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Counterfeiting

DOJ prosecutor: is there a way to secure APIs from counterfeiters?

By Fiona Barry , 13-Feb-2014

An illegal factory in Colombia washes empty vials before reuse in the production of counterfeit Tazocin, a Pfizer antibiotic.
An illegal factory in Colombia washes empty vials before reuse in the production of counterfeit Tazocin, a Pfizer antibiotic.

A US  attorney who worked with Pfizer, Lilly and Merck to jail drug counterfeiters says cutting off criminal access to active pharmaceutical ingredients (APIs) is key.

In counterfeiting prevention, “the biggest thing is access to API,” said Samuel Louis, who retired as deputy criminal chief at the US Department of Justice last November. “That’s been part of our discussion – whether there is a method to safeguard APIs.”

The need to block illegal supply had to be balanced against pharmaceutical companies’ rights to access, he told us:

“Of course you can have a generic version of a lot of these drugs, so there is an argument APIs should be available to everyone. But there has to be a way to make sure an API doesn’t end up in the hands of certain individuals.

Drug counterfeiters frequently use either too much or too little of an active ingredient. Louis said he had encountered counterfeit erectile dysfunction drugs containing both the active ingredient of Pfizer’s Viagra, but also of Lilly’s Cialis.

Toxic excipients used to bulk out fake medicines can also make them “life-threatening,” he added. “During my investigation I’ve seen sheet rock (drywall) that’s normally used for the interior of buildings, or yellow road paint.

‘Off the books’ fakes

Pfizer’s deputy global chief of security recently told In-PharmaTechnologist.com its drugs had been counterfeited in “deplorable” illegal facilities – “places you wouldn’t walk into.

But as well as these makeshift factories, Louis told us he had come across illicit pharmaceutical production taking place at night within legitimate premises.

Some pharmaceutical companies have manufacturing sites, say, in China. So you have legitimate runs of pills that are made at those factories.

Then after the factory closes you might have workers who come in and utilise the same equipment to produce pills that are not authorised.

But pursuing these criminals is less of a priority for law enforcement than the manufacture of more dangerous fake medicines off-premises, he told us.

That product is still considered counterfeit – because it was not authorised – but it has less of a concern for us because it would not contain [unknown API] products.

‘Not going to end’

Aside from limiting access to APIs, Louis said firms will need to adapt their packaging and formulations in ways that are harder for criminals to replicate.

I’ve noticed over the years, as you change the technology, they are just as adept. They buy the authentic pill, then they ‘reverse engineer’ it using scientific devices to determine its active ingredients.”

Most pharmaceutical companies will have to modify their manufacturing process to include some type of metal in their packaging.” Another method to outsmart counterfeiters could be altering a pill’s formulation in a way that distinguishes it from fakes, he said.

Big pharma is in agreement that despite their efforts, the market for counterfeiting will never disappear.

The profits are just so great, counterfeiting is not something that’s going to end. The pharmaceutical industry and governments have to work hand-in-hand.

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