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7/23/2004

Feds' Poor Inspections Permit Illegal Drugs to Enter U.S.

Donna Young

The U.S. Customs and Border Protection (CBP) returned about 40,000 packages containing Schedule IV controlled substancesincluding tranquilizers, antidepressants, and painkillersto the original foreign senders in June to reduce a backlog of illegally imported prescription drugs, a congressional investigator told a Senate subcommittee yesterday.

"Tens of thousands" of illegally imported drug products held for inspection at mail or private carrier facilities have also been routinely released by the Food and Drug Administration (FDA) to Americans, said Richard M. Stana, director of homeland security and justice for the Government Accountability Office (GAO)the investigative arm of Congress, which changed its name this month from the General Accounting Office.

FDA complained that processing requirements are too time-consuming, he said, and the agency claims it lacks the resources necessary to examine the packages.

Foreign senders whose packages of illegally imported drugs are returned to them rather than seized have the "complete freedom" to resell those products to Americans, said Senator Norm Coleman (R-Minnesota), chairman of the Governmental Affairs Permanent Subcommittee on Investigations, who described the government's process for inspecting packages and identifying illegally imported drugs as a "crapshoot."

Coleman's remarks came during the second day of a two-part hearing to discuss and examine the extent to which consumers can purchase pharmaceuticals over the Internet without a prescription.

The first hearing was held on June 17, the same day on which GAO released a report that says Americans can easily buy many prescription drug products, including addictive narcotic pain medications, without a prescription over the Internet.

CBP and FDA are responsible for inspecting and interdicting unapproved prescription drugs that are being illegally imported through the mail or private carriers, according to GAO.

CBP inspects packages suspected of containing controlled substances on behalf of the Drug Enforcement Administration (DEA) and can destroy a seized substance or turn it over to other federal law enforcement agencies for further investigation.

Packages that are suspected of containing prescription drugs that are not controlled substances are held for FDA investigators to inspect.

CBP officials have complained that personnel are "tied up processing and not inspecting" because the processing requirements to seize and destroy controlled substances are too burdensome for investigators, Stana said during his testimony before the subcommittee.

CBP's seizure process requires inspectors to record the contents of each packageincluding the types of drugs and the number of tablets, capsules, or vials in each packagebefore it is investigated by Immigration and Customs Enforcement, officially forfeited, and destroyed.

But, Stana charged, when CBP, in an attempt to reduce its backlog, returned to senders packages known to contain controlled substances, investigators missed valuable opportunities to identify the people who may be routinely shipping those products to consumers in the United States and to take those drugs out of the marketplace.

FDA's processing requirements include identifying and measuring the "volumes" of the drugs and entering the information into the agency's database, photographing the products, preparing the medications for temporary storage, and notifying addressees, according to GAO.

Because of statutory requirements, FDA must allow addressees of any package held by the agency the opportunity to present evidence as to why the medication should be admitted into the United States.

Packages of prescription drugs that are not controlled substances cannot be automatically refused and returned to the sender, according to GAO.

If the addressee does not provide evidence that "overcomes the appearance of inadmissibility," the item is refused admission and returned to the sender, Stana said.

But, he noted, because of a lack of inspectors and storage space to hold the increasing volume of suspicious packages, FDA routinely releases packages of illegally imported medications to addresseeseven though those products may pose health risks to consumers.

Coleman asked if giving FDA the ability to seize and destroy packages known to contain illegally imported prescription drugs would solve the problem.

"It would reduce the backlog," Stana replied.

There is not a discrete legal or regulatory prohibition on using the Internet to advertise the illegal sale of controlled substances, said DEA Administrator Karen P. Tandy.

There is also no special DEA registration required for online pharmacies, nor are online pharmacies required to report the nature or volume of their business in controlled substances, she added.

"Such requirements would allow us to identify legitimate online pharmacies and persons operating and promoting them to gather information pointing to patterns of abuse, and to punish rogue online pharmacies," Tandy said.

DEA has 91 active investigations of the diversion of controlled substances involving 537 different Web sites, she told the subcommittee.

"We have shut down 25 Internet pharmacy organizations," Tandy declared. "Over $3.3 million has been forfeited and 3.2 million dosage units seized."

Another $11 million is pending forfeiture, she added.

DEA is "working closely" with other government agencies, the National Association of Boards of Pharmacy, and the Federation of State Medical Boards to "build bridges" with Internet service providers, credit card companies, and private shippers to stop illegal imports of controlled substances to Americans, Tandy said.

The online auction house eBay removed listings of illegal anabolic steroids from its Web site last week after cooperating with DEA, she added.

"The sellers were offering several types of Schedule III anabolic steroids to the highest bidder, which had managed to avoid detection in online filters eBay had set up in cooperation with the DEA," she said. "While eBay, of course, is not an illicit pharmacy Web site, our work demonstrates the successes we have had working with the private sector."

Officials from online search engine giants Yahoo and Google testified that online pharmacies that advertise with their companies must participate in the SquareTrade Licensed Pharmacy program, a verification program of the National Community Pharmacists Association (NCPA) and SquareTrade Inc., a San Francisco online "trust infrastructure" company that provides merchant verification and online dispute-resolution services.

Online pharmacies participating in the SquareTrade program must comply with NCPA standards, said Sheryl Sandberg, vice president of global online sales and operations for Google.

"We recognize that there are bad actors on the Internet, including unlicensed online pharmacies that peddle unsafe and counterfeit products," she said. "We have been working hard to implement policies that will protect our users from encountering these dangerous rogue pharmacies through our advertising services."

Representatives from credit card companies Visa USA and MasterCard International testified that their companies have taken steps to prevent their services from being involved in illicit Internet sales of pharmaceuticals.

"MasterCard deplores the use of its system for any illegal purposes, including for the illegal purchase of pharmaceuticals," said Joshua L. Peirez, senior vice president and assistant general counsel for the company. The company has "shut off" 350 Web sites from accepting MasterCard payment cards "in connection with the illegal sale of pharmaceuticals over the Internet," he said.

Robert A. Bryden, vice president of corporate security for FedEx Corp., testified that his company has package-tracking technology that "can be of significant assistance to law enforcement agencies and we can specifically target packages for inspection that they alert us to."

But, he noted, his company does not have law enforcement authority and does not have available "the intelligence that would allow us to do more than assist law enforcement agencies as requested."

"If we receive information from law enforcement agencies that a particular customer is violating the law, we will assist in the gathering of evidence for the government and we will cease accepting packages from that company," Bryden said.

No Internet pharmacies are authorized to use the FedEx logo to promote their service, he maintained.

But, he added, there are numerous cases where the FedEx brand is used without the company's consent.

"To the extent possible, we are taking appropriate legal action to stop such activity," Bryden said. "Oftentimes, however, the Web site host is several layers removed from the actual shipper utilizing FedEx services, or our logo may appear on the Web site but they may not even be a customer at all."

In most cases, he said, the actual brick-and-mortar address of the Internet Web site is not listed and not available.

"Clearly, individuals who sell illegal drugs do not list their real names and their real addresses on their Web site," Bryden said.