THURSDAY, Jan. 29, 2004 (HealthDayNews) -- As federal authorities continue to target illegally imported prescription medications, two U.S. cities say they plan to stick with programs that let employees buy drugs from Canada.
The defiant stance by officials in Springfield, Mass., and Montgomery, Ala., followed a U.S. Food and Drug Administration announcement Tuesday that a "blitz" inspection of almost 2,000 imported drugs revealed most lacked FDA approval and could pose serious health risks.
The unapproved drugs -- discovered in November inspections -- included foreign versions of FDA-approved drugs, recalled drugs, drugs requiring close physician monitoring and addictive controlled substances, the FDA said. The drugs, the agency added, lacked assurances of safety, effectiveness, quality and purity.
"We don't think it's worth compromising safety for price," FDA Commissioner Mark B. McClellan told a news conference Tuesday. "We think patients should not be subject to 'buyer-beware' conditions like this, where they're getting products, often from people out to make a profit with no substantial medical expertise."
Officials in Springfield and Montgomery, however, said they saw no danger in city employees and retirees taking the imported medications, saving both the cities and the patients money. Springfield and Montgomery appear to be the only cities helping employees get imported drugs, though some states are considering doing so.
"We have had this program going on for well over a year and have had zero complaints," said Jeff Downes, an aide to Montgomery Mayor Bobby Bright.
Downes said 200 to 300 city employees and retirees pay an average of 50 percent less than what U.S.-based pharmacies charge for the same drugs.
"They're made by the same manufacturer, they have the same content, they are the same drug," Downes said. "They may have slightly different color or slightly different name."
"We just feel like this a win-win situation" for the patients and the city, he added. "The only losers in this battle are pharmaceutical companies -- the manufacturers."
Officials in Springfield took the same stance.
"We haven't had anybody who didn't get anything other than what they ordered, and, from what I hear, it's always what they had been getting from U.S. suppliers," Christopher Collins, the city's insurance program director, said. "The employees seem to be very satisfied with the service they've been getting."
Some 2,800 Springfield employees and retirees still receive prescription medications from CanaRx Services Inc., Collins added. Buying from CanaRx, he said, has resulted in prescription drug savings of about $1 million since July, and individual prescriptions have cost about 40 percent less than what U.S. pharmacies would charge.
The FDA, however, continues its crackdown. Last week, the agency issued a warning to three Texas companies to stop processing orders for Canadian drugs. The companies are Expedite-Rx, which helps Montgomery patients get Canadian drugs, as well as two other Temple-based companies, SPC Global Technologies Ltd. and Employer Health Options Inc.
In its warning letter, the FDA said the companies' actions violate U.S. law, "present a significant risk to public health" and "mislead the public about the safety of the drugs that are obtained through your program."
"We cannot tolerate shady operations that enrich a few while exposing many patients to the risks of dubious imports," McClellan said in a statement about the Jan. 22 warning.
The FDA gave the three companies 15 working days to bring their operations into compliance with U.S. law and threatened legal actions that could include seizure and an effort to seek an injunction.
In September, the FDA said it had sent a similar warning letter to CanaRx. CanaRx, which the FDA said had been based in Detroit, has since shut its U.S. offices and moved to Canada, the Associated Press reported.
The continuing FDA crackdown also has led to a federal judge's ruling that an Oklahoma company that sold drugs from Canada be shut down. U.S. District Judge Claire Eagan in November ordered Rx Depot to cease operations and close 85 company-operated storefronts nationwide.
"The defendants are able to offer lower prices only because they facilitate illegal activity determined by Congress to harm the public interest," Eagan said.
In a statement posted on its Web site, Rx Depot said it would appeal and urged people to contact members of Congress to "voice your outrage to this blatant injustice."
More governments on this side of the border could soon be helping employees get drugs from Canada. Boston Mayor Thomas M. Menino has pledged to proceed with the city's plans to buy cheaper drugs for city workers and retirees. And officials of about a dozen states -- including Oklahoma, North Carolina and Ohio -- met last month in Atlanta with representatives of Canadian drug companies.
But in announcing the results of the latest inspection blitz -- conducted along with U.S. Customs and Border Protection -- the FDA cited "serious risks posed by the illegal importation of prescription drugs." The November 2003 inspection found 1,728 unapproved drugs at mail facilities in Buffalo, Dallas, Chicago and Seattle and at courier hubs in Memphis and Cincinnati.
The FDA said the inspection uncovered:
- Improperly labeled drugs: Many lacked adequate labeling or instructions for proper, safe use. Some had no instructions or had them only in a foreign language.
- Controlled substances: These included addictive drugs such as codeine and Valium. They can be dangerous and have abuse potential.
- Foreign versions of FDA-approved drugs: Many of these pose safety concerns, and their use requires close supervision of a health-care professional. These drugs included a foreign version of the blood thinner warfarin, which must be carefully administered and monitored by a health professional to prevent serious bleeding, and a human growth hormone that can worsen diabetes and elevate pressure in the brain if used inappropriately or in excessive doses.
- Drugs that require initial screening or periodic monitoring: For example, the acne drug Isotretinoin, marketed in the United States as Accutane, can cause birth defects if taken by pregnant women, and U.S. prescribers have to attest that testing confirms a patient is not pregnant. These drugs also included lithium carbonate, an anti-psychotic also used to treat manic depression. The drug requires careful monitoring of serum levels to avoid life-threatening toxicity.
- Drugs that can have significant interactions with other drugs: These
include cholesterol-lowering Zocor, Viagra and the tricyclic antidepressant imipramine.
More information
For more on both sides of the imported drugs controversy, visit the U.S. Food and Drug Administration or AARP.
