Problems Abound With Drug Reimportation
By Liz Goldberg
WASHINGTON, Feb. 16 – The cost of prescription drugs in the United States is too high, but problems, including safety regulation and patent laws, must be ironed out before drugs can be reimported from other countries, said members of the Senate Health, Education, Labor and Pensions Committee and officials who testified at a hearing Wednesday.
The hearing was the first of several the committee will hold to investigate the feasibility of reimporting U.S.-made drugs from other countries. The discussion is coming after a task force researched and identified several challenges facing reimportation.
Many senior citizens and other prescription drug users organize bus trips to Canada to pick up drugs or order them from Canadian online pharmacies. The drugs are available at a fraction of their price in the United States, but many of the pharmacies are reportedly rogue organizations.
“Our seniors are under incredible pressure, and I think this really cries out for action,” Sen. Edward Kennedy (D-Mass.), the committee’s senior Democrat, said of the costs of prescription drugs, adding that lower costs must not reduce safety.
Kennedy noted that the United States invests the most money in developing prescription drugs and also charges the most for the drugs, calling drug costs in other countries “vastly more reasonable” than those in the United States.
Surgeon General Richard Carmona, who led the task force, said the economists and scientists the task force interviewed said the loss of revenue because of drug reimportation programs could deter such research and development in the United States.
Kennedy and several other senators, including Olympia Snowe (R-Maine) and Susan Collins (R-Maine), are co-sponsoring a bill introduced by Sen. Byron Dorgan (D-N.D) last week to allow reimportation of drugs already approved by the Food and Drug Administration (FDA). Sen. Judd Gregg (R-N.H.), who is also a member of the committee but did not attend Wednesday’s hearing, introduced similar legislation on Jan. 26. Collins also co-sponsored his bill. Rep. Jeb Bradley (R-N.H.) introduced a companion bill in the House on Feb. 10.
Although the task force found that Canadian drug regulations are equal to those of the United States, many of the online pharmacies that consumers purchase from are shams, they concluded. The pills they sell could be too strong or too week or have been improperly stored or transported, affecting their “pedigree,” Carmona said.
“The bottom line is that the public can get something that we have no idea if it’s safe or effective,” he said.
Part of the problem with ensuring the safety of reimported drugs is that there are thousands of points of entry around the country through which packages travel each day, Carmona said. The task force recommends a “well-defined, closed system,” with the FDA having authority to monitor all of the packages that come into the country, no matter the original source, he said
Because counterfeiters can duplicate drug labels, seals, watermarks and the shape of pills, the United States needs to develop an electronic system to track and trace packages containing prescription drugs, Carmona said. Such a system would be costly because it would need to stay a step ahead of counterfeiters and would work only if the country exporting the drugs was willing to participate, which few countries are because of the cost, Carmona said.
Loopholes in the way drugs move within the United States also must be closed before drugs are imported from other countries, said John Gray, president and CEO of the Healthcare Distribution Management Association.
Dr. Peter Rost, a vice president of Pfizer Inc., said those loopholes include the thousands of secondary wholesalers of drugs in the United States, which are licensed by states rather than the FDA. Pills also are shipped in large quantities and then repackaged, unlike in Europe, where pills are shipped in individual bottles and are not touched after leaving the manufacturer, said Rost, who told the committee he was speaking as an individual, not as a Pfizer representative.
Two cities in Massachusetts, Boston and Springfield, have relationships with Canadian distributors to import drugs. The state of Minnesota has contractual agreements with reputable Canadian pharmacies and is able to import drugs at lower cost, an arrangement Minnesota Gov. Tim Pawlenty advocates expanding to the entire country.
“We’re asking the government, ideally the FDA . to step in and identify the credible operators” and help the American people get affordable drugs, Pawlenty said, while acknowledging another problem: Canadian companies are already becoming strained by the demand to export drugs to the United States.
Sen. Richard Burr (R-N.C.) expressed additional concerns with Pawlenty’s plan.
“We have a much bigger animal to deal with than what Minnesota has,” he said, referring to the country as a whole.
Burr said reimporting drugs would be a violation of intellectual property laws because the patent owner would have to give approval for the reimportation. Pawlenty said Minnesota imports drugs under a legal provision that allows what might otherwise be a violation of drug companies’ patent rights , but the governor acknowledged that the law would need to be altered if drug importation went nationwide.
Mailing the drugs is also a concern, considering that anthrax and ricin can be mailed, said Burr, chairman of the panel’s Bioterrorism and Public Health Preparedness Subcommittee.
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