WASHINGTON — Many say allowing prescription drugs to be imported from countries such as Canada, where government controls set prices low, would help cut down high U.S. prices.
Orrin Hatch says it could also kill U.S. drug safety and research.
"I am far from certain that importation is the magic bullet that will instantly and without repercussions lead to lower drug prices," Hatch, chairman of the U.S. Senate Judiciary Committee, said Wednesday. "I am concerned that importation may eventually provide the bullet in a grand-scale game of pharmaceutical Russian roulette."
The comment came in a hearing by his committee on bills to allow importation. One of the Senate's largest hearing rooms was packed with senior citizens wearing T-shirts and buttons calling for passage. Hatch was among those urging caution.
The Utah Republican worried aloud that allowing importation of drugs whose manufacture and sale are not closely overseen by the U.S. Food and Drug Administration could provide a perfect cover for foreign counterfeits.
Associate FDA Commissioner William K. Hubbard agreed, saying it has found that foreign outlets "may dispense expired, subpotent, contaminated or counterfeit products, the wrong or contraindicated product, an incorrect dose or medication unaccompanied for directions for use."
With that, Hatch said, "It seems that the safety of imported drugs remains in doubt in the minds of experts at FDA and a strong case can be made that Congress would be well-advised to retain the protection" of current law barring importation.
However, Sen. Patrick Leahy, D-Vt., the ranking Democrat on the committee, said, "A prescription drug is neither safe nor effective if you cannot afford to buy it."
Rep. Bernard Sanders, I-Vt., who has led bus trips to Canada for seniors to buy drugs and is a sponsor of one of the bills to allow importation, said the seniors on those trips often buy drugs in Canada for a tenth of the cost of what they would pay in America for drugs often produced at American plants.
"A bus trip across the border is not the way Americans should have to get affordable medicine prescribed by their doctors," Leahy said.
Some groups said the FDA could oversee the safety of such imports. "Although challenging, it can be done," said Elizabeth A. Wennar, president of United Health Alliance in Vermont. "With regard to Canada, it would not be that difficult to do."
She said participating pharmacies could register with the FDA and be given seals for products that comply with U.S. standards. Lack of a seal would prevent delivery.
However, Sen. John Breaux, D-La., said drugs sold from Canada for exportation may come from countries such as Indonesia, Vietnam and Ecuador where safeguards for purity and quality are poor. He said a Congressional Budget Office study also predicts importation would reduce prices by just 1 percent overall in America. That is a high price for counterfeiting and other problems that might come, he added.
Hatch also said that importation "to take advantage of other countries' price controls has other potential repercussions, including the prospect of diminished research into future life-saving treatments" because drug companies could not afford them.
He said it may be wise to address that problem through trade policy and sanctions.
"American taxpayers are putting up $28 billion of their hard-earned dollars this year for biomedical research at the National Institutes of Health while . . . many other countries essentially free-ride on U.S. research and development activities and then set price controls on the approved drugs that are the fruits of this U.S.-financed research," he said. "It is the American taxpayer and consumer that is paying dearly."
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