AUSTIN, Texas—Whatever savings may be involved in buying pharmaceuticals across United States borders are not worth the safety risks, says a University of Texas at Austin professor who has testified before Congress twice in the past year on the issue of bringing medicines across borders.
Dr. Marvin Shepherd says he agrees that the nation is facing a health care crisis and that the high cost of pharmaceuticals is one of the biggest problems. But the importation of pharmaceuticals will only add to the country’s health care crisis, he said.
“When you open up the border to importation, it is my contention that you sacrifice safety,” Shepherd said.
“Lack of monitoring and management of products and patient care will actually most likely increase overall costs and contribute to poorer quality of care,” said Shepherd, who addressed concerns of patient safety and lack of control measures.
Shepherd, who has spent the last 10 years researching imported pharmaceutical drug use, testified in Washington July 25 before a subcommittee of the House Energy and Commerce Committee on the issue of drug importation. Last summer, he testified before another House subcommittee.
The bill before Congress would allow importation or re-importation from anywhere in the world as long as the drug “appears” to be approved by the U.S. Federal Drug Administration (FDA) and manufactured properly. Re-importation is exporting the drug out of the country to be sold in a foreign market and then allowing a wholesaler — pharmacy chain or other pharmacy operation — to buy the drug and import it back to the U.S. at a lower cost.
Most of the focus was on prescription drugs from Canada and Mexico entering the United States. Shepherd warned that much more comprehensive research into product quality would be needed.
“There are too many risks for the American public to just open up the border and expect the FDA and U.S. Customs to monitor the situation,” he said. “Many counterfeit drug products fit this criterion of ‘appears.’”
“I can assure you that many of the counterfeit drug products I have seen all ‘appear’ to be the ‘real thing,’” Shepherd said. “Making this determination from world-wide distribution systems of drug manufacturers distributors, shippers, wholesalers and sellers will not be an easy task. Plus, it will be an expensive task.”
Texas has faced the problems of personal drug importation from Mexico for decades, but in the last five to 10 years the practice has escalated, Shepherd said. It is estimated that from 25 to 40 percent of all U.S. residents who travel to Mexico bring back prescription pharmaceutical products.
“With the present bill, I can imagine that a higher proportion of U.S. residents will return with Mexican pharmaceuticals,” Shepherd said. “Some will return with products that are safe, and others will return with products that are not effective or safe.”
Shepherd testified that he does not believe the bill will curtail the number of people going to Mexico because the pharmaceutical product will most likely still be cheaper in Mexico than if the Mexican drug is shipped to the U.S. for sale.
The reasons for the higher costs are associated with assuring quality, re-labeling and profit taking by members of the U.S. distribution system.
“The U.S. distributors of foreign-acquired drug products only have to offer the product at a lower price than what is currently being offered to be competitive,” he said. “In essence, I am not convinced that the savings will be passed on to the consumer.”
The pharmaceutical business in Mexican border towns is a huge tourist attraction and generates hundreds of millions of U.S. dollars to the Mexican economy, Shepherd said.
“The number of Mexican farmacias and mail order drug houses will grow even more with this legislation making access easier and more difficult to control,” said Shepherd. “My major concerns are the lack of medical supervision, the patient’s lack of understanding on how to use the product correctly and the indiscriminate use of products.
“I also have a concern about the assurance of product quality and safety. To me, all of these have a potential to harm, severely injure or kill people.”
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