place in the drugstore business, they just have to be applied to online sellers as well. “What’s new here is not the practice of pharmacy, but the way we communicate with and inform customers. Our prescription fulfillment is built on the long standing procedures and infrastructure of walk-in and mail order pharmacies,” Neupert said. “We must be careful to distinguish between safe, legitimate online pharmacies and profiteers using the Internet to engage in illegal activities with willing participants. The most practical approach in differentiating the two is by educating consumers and providing them the tools and means to identify the safe, legitimate online pharmacies.”