Anti-counterfeiter sees collaborating regulators, public naming/shaming

NEW YORK - Drug counterfeiting is "the perfect crime," said Guy Villax of Portuguese API developer and manufacturer Hovione. "The patient swallows the weapon and is unaware of the crime."

Hovione is a member of the Rx-360 consortium, which targets patient safety via a global monitoring system for product quality and authenticity. The year-old consortium is in the process of establishing a cascade of shared facility-audit data, demonstrating that each supply chain link has inspected its supplier operations.

"Falsified medication is a bigger business than narcotics," Villax said in a presentation at Interphex. But in 24 out of 27 European countries, the crime is no more serious than trademark infringement on t-shirts. Sanctions need to be tougher, he said.

Fakes of Viagra and Lipitor--the top sellers among counterfeits--are just the beginning. The big problem is falsified APIs. "Once they hit the supply chain, they become part of legal medications. They are very difficult to tell apart, and in some cases I don't think you can."

He cited the 2008 incident involving heparin as a well-known case. The incident ultimately led to the United States Pharmacopeia's adoption of new manufacturing controls and modification of the reference standard for the drug's unit dose, as a hedge against contamination.

Villax said he "remains mystified" about how the contaminated heparin case went on for so long. "Between November 2007 and February 2008, 150 people died," he said. "Why didn't QA [the quality assurance groups at the drug companies using the API in their products] do its job? Why wouldn't a competent purchasing agent notice the price difference in heparin from China and ask, 'What's going on here?'"

Fortunately, some evidence of corrective actions is beginning to appear. And he expects such actions will become more effective over time.

"Regulators will work more to collaborate and share information," Villax said. "Recent joint facility inspections by U.S. and EU regulators, by U.S. and Irish regulators, and by U.S. and Italian regulators are an effort in building confidence that regulatory authorities in different parts of the globe can share data and rely on the data they receive from one another."

Villax also said that he anticipates "more naming and shaming," like the March case of clopidogrel made in India. European authorities recommended publicly that Swiss drugmaker Acino recall products containing the API and named other makers of blood pressure treatments whose API comes from the same source. Conversely, Villax said he expects to see rewards for manufacturing compliance, coming from both regulators and the market.

"Regulators have lost their patience," said Villax. Warning letters are now arriving four months after inspections that yield manufacturing violations, rather than the 18 months more typical of the past in Europe.

Such prompt, focused attention from regulators could result in greater transparency among drug-making companies. He cited as an example the highly publicized viral contamination at a Genzyme facility in Boston, which became news last summer, and the airing of its GMP violations. The company remains highly accessible today to shareholders and the press, providing both the good news and the bad in the still-unfolding story. "This is where we're going," said Villax.

He also suggested that the Internet will prove itself an ally to patients, who will become savvy about drugmaking and the drug supply chain. "Patients will defend themselves by looking for information. They will read every label and demand to know the origin of the tablet, its API and excipients."

Labels will start to carry such information, he said. "If not mandated by regulators, the market will demand it. All you need is one company to do it, and to advertise that it's making the information available on its label, and the others will follow." - George Miller

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