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FDA drug scrutiny rapped as uneven

The Food and Drug Administration is serious about monitoring the safety of mail-order drug shipments in the United States -- if they come from Canada.

Last month, the agency conducted an unusual sting operation targeting the City of Springfield, which is importing lower-priced drugs from Canada for city workers to reduce the spiraling cost of drugs bought in the United States. In an elaborate undercover operation, the FDA received at room temperature a single order of insulin that should have been chilled. The agency publicized the sting nationally to illustrate what it described as the dangers of ordering drugs by Internet from Canada.

But the FDA takes a hands-off approach to enforcing the much greater volume of prescription shipments from US Internet mail-order pharmacies, where increasing numbers of Americans get their drugs. In fact, FDA officials said they can't recall ever conducting a domestic sting operation targeting the quality of insulin or other drug shipments.

Critics said the agency is in the pocket of US drug makers, which have vigorously tried to shut down Canadian imports.

"I'm very concerned that they are selectively enforcing here," said Springfield Mayor Michael Albano, who is heading to Washington for meetings today with FDA officials to make his case. "They're doing the pharmaceutical companies' bidding to try and stop the momentum."

Though rising, Canadian drug imports totaled just $700 million last year. In comparison, Americans buy that amount of drugs every 10 days from domestic mail-order prescription businesses, and the level is growing fast.

Meanwhile, there are concerns that the lack of FDA oversight of US shipments is a problem. According to a study using dummy packages with temperature sensors sent to 32 states, one in four mail-order prescription deliveries in the US is likely to be exposed to "excessive heat" while en route to the consumer. In some cases, especially with biologic drugs, excessive heat can diminish the drugs' effectiveness.

The study was conducted by US Pharmacopeia, a Rockville, Md., nonprofit group that sets national standards for pharmacies. The group has encountered industry resistance to spending on new technology to ensure safer deliveries.

"I have never, ever had insulin arrive cool in 13 years of buying it" through domestic mail order, said diabetes patient Tom Boyer of San Francisco. He throws the lukewarm cold packs that arrive with his 90-day insulin supplies into the freezer. When they get cold again, he uses them to soothe a sore knee.

Independent US Representative Bernard Sanders of Vermont, who advocates legislation to allow the importation of low-cost Canadian drugs, said the Springfield sting and lack of US enforcement are evidence that the FDA is helping drug companies protect higher drug prices paid by American consumers.

"The FDA is working for the pharmaceutical industry, which contributes huge amounts of money to the Republican Party and the president," Sanders said.

The FDA declined to respond specifically to charges that the agency favors industry.

"Our policy is based on promoting the safety of the American people," said Brad Stone, an agency spokesman in Washington. William Hubbard, the FDA's associate commissioner for policy and planning, said the Springfield sting was necessary because there are no other mechanisms to hold Canadian companies accountable.

Hubbard said the FDA "absolutely" has the jurisdiction to regulate the safety of domestic mail-order shipments. But he said enforcement at the state level ensures that consumers are protected.

"No American pharmacist is going to give you hot insulin," he said. "He's going to be subject to licensure, subject to inspection, subject to a complaint from a patient. His business is going to be at risk. This guy in Canada has nothing at risk."

The Springfield municipal program has been a focus of the FDA since Albano unveiled it in July. Importing prescription drugs from Canada is illegal, yet the FDA has declined to enforce the prohibition for individual consumers. The purchases have increased over the last four years as Americans desperate to reduce their medicine costs have found discounts as low as 50 to 80 percent on brand-name drugs north of the border, a result of Canadian government price controls. The US House has passed a bill that would make Canadian sales in the United States legal. The proposal is hotly opposed by the FDA and industry, which say American consumers could be exposed to counterfeit, expired, or improperly stored medicine from Canada.

It was against this backdrop that the FDA, using an assumed name and address, took action last month against Springfield's supplier of Canadian drugs, CanaRx Services Inc., based in Windsor, Ontario. The FDA said the sting resulted in a room-temperature batch of insulin that should have been delivered refrigerated. Hubbard said the package was not insulated but declined to release other details.

In the United States, some diabetics say insulin ordered from domestic mail-order companies often shows up at their doorstep at room temperature.

