Keeping It Real - Pharmaceutical Executive


Keeping It Real

Pharmaceutical Executive

Novartis has a multi-pronged approach. First, it has developed an early warning system consisting of intelligence sources that report any time there's a counterfeit problem, even if it's not a Novartis product. "We monitor what the other companies are doing and the problems they're having, because if somebody's having a problem in a particular country, we can guess that we're going to have a problem, too, eventually," Christian explains.

To avoid last-minute complications when a situation arises, Christian has developed contacts with law enforcement, regulatory, and health authorities in countries with known counterfeiting operations. "In many countries, the authorities don't devote the manpower to the situation," he says. "But if you come in after a three-month investigation with the clandestine lab, print shop, and suspects identified, you can get a prosecutor and the law enforcement to come in and make the case, and get some headlines and pictures in the paper."

In addition, Novartis tries to support the judiciary all the way through "because the worst thing that a company can do is walk away after the arrest or seizure, and not worry about the prosecution," Christian explains. "We try and hold their hands through the whole process."

RFID: Where R We?

In 2004, FDA freed industry to experiment with and pilot new labeling systems using radio frequency identification (RFID) to track product through the supply chain. RFID systems served two purposes: They permitted authentication of product on the item and package level and made it easy-to-establish an electronic pedigree.

Pfizer, Purdue, and a handful of other pharma companies tested RFID on expensive and highly counterfeited drugs such as Oxycontin and Viagra, touting the system as the future of security. At the same time, states such as California and Florida began mandating item- and package-level tracking, and the establishment of an electronic pedigree system to account for all packages as they move through the supply chain. The form of serialization to be used was not stated, but RFID did gain support as an easy, albeit expensive, means of scanning large quantities of drugs at one time.

There was just one hiccup—industry could not retool its entire distribution chain in time to meet California's January 2009 deadline. Now pharma has a few more years to get ready, and while some companies are well ahead of the curve, others are praying that the federal government will jump in with a national standard for e-pedigree

"I don't personally have much confidence in RFID," says Christian. "Back in 2004, the FDA task force was looking for an answer to satisfy Congress.They didn't really have one, so they came out and said RFID will solve all our problems in a couple of years. It hasn't, and it won't. It's an inventory management tool. It may help with the security of products from a diversion point of view, but 99 percent of [RFID] out there is not on the product, it's on the packaging."

According to Robin Koh, chief strategy officer at serialization company Supplyscape, one of the biggest problems with RFID is the cost/benefit ratio. Downstream supply-chain partners stand to benefit the most from RFID, but the manufacturer eats most of the costs. Still, Koh insists that pedigree is still one of the best methods of securing the supply chain.

"The best thing about a pedigree component is that it doesn't travel together with the physical item," Koh says. "Even if you steal the physical object, you won't know what the certificate is."

Merging serialization and security, labeling firm Mikoh has developed an adhesive label that supposedly cannot be defeated by heat, cold, or moisture. The label can be merged with an RFID tag, two-dimensional barcodes, or any other kind of pedigree tracking device. In order to open a box of drugs, the label must either be damaged or destroyed. The company is now working on a battery-powered label that records a time-stamp the moment the package is tampered with.

"We thought we had some good traction going with the California pedigree people, then when Schwarzenegger signed the bill that pushed off the deadline, there was a collective sigh of relief," says Mikoh vice-president of business development Steven Van Fleet. "In my mind, it was the wrong answer, because we still have counterfeit and diverted gray-market drugs, and people are getting sick and dying, and we seem to get hung up on, 'Jeez, we just dodged a technology bullet.' We're not really addressing the key issues here, so we continue to plod along."


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