FDA Says 90% of Imported Mail-Order Drugs Hazardous

September 30, 2003 (PLANSPONSOR.com) - With prescription drug purchases from Canada on the political hot plate, the Food and Drug Administration (FDA) said nearly 90% of the imported mail-order drugs stopped at the borders in a special crackdown by government agents were potentially dangerous.

>Of the 1,153 drug products inspected, 1,019 were illegal.   Although foreign sources claim to have drugs identical to those approved by the FDA, the seized drugs showed many problems.   They   included drugs in different versions from those approved by the FDA, counterfeit drugs, drugs with dangerous interactions, animal drugs not approved for human use, drugs previously withdrawn from the US market, drugs with dangerous side effects, controlled substances and narcotics, FDA officials said.

>At mail centers in New York, Miami, San Francisco and Carson, Ca,. the FDA and US Customs and Border Protection (CBP) searched approximately 100 packages per facility per day.   The packages were examined if they were from countries from which drugs are known to be exported.

>The FDA has long proclaimed a concern with importing drugs, claiming that the imported drugs may cause a health risk.   The discoveries in the recent “blitz” exams by the FDA and CBP show this may be, in fact, the case.  

“There is no evidence that unapproved imported drugs are becoming any safer or more reliable,” said Mark B. McClellan, Commissioner of Food and Drugs.   “Given FDA’s limited resources and authorities to detect and block potentially unsafe imports, we are concerned about any measure that would increase the flow of these unapproved drugs, or provide easier channels for them to enter the United States.”

>Of the drugs inspected, most were exported from Canada (15.8%), a country which is being looked to by a number of states as a possible solution to rising drug costs, but which McClellan has maintained should not be seen as a solution. (See  MN Governor Looks Up For Lower Drug Prices, Iowa Looks To Hop on Canadian Drug Bandwagon , Illinois Gov Pushes For Canadian Drug Purchases ).  In the past McClellan has said programs like that of Springfield, Mass., by endorsing prescription purchasing from Canada, are putting participants lives at risk (See  Springfield, Mass. Pushes Canadian Drug Order Program).

The latest sting is not the first time the FDA has investigated American companies purchasing Canadian prescription drugs.  In September, the Justice Department asked an Oklahoma judge to issue an immediate injunction against Rx Depot, a chain of 85 storefront businesses that helps process drug orders in Canada. Justice lawyers, working with the FDA, argue the company’s role as a middleman makes it a de facto pharmacy that endangers patients by selling “unapproved” products (See   FDA Tells Canadian Drug Store Fronts To Cease and Desist ).

>Additionally, i n August, the FDA allegedly found that the supplier of Springfield, Massachusetts’ Canadian drug shipments was improperly handling insulin, saying when the insulin arrived via regular mail, it was at room temperature, instead of chilled and delivered via overnight mail as it is supposed to be handled to ensure its effectiveness (See  FDA Stings Springfield’s Canadian Drug Supplier ).

-Alison Cooke

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