Out-Law News 1 min. read

UK web site warned by FDA against drug sales to US


The US Food and Drug Administration (FDA) has written to several on-line pharmaceutical suppliers, including one based in the UK, warning them that their sales to US citizens could be illegal. In a statement, the FDA said it was taking these steps “to protect the American public against potentially useless or harmful drugs to treat anthrax infection that are being marketed by foreign web sites in defiance of US laws.”

The agency has issued warnings to 11 internet vendors in Italy, Canada, Portugal, Canada and other countries, which are offering to US consumers ciprofloxacin, the generic name for the drug Cipro. The FDA claims it is unable to determine whether these products were made in accordance with US specifications and therefore concludes that their sale and distribution in the US may be illegal.

Ashok Kumar of MastersMarketing.com based in Harrow, England, expressed surprise at the FDA’s action. He told OUT-LAW.COM,

“We have been legally exporting pharmaceuticals to the US for 13 years. All the drugs we export to our US customers are within the FDA-approved pilot scheme of 1988. Yet the FDA is suddenly saying that all our exports to the US ‘may be detained and subject to refusal of entry’. This seems like a massive overreaction by the FDA which, if not addressed quickly, could have a very damaging effect on our business.”

The FDA claims that it “cannot provide adequate assurance to the American public that the drug products ordered from [MastersMarketing.com] are the same products approved by the FDA.” However, Mr Kumar commented:

“This is ridiculous. All the drugs we send out are in their original packaging as we receive them direct from internationally-recognised manufacturers.”

The FDA is also informing regulatory officials in the countries in which the internet pharmacies operate that these “potential violations” are taking place. Mr Kumar concludes,

“Many members of the general public in the US will be upset by this action from the FDA. The cost of these drugs inside the US is prohibitive for many people. Sites like ours give the public access to legal, affordable drugs. Surely members of the public should have the right to buy products for their own health from overseas?”

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