Has the FDA lost it's mind?>
The FDA Warns Cities, States
About Buying Canadian Drugs
By ANNA WILDE MATHEWS
Staff Reporter of THE WALL STREET JOURNAL
Federal regulators are moving to forestall a drive by some cash-strapped state and city governments to acquire cheaper Canadian pharmaceuticals for their employees.
The Food and Drug Administration wrote to the state of California Tuesday that state, city and county governments that import prescription drugs from Canada will nearly always be in violation of federal law. The agency also said that federal laws pre-empt state, city or county efforts to legalize the importation of drugs from Canada.
"We want to send a very strong message, which is that safety is absolutely crucial, and they need to be aware that these activities are inherently risky," said Peter J. Pitts, associate FDA commissioner for external relations.
In a separate move, the FDA is raising an alarm about a high-profile effort by the city of Springfield, Mass., to encourage its employees to register for a service that offers Canadian drugs to U.S. customers. The FDA investigated the Canadian company that is supplying Springfield's employees, dependents and retirees. Senior FDA officials said the agency plans to follow up with a warning letter to the company, CanaRx Services Inc., informing it that the FDA believes its activities run afoul of American law by sending unapproved drugs to U.S. patients.
Gloria Howard, administrator of CanaRx, said the company hasn't received a warning letter and she had "no response." The company is based in Windsor, Ontario, but maintains a post-office box as a mailing address in Michigan, she said.
Michael Albano, Springfield's mayor, said he remains confident about the safety of the products that he and other city workers are getting through CanaRx. "I'm not going to stop," he said. "It's the right thing to do for my employees and my city." He decided to encourage city employees to use the company to cut the health-care costs for the 20,000 people who participate in Springfield's plan.
The new program, which went into effect July 8, could save the city $4 million to $9 million from a projected $18 million annual pharmaceuticals bill, Mr. Albano estimated. The plan will raise employees' co-payments for U.S. drugs, while charging them nothing for the same products from Canada. The Canadian plan is meant only for drugs taken on an ongoing basis, not for urgent needs such as antibiotics.
The FDA is taking action as more state and local governments are considering such drug imports and some are asking the agency's advice. The possibility of sharply cutting employee drug costs -- Canadian drugs can be one-third to one-half the price of U.S. versions, because of price controls and a favorable exchange rate -- has sparked intense interest among government officials in the U.S.
The agency's letter to California, as well as its move in the Springfield case, might cool officials' eagerness to explore the notion.
"I don't want to do anything that's illegal," said Rolland Grant, mayor of East Providence, R.I. The city of 48,000 has put together a committee to create a Canadian-drug initiative for both its own employees and other residents. Still, Mr. Grant, who decided to look into the idea after reading about the Springfield plan, says he is confident that East Providence can find a legitimate and safe Canadian supplier.
FDA officials, including Commissioner Mark McClellan, repeatedly have raised concerns with Congress about the safety of imported drugs. Lawmakers are expected to debate the issue when Congress returns in September. Currently, it is illegal for anyone but a drug's maker to reimport U.S.-made drugs from abroad, and no drugs are supposed to be used in the U.S. that aren't made in FDA-inspected facilities. Legislation that would allow individuals to acquire drugs from other countries has gained momentum.
Previously, the FDA has tried to get tough on companies that serve as intermediaries in ferrying drug imports to U.S. consumers. In March, the FDA sent a warning letter to Rx Depot Inc., of Tulsa, Okla., stating that its business of helping U.S. citizens purchase medicines from Canada violated federal law. So far, the FDA has steered away from going after consumers who use such intermediaries.
The strongly-worded letter to California officials is the agency's response to questions from the California attorney general's office regarding such plans. The agency said that "almost every time a city, county, or state program imported a drug from Canada, that program would violate" federal law. In addition, "programs that cause illegal shipments also violate" the law.
The agency's concern about Springfield's Canadian supplier sends a message that is likely to stretch beyond the city of 152,000 people. The FDA investigated CanaRx by ordering an insulin product in a sting operation. According to the FDA, the drug, which needed to be chilled, arrived at room temperature, raising a safety issue. Ms. Howard, of CanaRx, said the company's policy is to send drugs that need to be refrigerated by next-day shipment, and keep them chilled during shipment.
Mr. Albano, the Springfield mayor, said he felt the FDA had unfairly focused on his supplier in an attempt to send a message to him and other cities. "Why are they [CanaRx] being singled out all of a sudden?" he said. The mayor plans to meet with FDA officials Sept. 16.
The FDA's Mr. Pitts said: "The mayor of Springfield brought his supplier to our attention. It would have been irresponsible of us not to have investigated."
Mr. Albano received a great deal of attention when he began publicizing his plan several months ago. In a newspaper editorial and national television interviews, he said he had visited CanaRx's facilities, and felt confident enough to use the company to order insulin and other supplies for his diabetic son.
So far, Mr. Albano said, about 700 employees have registered for the Canadian option. Despite the FDA's findings, "We've not had any incidents," he said. |
