Senators demand more regulations on Net pharmacies

Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) and other senators said it was too easy for someone with access to the Internet and a credit card--teenagers, in particular--to buy large quantities of addictive prescription narcotics such as Vicodin and Oxycontin. Leahy cited a 2006 government survey on drug use and health that found about 6 million people currently misuse prescription drugs.

"Dangerous and addictive prescription drugs are too often only a click away without the proper constraints of local doctors and pharmacists," Leahy said at a sparsely attended morning hearing on the topic, which lasted about two hours but was interrupted more than once by floor votes related to the Iraq war.

Members of Congress have been attempting for years to pass legislation aimed at tightening regulations on Internet-based pharmacies. The latest in that crop of bills, introduced in late March by Sens. Dianne Feinstein (D-Calif.) and Jeff Sessions (R-Ala.), would require any pharmacy that wishes to sell controlled substances over the Internet--and is not already registered under existing federal law--to receive authorization to do so from the U.S. attorney general.

But what remains far from clear is whether the law is necessary. Prosecutors apparently have encountered few roadblocks in shutting down "rogue" pharmacies, and the Drug Enforcement Administration has refused to endorse the legislation.

In a case involving United Prescription Services, the DEA used existing law, including its authority to withhold business licenses, to target a pharmacy that primarily did business over the Internet. In another case, called U.S. v. Smith, the government used wire fraud statutes to seek an injunction against online pharmacies that did online consultations instead of face-to-face ones. The Food and Drug Administration also has targeted a company called Wedgewood Pharmacy.

The DEA already has the authority to go after cyber drug dealers--and says it is actively doing so--under an existing federal law called the Controlled Substances Act. The law requires distributors and manufacturers of certain classes of drugs to receive approval from the attorney general before operating. The DEA says that in 2006 alone it coordinated more than 90 Internet investigations, which led to the arrest of approximately 64 individuals and the seizure of about 14 million dosage units of controlled substances.

But the bill's supporters say more regulations are necessary. The legislation, called the Online Pharmacy Consumer Protection Act, would require that such pharmacies fill orders only for people who have presented a "valid prescription" issued by a doctor with whom the patient has a "qualifying medical relationship"--which, for certain classes of drugs, means the doctor has conducted at least one in-person evaluation.

Online pharmacies would also be required to display a statement indicating they complied with state and federal law and to meet all state-level pharmacy licensing requirements. Penalties for more serious violations under the bill would carry up to 20 years in prison and fines of up to $2.5 million.

Blocking Internet sites
At Wednesday's hearing, Leahy suggested Congress may be wise to go beyond that and require Internet service providers to block such sites. He said he believed it would be possible to accomplish that goal without running afoul of First Amendment rights.

Philip Heymann, a Harvard Law School professor who specializes in drug-related legal issues, suggested formulating a group that would monitor for objectionable sites, alert ISPs to their existence, and require ISPs to offer their subscribers the option of having such sites rendered inaccessible from their accounts. (He did not mention that Web-blocking software, which permits end users to block access to designated Web sites, has existed for more than a decade.)

"It is no burden to (the ISPs). They know how to do it; they can do it in a minute," Heymann told the politicians. He also suggested that search engines like Google and Yahoo be required to place banners at the top of their search results pages warning users that it's illegal to buy certain drugs without prescriptions.

Heymann also suggested that ISPs could be forced to filter all Web traffic for specific ads, something that would be technically problematic given the current state of Internet filtering technology. "We believe that Internet service providers should make available to their customers the opportunity to block ads for illegal sales of controlled substances from their Internet service," he wrote in his statement.

Because of the international nature of the Internet, it's not clear how effective any of these proposals would be.

About half of such sites live overseas, according to research described by Joseph Califano, the chairman and president of Columbia University's National Center on Addiction and Substance Abuse. A quarter of them come from the United States, and another quarter of them are of unknown origin, he told the politicians. But not all countries consider such drug sales illegal.

"Obviously we have no control over international pharmacies," Joseph Rannazzisi, deputy assistant administrator for the DEA's Office of Diversion Control, told the politicians.

Gord Haugh, general manager of the Canadian International Pharmacy Association, said the Feinstein-Sessions bill appears to be written with good intentions "because obviously what it's aimed at doing is shutting down some of the bad actors in the business." He said he worried, however, that proposals to block Web sites or crack down on credit card transactions, if interpreted too broadly, could be interpreted in a way that stifles legitimate companies.

"The wording of these kinds of things is critical, obviously," he said in a telephone interview. "There can always be drawbacks...When you try to put a blanket prescription out there to shut down one thing, you often end up with unintended consequences."

CIPA represents about 25 Canadian pharmacies, primarily located in Western Canada, that sell about $500 million in prescription drugs to U.S. customers each year. None of its members ships the subset of prescription drugs known as highly controlled substances, however, because that's already against the law, Haugh said.

Thomas McClellan, executive director of the University of Pennsylvania's Treatment Research Institute, suggested the most effective way to go after such sites is to "follow the money"--that is, to encourage cooperation among credit card companies and banks to pinpoint when dealers are receiving payments and ultimately stop those money flows.

The DEA, for its part, has not yet taken a position on the Feinstein-Sessions bill, which ignited visible frustration from Feinstein during much of Wednesday's hearing.

"We have heard nothing from you, no comment on the bill, which indicates to me that it's an agency that isn't taking this very seriously, to be very candid with you," she told Rannazzisi.

"I take exception to that," he replied. He assured the California senator that his agency has been aggressively using its "regulatory authority" to pursue and shut down domestic Internet pharmacies.

CNET News.com's Declan McCullagh contributed to this report.