Concord author Philip Luber said he tried mail-order insulin for his daughter in 1999. The insulin that arrived via Federal Express, he said, was not refrigerated and arrived lukewarm. After his daughter began injecting the new batch, her glucose levels did not fall sufficiently -- evidence, he believes, that the insulin had been degraded by extreme heat during shipment. Luber persuaded his insurance company to allow him to purchase the insulin at a local drugstore instead. "The packages they were using were called insulated packages. It had layers of something in it, bubble-wrap or other insulation," he said. "But if you stick any kind of package in a hot truck for a couple of days in the middle of August, it doesn't matter."

For at least the past five years, US drug companies, wholesalers, and mail-order pharmacies have joined forces to oppose a set of proposed national prescription-shipping standards that would include the use of temperature sensors in packaging to tell consumers if their mail-order prescriptions had been exposed to extreme heat or cold. Without such sensors, proponents say, patients have no way of knowing if the drugs arriving on their doorstep were baked in a truck in the Arizona desert or frozen solid in the belly of a cargo plane.

"The concern has always been that when a mail-order pharmacy ships, it's being sent to the consumer under uncontrolled conditions," said Eric C. Sheinin, vice president for standards development at US Pharmacopeia, the standard-setting group.

US mail-order companies are generally regulated by individual state boards of pharmacy following US Pharmacopeia guidelines.

The FDA's Hubbard said the agency's rules establish US Pharmacopeia as the standard-setting entity for the operation of pharmacies, including national-scale pharmacies that ship across state lines. But US Pharmacopeia said it has no shipping standards, which has been a source of concern among some US Pharmacopeia officials. A 1997 study by the organization, in which test packages were shipped to 32 states, demonstrated that 26.1 percent of mail-order drugs were exposed to "excessive heat" of 104 degrees or more, well above the tolerance for insulin, for example. A 1995 study found that temperatures in St. Louis mailboxes reached 136 degrees.

Manufacturing guidelines for insulin say it should be stored in a refrigerator, although it can be kept safely at room temperature for up to 28 days. It loses effectiveness when it is exposed to greater than body temperature. The problem for mail-order consumers is that there is no way to tell by looking at the product if it has been heated beyond tolerable levels. Freezing insulin renders it almost completely ineffective, but there are telltale signs of freezing, such as a cloudy appearance.

The National Community Pharmacists Association has called on the federal government for greater regulation of Internet mail-order pharmacies, to no avail, said John M. Rector, the association's general counsel.

US Pharmacopeia has repeatedly proposed national guidelines to safeguard drugs in shipment, including the insertion of temperature sensors into packages of sensitive prescriptions like insulin and synthetic hormones. Those proposals have been defeated by "push-back from industry," which holds seats on the US Pharmacopeia governing bodies, Sheinin said. The organization's leadership plans to unveil a fresh set of proposals within two weeks.

The FDA's director of pharmacy affairs, Tom J. McGinnis, said the FDA would enforce whatever standard US Pharmacopeia adopts. Thus far, he said, the agency has not seen the need for independent action.

"FDA looked at this issue in the past, at least 10 years ago, when mail-order pharmacies started getting big," he said, "and we didn't see any degradation of strength, quality, and purity at that time."

The Pharmaceutical Care Management Association, which represents mail-order pharmacies, and the largest mail-order pharmacy, Medco Health Solutions Inc., declined to comment on US Pharmacopeia's proposals for temperature sensors. In the past, according to copies of industry newsletters, mail-order pharmacies, wholesalers, and drug manufacturers have said that requiring sensors would present an unfair regulatory burden, raise handling costs, and increase the likelihood that consumers would return drugs to mail-order retailers. "Mail-order pharmacy sources are already appropriately regulated by state boards of pharmacy," said Tim Brogan, a spokesman for the Pharmaceutical Care Management Association.

Medco Health Solutions, a subsidiary of drug maker Merck & Co., said mail-order pharmacists take great pains to make sure drugs arrive in good shape. Medco spokeswoman Ann Smith cited several measures including overnight or expedited shipping, iced or gel-packed insulated containers, and follow-up calls to an insured patient to see if the package arrived on time.

"We believe that our protocols are extremely rigorous," she said.

Christopher Rowland can be reached at

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