Criminal access to APIs must be cut off in a way that does not infringe generics companies’ right to buy chemicals, a top US prosecutor told In-Pharmatechnologist.com.
In counterfeiting prevention, “the biggest thing is access to API,” said Samuel Louis, a recently retired US attorney who worked with Pfizer, Merck, Eli Lilly and the FDA to take down drug counterfeiters. “That’s been part of our discussion – whether there is a method to safeguard APIs.”
However, he said, efforts to prevent APIs reaching the counterfeiters who make fake versions of branded drugs entering the supply chains also need to consider the right of generics manufacturers to freely access chemicals:
“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.”
When In-Pharmatechnologist asked the European Generics Association (EGA) if restricting access to chemicals would discriminate against generics firms, its Senior Manager, Quality and Regulatory Affairs, said the organisation supports the fight against counterfeits and believes in “collaborative efforts” across the industry.
“In the EU, since the entry into force of the Falsified Medicines Directive (FMD) in January 2013, manufacturers can only use APIs from distributors, importers or manufacturers which have been registered with the competent authorities where they are established,” said Julie Marechal-Jamil.
“This comes in addition to the common industry practice by which companies develop a thorough understanding of their API supply chains and manage them very closely, applying principles of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).”
Although GMP and GDP were designed to safeguard the consistency of substances, they also document the handling of materials and so are useful to regulators inspecting the supply chain for illegal diversion, she said.
‘Barrels labelled API’
Aside from the purchase or theft of active chemicals, criminal counterfeiters have a second way of exploiting the API supply chain, Louis told us: by smuggling finished counterfeit medicines internationally in shipments labelled as API containers.
This method was used by Kevin Xu, a counterfeiter sentenced to six-and-a-half years in prison in 2009 for one of the biggest scams of its kind.
Agents from the US Department of Homeland Security met Xu in a Starbucks in Bangkok in 2007, posing as buyers for the illicit medicines, Louis told In-Pharmatechnologist.com.
“Mr Xu offered the agent a large number of drugs. He further indicated he was placing pharmaceutical drugs in barrels that were labelled as API. So [that is how] he was getting these drugs into the UK. Then he said that he wanted to use the same process to get drugs into the USA.”
After Xu’s arrest, Louis swapped intelligence with the UK MHRA (Medicines Health and Regulatory Agency) about this smuggling method, which was used to distribute fake Zyprexa, Plavix and Casodex in the UK.
“Mr Xu would put the drugs in barrels and they would be labelled as pharmaceutical ingredients. Once they were in the barrels, they were already sealed. So customs at Luxembourg would never open and inspect them.”
When we asked if this API scam could be happening in the US, Louis replied customs could not inspect every package.
“Say someone ordered a 90-day supply of pharmaceutical product that could come in a very small package. Sometimes that can escape detection then and there, but if it’s on a regular basis within a six-month period from the same location going to the same person or company, one of those packages may be inspected.”
US mail inspections have resulted in arrests for pharmaceutical counterfeiting, such as seizures in San Francisco in 2011 which led to the conviction of En Wang .