Fake drugs, real worries
High prices and the Internet are making U.S. patients easy prey
Overwhelmed inspectors. In one of the larger mail facilities, in one week, customs collected 16 large bins of about 3,000 packages suspected to contain counterfeit or unapproved drugs for the FDA to inspect. FDA officials, however, estimated that it would take them a week to open and fully inspect about 140 of those packages. The FDA has fewer than 100 investigators to deal with drug importation issues nationwide. So the agency employs a "risk assessment" approach and tries to target particular countries, export companies, or packages suspected to contain certain drugs. The rest the FDA releases back to customs, which sends them on to the addressee "even though the products contained in these parcels may violate the Food, Drug, and Cosmetic Act and may pose a health risk to consumers," the FDA's Hubbard told a House committee last year. "We acknowledge that this is not an optimal public-health outcome . . . ."
As far as what's really in those packages, analyses by customs, the General Accountability Office, and FDA inspectors offer some disturbing snapshots. The customs lab analysis showed that of 180 drug samples, the majority, 67 percent, either were never approved by the FDA or had been withdrawn from the U.S. market for safety reasons. Five percent contained no active ingredients at all. And 28 percent contained controlled substances prohibited from importation.
Despite the limitations, the FDA, customs, DEA, and local law enforcement agencies working together have cleaned up a number of major counterfeit scams. In February 2004, the FDA shut down an Internet site called www.rxpharmacy for selling counterfeit contraceptive patches to unsuspecting women. The patches appeared to be Ortho Evra, a transdermal contraceptive made by Ortho-McNeil Pharmaceuticals. A week later three sites offering "FDA-approved drugs" were shut down for shipping unapproved products.
In Florida, where a grand jury was impaneled to investigate the avalanche of counterfeit and unapproved drugs moving through the state's healthcare system, FDA and local officials uncovered a scheme to sell millions in fake HIV and cancer drugs. By relabeling 110,000 bottles of a lower-strength medicine as high-strength Procrit, the counterfeiters passed the "Procrit" through four states and a variety of wholesalers until investigators located 800 boxes of the stuff in the warehouse of a large Texas wholesaler. Fewer than 10 percent were left. It's estimated that counterfeiters made about $46 million selling the "Procrit" to unsuspecting patients.
Paul and Cindy Dumas still don't know how they got the fake Lipitor, but the FDA arrested a counterfeiter in the case last summer. A Costa Rican man imported the "Lipitor" to the United States in bottles listed as destined for export to another country. Once here, the bottles were emptied of the fake "Lipitor," filled with another product, and exported. The "Lipitor" was sold to brokers, small wholesalers, and various "repackagers" before it was distributed to licensed retail and Internet pharmacies. Authorities continue to follow the trail, and Dumas is angry that he still doesn't know what he took for two months. He did find out shortly after the fake-drug incident that his cholesterol had gone up.