Prescription Against Medical TerrorActing Food and Drug Administration Commissioner Lester Crawford has recently expressed concern that terrorists might attack the nation's medicine supply. He's right to alert Americans to this possibility, but his warning merely reinforces the difficulty of ensuring the safety of drugs purchased over the Internet. Before Congress considers drug importation legislation, it should enact stringent measures to protect America's most vulnerable targets – sick children and seniors – from this possible threat.
Robert Goldberg, Ph.D.
August 26, 2004
Commissioner Crawford's warning was far from the first indication of the potential threat. As reported in a congressional hearing held this past March, recovered Al-Qaeda training manuals recommend the sale of counterfeit products to raise funds. Indeed, this April the Bush Administration froze the assets of an individual tied to a Hizbollah ring involved in the manufacture and export of counterfeit pharmaceutical products.
Some in Congress have proposed a technological solution to stem counterfeit and terrorist infiltration. Certainly companies must do more to secure their products and distribution chains. Donald DeKeiffer, a lawyer who consults with drug companies on counterfeiting, notes medicines often have fewer anti-counterfeiting devices than Gucci handbags or Levi jeans. Tamper proof packaging in combination with unique inks, seals and tracing materials, the main proposal, can provide a layer of protection. But according to testimony at a hearing on pharmaceutical security held by the FDA, counterfeiters, because of the declining cost of imaging and graphics technology, almost immediately copy such techniques.
More high tech are recommendations likely to be enacted requiring every case and pallet of medicines to have a radio frequency tag which contains encrypted information about the source, destination and movement of products linked to a secure server operated by a third party. Anyone along the supply chain - the manufacturer, distributor, wholesaler, or retailer - can use the technology to read the data to find out if more than one case has the same code, indicating that one of the cases is a fake. But security experts believe that the system must be in place at first here at home and then throughout the world for it to work. Such a system will require billions of dollars and years of work to become fully operational.
A more immediate way to reduce the terrorist threat, according to William Livingstone, President of Global Options, a security-consulting firm, is cracking down on the Internet sale of prescription drugs. The FDA estimates that half the drugs currently obtained from foreign Internet sites are counterfeit, tainted or outdated. A recent General Accounting Office study confirms that Internet drug purchasing is risky. Nearly half of the drugs purchased by the GAO in its 2004 study – including Canadian websites - were ineffective or potentially dangerous.
But tracking down Internet drug sales is very hard. Over the past decade the FDA, as a recent agency report notes, "has found that many Internet sites are actually comprised of multiple related sites and links, thereby making investigations much more complex and resource intensive. The global nature of the Internet creates special problems for effective law enforcement."
Hence before even considering wider importation of medicines, Congress must target the hiding places and criminal compatriots that allow terrorists to engage in these illegal and deadly transactions. As a recent Washington Post series on drug fraud observed: "Federal prosecutors have shut Web sites, filed indictments and won guilty pleas from several owners. But it often takes years to prove a case. In the meantime, the pills move."
Stopping the flow of illegal drugs through the Internet is difficult because of the global reach of the web. Still, we can insure that American-based operations do not abet this international cabal. Congress must outlaw any Internet pharmacy which does not require a prescription from a doctor unaffiliated with that website who has not actually seen the patient. It should also adopt the recommendation of Senator Charles Schumer to establish a joint US Drug Enforcement Administration (DEA) – FDA task force to monitor website operators and go after illegal ones. And it should let the Treasury Department freeze all the US assets of any individual, company or group indicted for aiding, conspiring or trafficking in illegal Internet drug sales.
Finally, states must shut down unlicensed wholesalers, distributors and repackagers of medicines. Terrorists will seek to exploit soft spots in the distribution chain, and state regulation is one of the softest. As the Post report notes, most of the "counterfeit and mislabeled medication makes its way from the shadow market into the legitimate marketplace" through these unseemly channels. States issue thousands of wholesale drug licenses a year without performing a background or credit check or requiring a hint of record keeping. And the penalties for illegal trafficking are minor. States must raise the standards for the sale and distribution of medicines.
Congress must act to secure the nation's drug supply before it considers importation legislation. Doing anything else ensures that the global drug market becomes a bigger opportunity for terrorists and their allies to profit and poison us with tainted drugs.
Robert Goldberg is Director of the Manhattan Institute's Center for Medical Progress.