Current FDA Procedures for Counterfeit Medicines

The FDA also took part in an international campaign week in November 2009 in opposition to counterfeit products on the Internet, titled International Internet Week of Action (IIWA). The Office of Criminal Investigations (OCI) was involved on behalf of the FDA, in collaboration with the CDER and the Office of Enforcement, which is a part of the Office of Regulatory Affairs (ORA).

In a press release from 19th November 2009 the FDA wrote that a total of 136 websites had been found which were clearly associated with the sale of non-approved, or wrongly labelled, medicines to customers in the USA. The websites of pharmacies in the USA and Canada were not involved.

The FDA issued 22 warning letters to operators of these websites.

According to FDA Commissioner Margaret A. Hamburg, the medicines supplied by illegal pharmacies on the Internet were often counterfeit, contaminated, not approved, or contained an inconsistent amount of active ingredients. These medicines present a great danger to users.

The full press release from the FDA can be found here.

Since there is an increasing number of websites which are supplying dangerous or illegal medicines, a total of 25 other countries along with the USA, took part in this international campaign week to combat online trading in counterfeit and illicit medicines (IIWA), which went by the name of "Operation Pangea II".

The activities were coordinated by Interpol and IMPACT, which is the World Health Organisation's (WHO) "International Medical Products Anti-Counterfeiting Taskforce".

In the countries involved, a total of around 995 packages were seized and 72 websites were suspended.

Sabine Kopp (WHO) and Janice Soreth (FDA) will provide you with all the latest news on WHO and FDA activities in a conference at the University of Würzburg, "Strategies against Counterfeit Medicines", which is to be held in Würzburg, Germany, from 26-28  April 2010. Janice Soreth, from the new FDA office in Europe, will be reporting on procedures, on how the FDA is dealing with counterfeit products and how they are to prevent counterfeit medicines in the future.

You can take a look at the full programme for the conference in Würzburg here.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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