WASHINGTON - Foreign Internet pharmacies shipped counterfeit Viagra impotence pills and OxyContin painkillers to the United States, according to a report requested by Republican Sen. Norm Coleman.
The General Accounting Office, Congress' investigative arm, found substitutions for Pfizer Inc.'s Viagra, Purdue Pharma Inc.'s OxyContin and Roche Holding AG's Accutane. Forty-five of 68 pharmacies in the United States, Canada and 10 other nations also sold prescription drugs without a doctor's order.
Coleman, of Minnesota, heads a panel that heard testimony yesterday on the safety of imported medicines. He supports one of three Senate proposals that would allow Americans to buy cheaper drugs from countries outside the United States. Drugmakers, such as Pfizer Inc., and the United States government have opposed the practice, citing safety concerns, including contamination and improper storage.
"We observed questionable characteristics and business practices of some of the Internet pharmacies from which we received drugs," the GAO report said. "Most, but not all, involved other foreign pharmacies" outside Canada and the United States.
An unspecified number of Internet pharmacies investigated medicines improperly sent to patients who should be monitored by a doctor when they are taking the drugs, the study found.
Washington-based AARP, the largest lobbying group for seniors, said it plans to mobilize its 36 million members age 50 and older to overcome opposition by pharmaceutical companies to such drug imports. U.S. consumers spent more than $1 billion last year on medicines from Canada, where regulations keep prices as much as 70 percent below those in the United States.
"We know we have no shortage of access to drugs from countries all across the world," Coleman said at the hearing. "What we really need is a national strategy for separating out drugs that can heal from drugs that can kill and determining what our best options are for regulating Internet pharmacies."
Shares of Pfizer gained 5 cents to close at $35.27 yesterday on the New York Stock Exchange. Roche's U.S. shares added 45 cents to $103.05.
States such as Minnesota, Wisconsin, New Hampshire, North Dakota, Iowa and Illinois are studying ways to reduce drug spending by purchasing drugs from Canada. Springfield, Mass., said it saved $2.8 million in the past year by buying from Canada for its workers and pensioners.
In April, the Wisconsin Department of Health and Family Services told three Canadian Internet pharmacies that they had violated terms of an agreement to ship only United States-approved drugs, the U.S. Food and Drug Administration said yesterday. The medicines had been approved in Canada.
In its report, the congressional accounting office said it found that 16 of 18 drugs that investigators bought from Canadian pharmacies weren't approved for sale in the United States, but all of them were chemically comparable.
Investigators also obtained drugs from Argentina, Costa Rica, Fiji, India, Mexico, Pakistan, the Philippines, Spain, Thailand and Turkey, the report said.
"Obtaining a drug from many of these pharmacies involved only selecting the desired medication and submitting the necessary billing and shipping information," the report said. "It is notable that we identified these numerous problems despite the relatively small number of drugs we purchased."
Two cases cited in the GAO report involved Viagra, the impotence medication sold by New York-based Pfizer, the world's biggest drug maker, the GAO said. Another substitute was made for Oxycontin, a drug produced by privately-held, Stamford, Conn.-based Purdue Parma. The fourth medicine involved was Basel, Switzerland-based Roche's Accutane.
In addition, the inquiry found drugs with restrictions were sold to customers. Accutane carries a risk of stillbirths or deformities for pregnant women.
In a response included in the study, the FDA urged a broader sampling of Internet pharmacy practices. The agency's acting commissioner, Lester Crawford, said in a May 26 interview that regulators can't ensure the safety of unauthorized drug imports.
"Although the size of the study demonstrates the gravity of the situation regarding other foreign Internet sites, a much larger study that has statistical significance should be considered," the FDA said.
The GAO said it found that pharmacies that advertised painkillers known to cause addiction tried to fill orders with less potent and addictive medications. One U.S. pharmacy declined to fill an order for Accutane. The FDA and Roche have a program in the United States to limit use of the drug to people whose doctors have informed them of its risks.
One Canadian and one U.S. pharmacy declined to fill an order for Basel, Switzerland-based Novartis AG's Clozaril schizophrenia drug, the study said. The medicine can cause a fatal blood disorder, and patients should be monitored by doctors.
