Consumers Still Buying Risky Imported Drugs Online: FDA

THURSDAY Nov. 1, 2007 -- Many Americans are buying drugs over the Internet from foreign countries in an apparent effort to avoid the need for a prescription, U.S. health officials said Thursday.

But many of these drugs are unregulated, posing a health risk to purchasers, the officials said.

Also, despite the widespread belief that many imported drugs cost less than those available in the United States, the medicines from abroad have generic equivalents that would cost American consumers less money, U.S. Food and Drug Administration officials said.

During a year-long investigation of imported drugs, the FDA said it found that 88 percent of the 2,069 drug packages it examined appeared to be prescription medicines also available in the United States. The other 12 percent were dietary supplements, foreign products with labeling that was illegible or incomprehensible, and medications not available in the United States.

"The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor, since these Web sites typically do not require the purchaser to have a prescription," Randall Lutter, the FDA's deputy commissioner for policy, said in a prepared statement. "In essence, they seem to be getting and using prescription drugs without a prescription, an intrinsically risky practice."

The agency said it also found that 53 percent of the drugs sampled have FDA-approved generic equivalents. The agency also noted that earlier studies had found that generic drugs in the United States were cheaper than comparable drugs in Canada or western Europe.

Forty-seven percent of the approved generic versions of the drugs the agency sampled can be bought for $4 at several national chain pharmacies. That price is often lower than the shipping costs for the same foreign drugs bought online, the FDA said.

The FDA collected its data from September 2006 to August 2007 in international mail facilities and courier facilities across the country.

While Web sites can appear legitimate, they can be fronts for illegal operations, the FDA said. The agency urges consumers to be wary of unregulated Internet drug sellers, because "many of their products may not contain the correct ingredients and could contain toxic substances."

The FDA said that some imported drugs it found need special monitoring by physicians to guard against potential adverse events and to ensure effectiveness. These included antibiotics, antidepressants, the blood thinner warfarin, and the drug levothyroxine, a thyroid replacement hormone.

Sharon Treat is executive director of the National Legislative Association on Prescription Drug Prices, founded by state legislators to work jointly across the country to make prescription drugs more affordable and accessible to consumers. Treat said that, rather than discouraging the importation of drugs, the federal government should develop a system that guarantees their safety.

"If the Congress would pass, and the president wouldn't veto, legislation to authorize the importation in a system that involves safety checks, we would be in much better shape than we are today, because consumers would have less expensive drugs, and there would be a system to make sure that the drugs that they are purchasing are safe," she said.

Treat said there are safe ways to buy drugs over the Internet, but there are also sites that aren't on the "up and up."

"But, because many people do not have any prescription drug coverage at all, they are going to do whatever they can to find medicines they can afford," she added.

Another expert thinks that there are legitimate concerns about buying drugs online, but that buying drugs with a prescription from pharmacies in Canada is usually safe.

"Most people who are taking buses from Vermont and New Hampshire to Canadian cities or buy online are doing it to save money, and they know the drugs they are going to get are identical to the ones they get in the United States, except it costs less," said Dr. Sidney M. Wolfe, the director of the Health Research Group of Public Citizen.

"That's not to say there is no safety issue," Wolfe added. "But the main underlying concern of the industry is that they don't want people buying drugs at a lower price than they can buy them in this country. The FDA is using a fear tactic, which belies that the drugs you buy in Canada over the Internet are the same as the drugs you buy here."

Also Thursday, a Congressional committee began a hearing into what some lawmakers said was a lack of supervision of drugs manufactured abroad and shipped into the United States.

Two-thirds of the foreign drug manufacturers subject to inspection by the FDA may never have been visited by agency inspectors, a government watchdog reported to the House of Representatives Energy and Commerce subcommittee on oversight and investigations, according to the Associated Press.

This year, the FDA listed 3,249 foreign pharmaceutical manufacturers subject to its inspection, but the agency can't determine whether it has ever inspected 2,133 of them, according to a Government Accountability Office report released during the hearing.

While some of the more than 3,000 firms may never have exported prescription drugs or drug ingredients to the United States, others likely have, the report said, according to the AP.

FDA Commissioner Dr. Andrew von Eschenbach said the issue was larger than just one of inspection numbers.

"The solution to ensuring the quality of imports does not rely solely on increasing the number of inspections we conduct abroad -- or even at the border," von Eschenbach said. He said the FDA is looking to revamp its whole import strategy to ensure that quality is built into agency-regulated products from the start. He also proposed posting FDA employees abroad, where they could help build up the agency's foreign counterparts, the AP said.

More information

For more on the risks involved with buying imported drugs over the Internet, visit the U.S. Food and Drug Administration.

Posted: November 2007


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