House Panel Releases Study, Holds Hearing on Sales of Counterfeit Prescription Drugs

The House Energy and Commerce Subcommittee on Oversight and Investigations yesterday held a hearing on the rising number of counterfeit prescription drugs entering the United States through the mail and heard testimony from FDA and Bureau of Customs and Border Protection officials about the difficulty of stopping the shipments, USA Today reports. Witnesses testified that illegal drug imports "cannot be quickly destroyed, detained or returned to sender" because of FDA rules. They added that Internet sales of prescription drugs are contributing to the sharp increase in drug imports and that criminals are becoming more involved in selling and distributing counterfeit and adulterated drugs (Appleby, USA Today, 6/25). While federal officials are unable to estimate how many prescription drugs enter the United States illegally, subcommittee Chair Jim Greenwood (R-Pa.) said the growth rate of illegal prescription drug shipments each year could be as much as 1,000% since the subcommittee began investigating illegal drug importation more than two years ago, the Hartford Courant reports. The report found that control over illegally imported drugs has "broken down in Miami," a major port, according to the Courant. Further, Rep. Peter Deutsch (D-Fla.) estimated that as many as 10 million U.S. residents purchase prescription drugs from foreign Internet sites per year. William Hubbard, the FDA's associate commissioner for policy, said that many Internet pharmacies claim that they are shipping drugs from Canada, but the drugs often come from Barbados, India, Russia, the former Soviet republics, Thailand or other developing nations (MacDonald, Hartford Courant, 6/25).

Witnesses testified that FDA and customs officials cannot handle the volume of drugs coming through the mail (Rovner, CongressDaily, 6/24). Hubbard said that while the FDA is "doing what it can" to stop Internet sales and prevent counterfeit prescription drugs from reaching consumers and pharmacies, there is no way for the agency to ensure the safety or effectiveness of imported drugs, USA Today reports (USA Today, 6/25). John Taylor, the FDA's associate commissioner for regulatory affairs, said the agency is "at a loss" on how to prevent counterfeit or unapproved drugs from entering the United States. Taylor added that increasing funding for prevention efforts and package inspection "will not make a dent" because the demand for cheaper imported drugs "is so great," the Courant reports (Hartford Courant, 6/25). However, federal officials this summer will launch a "major operation" to target, examine and test packages for counterfeit prescription drugs and unapproved medications, Elizabeth Durant of the Bureau of Customs and Border Protection said (Schmid, AP/Philadelphia Inquirer, 6/25). The Senate on Friday voted 62-28 to approve a measure that would create a one-year pilot program to allow pharmacists and wholesalers in the United States to reimport drugs from Canada. The Senate approved the measure, sponsored by Sen. Byron Dorgan (D-N.D.), as an amendment to the Medicare reform bill (S 1) (California Healthline, 6/23).