Policy a prescription for defiance
By SARA FRITZ, Times Staff Writer
Bush administration efforts to dissuade cities and states from buying less expensive drugs in Canada are faltering.
Published December 27, 2003
WASHINGTON - The Bush administration is struggling in its campaign to stop a growing number of cities and states that are considering buying low-price, American-made prescription drugs from Canada.
In recent weeks, Health and Human Services Secretary Tommy Thompson has taken a series of steps aimed at discouraging state and local governments from "reimporting" medicines from Canada for their employees and retirees. Those efforts include:
Numerous meetings in which officials of HHS's Food and Drug Administration have tried to dissuade mayors and governors from pursuing reimportation programs.
Seeking cooperation from credit card companies and major package carriers whose services are being used by Americans who are importing drugs from Canada.
Persuading a federal judge to shut down 85 storefronts in 25 states operated by RxDepot and Rx of Canada to provide consumers with cheaper drugs from Canada.
At least a dozen states, including Illinois, Minnesota and Vermont, as well as the city of Boston are threatening to initiate drug reimportation programs. But only one municipality, Springfield, Mass., has actually implemented such a plan.
So far, neither state nor local governments appear cowed by the FDA's moves to stop them.
"Government is about helping people, and this is an opportunity for the federal government to help the many Americans who use expensive prescription drugs to stay healthy," said Boston Mayor Thomas M. Menino. "The federal government must act now to bring reasonably priced medications to its citizens."
Proponents of reimportation, including both Democrats and Republicans, plan to step up pressure in Congress early next year for legislation that would lift the FDA restrictions.
Although the administration has done nothing until recently to stem the tide of drugs coming from Canada, its response to the states is consistent with its longstanding view that the federal government must halt any distribution of prescription drugs that could jeopardize the safety of Americans.
"There is no evidence that unapproved imported drugs are becoming any safer or more reliable," said FDA Administrator Mark McClellan. "Given FDA's limited resources and authorities to detect and block potentially unsafe imports, we are concerned about any measures that would increase the flow of these unapproved drugs or provide easier channels for them to enter the United States."
Public officials want to buy drugs from Canada because they are cheaper. Because of Canadian price controls, Celebrex, for example, which is used to treat arthritis pain, sells for 79 cents a pill in Canada, compared with $2.22 in the United States. Many states estimate they can cut their spending on drugs in half by buying from pharmacies in Canada.
Several times in recent years, Congress has approved reimportation of drugs from Canada - but only if the FDA certifies it can be done safely. Both the Clinton and Bush administrations, bowing to the wishes of the U.S. drug manufacturers, have declined to make such a certification.
The FDA's opposition to reimportation is based, in part, on a study conducted in early August in cooperation with U.S. Customs and Border Protection. Operating in Miami, New York, San Francisco and Carson, Calif., the government opened numerous packages that appeared to contain prescription drugs. It found many of the drugs were of unknown quality or origin.
FDA officials see this as evidence that reimported drugs are likely to be counterfeit or adulterated. There is no evidence, however, that any American has died as a result of the estimated $600-million in U.S.-made drugs pouring south across the U.S.-Canadian border each year.
At a congressional hearing in November, Sen. Olympia Snowe, R-Maine, called on opponents of reimportation to prove their argument by naming names.
"We have millions of Americans who are now importing drugs," she said. "Name one patient that it has killed, just one?" None of the witnesses knew of any such death.
Democrats in Congress argue that the new Medicare prescription drug bill gives President Bush the authority to assist jurisdictions that want to reimport drugs from Canada. Administration officials disagree.
"Our lawyers are interpreting it differently," said Tom McGinnis, the FDA's director of pharmacy affairs.
He noted the Medicare bill calls on HHS to conduct a one-year feasibility study of reimportation, and he said the administration can do nothing to facilitate reimportation until that study has been completed.
Nevertheless, FDA officials have stopped short of initiating legal action against the city of Springfield, which is reimporting drugs from Canada for about 3,000 city employees and retirees.
The FDA's action in the Springfield case has been indirect. McGinnis said the FDA has asked the Canadian government to stop shipments from a unlicensed pharmacy in that country to Springfield.
In addition, McGinnis said, the FDA is still hoping to persuade Springfield officials to curtail their reimportation program after the current mayor, Michael Albano, leaves office Jan.1.
McGinnis does not rule out suing states and municipalities that initiate reimportation programs. But he said the administration's efforts are aimed at reminding officials that cities and states could be held liable if any patient is hurt by reimported drugs.
That was the message Menino heard when he visited the FDA's Washington offices on Dec.18. He said FDA officials told him that a proposed pilot program to buy drugs from Canada for 7,000 Boston municipal workers and retirees could cost the city more in damages than it saves by buying lower-priced drugs from Canada.
Menino, a Democrat, told the FDA that he intends to proceed with his reimportation plan, beginning next summer, if the federal government does nothing more to bring down rising drug prices.
New Hampshire's Republican Gov. Craig Benson declined a similar invitation to visit the FDA. He is also threatening to begin reimporting drugs from Canada.
The U.S. government can't keep Canadian pharmacies from shipping American-made drugs into the United States, but McGinnis said it will continue to go after pharmacies in the United States that distribute drugs from Canada. That is why the government persuaded U.S. District Judge Claire Eagan on Nov.6 to halt sales by RxDepot and RX of Canada.
The two companies "are able to offer lower prices only because they facilitate illegal activity determined by Congress to harm the public interest," Eagan said.
RxDepot and Rx of Canada have appealed the ruling to the 10th U.S. Circuit Court of Appeals in Denver, but FDA officials have expressed confidence that Eagan's ruling will survive the appeal.
The FDA's request for assistance from Visa USA and Mastercard International as well as a variety of package carriers faces a more uncertain future.
William Hubbard, the FDA's associate commissioner for policy and planning, said the agency wants these companies to alert regulators if they find a pattern of frequent or especially large reimportation shipments. However, he said, this initiative "has not proceeded very far."
Rep. Rahm Emanuel (D-Ill.) says the newly enacted Fair and Accurate Credit Transactions Act, which Bush signed into law on Dec.4, prohibits credit card companies from disclosing medical data on their customers.
"If credit card firms comply with the FDA's request, I believe they would be violating both the letter and spirit of the new law," Emanuel said in a letter to Thompson.
Governors of several states, including Illinois, have asked Thompson to formally waive the restrictions on reimporting drugs from Canada. Thompson, a former governor himself, has been liberal with waivers relieving states of federal obligations under other programs, such as Medicaid. But Thompson has indicated he is not inclined to waive restrictions on Canadian drug shipments.
Meanwhile, as the FDA is getting tough on reimportation, U.S. citizens who are ordering their drugs from Canada have nothing to worry about. "We don't go after individuals," McGinnis said.
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