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Diet Drug Report for June 2006 -- News About Diet Drugs
 
Can Americans Get Diet Pill Acomplia from Europe This Summer?
 

If all goes according to plan, Sanofi-Aventis plans to launch the highly anticipated diet pill Acomplia (rimonabant) in Britain and Germany in mid-summer.

However, the U.S. Food and Drug Administration is not expected to act on approval of Acomplia for many months, and it is not likely to be available in the United States at least until sometime in 2007.

So the question our sister publication, Acomplia Report, reports it is now receiving from U.S. readers is: Can I have someone buy Acomplia for me in Europe, and ship it to me in the United States?

Let us start by noting that Acomplia will be a prescription drug in Europe as it would be, upon approval, in the United States. It is not expected to be available in 2006 in any of the countries around the world where prescription drugs can be purchased without a prescription.

So the first hurdle a prospective American purchaser would have to surmount would be the challenge of obtaining a prescription from a doctor in one of the European countries where Acomplia is expected to be initially available.

Even if you have a relative, as several emails have suggested, who would attempt to obtain Acomplia in Britain or Germany, the second point to note is the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. sections 331(d), and 355(a)), specifically prohibits importation of any drugs that have not received FDA approval.

The FDA says in theory a Customs officer from the U.S. Customs Mail Division would examine a package and set it aside if it appears to contain Acomplia or any other FDA-regulated article that might either represent a health fraud or be unapproved for sale in the U.S.

The FDA then audits those packages set aside by Customs.

But what does this mean in practical terms?

The FDA concedes that "because the amount of merchandise imported into the United States in personal shipments is normally small, both in size and value, comprehensive coverage of these imports is normally not justified."

The agency says it focuses its enforcement resources "more on products that are shipped commercially, including small shipments solicited by mail-order promotions, and less on those products that are . . . shipped by a personal non-commercial representative of a consignee."

This would appear to suggest that if you have a relative or friend who is somehow able to obtain Acomplia for you in Europe, the chances of a package getting through to you are probably fairly high.

That, of course, leaves open the question of why anyone would want to take a prescription drug that (1) has been brought into the U.S. illegally, (2) has not been approved by the FDA as safe, and (3) would be taken outside the care of a doctor.

The memories of fen-phen, the combination of diet drugs fenfluramine and phentermine which was never approved as safe by the FDA but nevertheless was taken by (and jeopardized the health of) millions, appear to run short.

 
 
 
 
 

 

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Last Updated: 06/01/2006 Copyright 2004-2006 Medical Week News, Inc. All Rights Reserved