The Safety of Imported Drugs, Increasingly Manufactured by Abroad by U.S. Companies

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> The Safety of Imported Drugs

>

> The allure of importing cheap prescription drugs from Canada and other

> advanced nations is proving irresistible, despite federal laws against it

> and stern warnings from the Food and Drug Administration that imported

> drugs may not be safe. Individual consumers have been buying drugs from

> abroad for some time now. The new wrinkle is that state and local

officials

> have become interested. Illinois has asked regulators for permission to

> import drugs from Canada, California has been exploring the possibilities,

> and the city of Springfield, Mass., has already started importing drugs

> from Canada for its workers and retirees, in open defiance of the F.D.A.

It

> is a sign of how untenable the drug industry's outrageously lopsided

> pricing strategies have become.

>

> Imported drugs can be a great bargain because pharmaceutical manufacturers

> exact their highest prices from American consumers and sell the same

> products for much less in foreign markets, where prices are driven down by

> price controls or hard bargaining by governments. Under a law passed in

> 1987, it is generally illegal for anyone other than the manufacturer to

> import such drugs into the United States. That law was passed to protect

> Americans from counterfeit or unsafe drugs at a time when prices were not

> an issue. But now prices are a huge issue, providing good reason to search

> for ways to ensure that the imports are safe.

>

> The F.D.A. says it cannot guarantee the safety of imported drugs because

> counterfeiters might slip bogus products into the supply lines or shippers

> might fail to handle and store medicines properly. Indeed, a sting

> operation by the drug agency caught Springfield's Canadian supplier

> shipping insulin at room temperature instead of keeping it chilled. But

the

> mayor has been buying Canadian insulin for his son's diabetes and intends

> to continue.

>

> It is not generally recognized that we already import a huge volume of

> drugs from abroad. While the drug industry has been railing against the

> dangers of foreign imports, it has increasingly transferred its own

> production to foreign factories to save on labor costs. The drugs are made

> in plants inspected by the F.D.A., with processes approved by the F.D.A.

If

> the government can do this for the drug companies, surely some combination

> of federal and state regulatory agencies can devise a system to make drug

> imports safe. The agencies might, for example, allow only a limited number

> of foreign pharmacies or wholesalers to supply the drugs, inspect and

> monitor those suppliers closely, and require strict paper controls to

> follow the progress of all shipments.

>

> The bigger question is whether allowing drug imports would really work as

> intended. Some drug companies have already announced that they will cut

> back on their shipments to Canada if the Canadians send too many drugs

back

> here. In that event, Canadians would be the losers, no longer able to get

> the drugs that were shipped instead to Americans. Nobody really knows what

> will happen if Congress passes legislation to encourage drug imports. Our

> own guess is that it could provide a useful nudge to the industry to

revise

> its global pricing policies to spread the burden more fairly.

> http://www.nytimes.com/2003/09/20/opinion/20SAT1.html?th

>