House set to vote on plan for reimporting drugs into U.S.
WASHINGTON (Reuters) -- The U.S. House was set Wednesday for a final vote on a plan to allow U.S.-made prescription drugs to be reimported from other countries where they are often much less expensive.
The legislation would let pharmacists and wholesalers buy U.S. brand-name medicines in countries with lower prices, such as Canada, and resell them at a discount in the United States. Currently, only manufacturers can reimport prescription drugs.
With rising drug prices a key election-year issue, reimportation proposals passed by wide margins in the House and Senate earlier this year as lawmakers in both parties lined up to back the idea, despite fierce opposition from drug makers.
But Democrats and the White House now charge Republicans with watering down the final version, saying it will allow drug companies to maintain high prices through restrictive contracts and manipulation of labeling requirements.
"I don't think there's any question this isn't going to help one person in this country," said Senate Democratic Leader Tom Daschle. He said President Clinton was "contemplating" a veto of the broader 2001 agriculture spending bill to which the provision is attached.
The Senate could take up the bill later Wednesday.
U.S. consumers typically pay at least 30 to 50 percent more for prescription medicines than consumers in other countries, in large part because the United States is the world's only major nation without price controls on drugs.
The legislation would allow the reimportation into the United States of Food and Drug Administration-approved drugs made in FDA-approved facilities.
Pharmacists and wholesalers reimporting drugs would have to meet quality standards for shipment and storage at least as strict as those already in place for manufacturers, as well as FDA-overseen testing and record-keeping requirements.
Drug industry groups say that will not be enough to protect consumers from dangerous, fake or adulterated medicines.
"Repealing landmark consumer protection legislation in order to reimport prescription medicines will increase risks to American consumers without resulting in any significant savings for them," said Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America.
Democratic critics of the legislation, however, say it contains loopholes that render it practically unworkable.
The bill bars U.S. drug makers from entering into contracts with foreign customers that prevent the sale or distribution of drugs for later reimportation. But, the critics say, that will not stop manufacturers from contractually binding those customers to agree not to resell the drugs below U.S. prices.
They also note the legislation does not require manufacturers to allow importers and wholesalers to use their FDA-approved product labels -- without which reimported drugs could not be legally sold in the United States.
Under the bill, drugs could initially only be reimported from a limited number of countries, including those in the European Union, Canada, Japan and Australia, but excluding Mexico and countries in Latin America.
The reimportation provisions would also expire after five years unless Congress acted to extend them.
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