Elizabeth Durant, executive director of trade programs at US Customs Service testified for the House Commerce Subcommittee on Oversight last Thursday and brought to them the sobering news that over two million packages of prescription medications are being sent into the United States from foreign sources each year. This amount far exceeds the limits of the government's ability to maintain quality control. She estimates that over 90% of the medications that are sent into the United States are not meeting FDA standards.
"Counterfeit pharmaceuticals enter in both wholesale and retail quantities," she testified. "Additional problems include expired materials, products that have not been approved by the FDA for usage, products made in facilities not under proper regulations and products not having the proper usage instructions." The sheer physical load on the FDA to inspect these packages far exceeds their manpower to accomplish the task. A study was recently launched to determine just exactly how far out of control this problem has become and during the five weeks of the study, the Customs Officials flagged 16,000 packages that they felt to be suspicious. Out of that 16,000, less than 2,000 were studied by the FDA - less than 12% of the total amount. FDA Senior Associate Commissioner for Policy, Planning and Legislation William Hubbard also testified saying that, "the tens of thousands of parcels that FDA does not review are eventually released by Customs and sent on to their addressees, even though the products contained in these parcels may appear to violate the FD&CA (Federal Drug & Cosmetics Agency)." The FDA's fault? Not this time.
The sheer volume of the items coming into the United States is beyond what the agency can physically handle. Thus products are coming into the country that are governed by no one, tested by no one and have no guarantee of safety, purity or even of meeting the appropriate shelf life. Could these drugs be well past their expiration date? Absolutely. Durant further testified that, "To offer an example, our seizures included a 3,000 tab shipment of a counterfeit drug with an expiration date of 1980 on it."
Further, and even more distressing, as it proves the severity of the problem, the packages the FDA were able to analyze did prove to be a health and safety issue. It is estimated that 8% of the medications that were checked could not be identified at all due to a lack of a simple label. Another was a medication unapproved and rejected by the FDA and yet another was one that although approved in other countries is not approved in the United States as it "is associated with medically serious gastrointestinal complications." This last quote was from the testimony by Commissioner Hubbard. "Several shipments contained three drugs that were once approved by FDA but have been withdrawn from the market based on serious safety concerns," he further added to the public record.
