Counterfeiting, says Johnson & Johnson’s Ron Guido, is a form of flattery. “If you don’t have counterfeits in your business, chances are you don’t have a good brand,” said Guido, J&J’s VP for global brand protection, speaking at the ISPE annual meeting in Dallas last week. In other words, a successful product/brand (Gucci, let's say) is the apple of a counterfeiter's eye.

One could say that supply chain security is the most critical issue facing drug manufacturers today—and perhaps facing our healthcare system as well. The supply chain is at the heart of healthcare’s greatest problems—drug counterfeiting and adulteration, shortages of key medicines, and of course escalating medical costs. Without security of supply, none of these challenges can be addressed.

I spent the first part of this week in Toronto, Canada (light years away from the staid, dull town I remember visiting as a kid----with rush hours that easily rival New York’s.  I almost missed my flight home!) to attend USP’s annual science meeting.

A key theme was protecting the pharmaceutical supply chain.  A number of scientists discussed the analytical tools that are being developed to help law enforcement specialists identify fakes.  Quite a few of these presentations focused on handheld Raman, but more on that, and the conference, later.

We appreciate Pfizer's efforts to educate the public on the danger of shady websites peddling countefeit products--but, caution, this one is not for the weak of stomach. Thanks to Drug Channels' Adam Fein for spotting this rat.

--PWT

Janet Woodcock, head of FDA’s CDER, strikes me as the type of person you’d want in charge during a crisis.  And that’s exactly where FDA, and CDER, have found themselves this year, so I’m not surprised that Dr. W. was reassigned from her post of Chief Medical Officer and Deputy Commissioner to head up CDER.  Using the triage imagery of the Emergency Room, running the Critical Path initiative is important, but maintaining control of CDER, drug review and inspections, is urgent.

The prospect of California's e-pedigree and drug serialization legislation being pushed back to 2015 (from 2009, then 2011) has the industry breathing a sigh of relief, or is it a sigh of frustration? Drug Channel's Adam Fein, back from his self-imposed blog-cation, weighs in. Perhaps most relevant, says Fein, is the fact that California seems deferential to a national track-and-trace system.

But is that national system likely to materialize, driven by FDA? Probably not, says Fein in his Sept. 3 blog entry.

--PWT

An fyi: Steve Simske of Hewlett-Packard offers a nice, unbiased (though HP-oriented) perspective on current anticounterfeiting measures from his Security Printing and Imaging blog. Definitely worth a view. Today he reminds us of the potential benefits of using stable isotopes as a way of authenticating processes by which APIs and drugs are made.

It's a topic we've covered quite a bit, with some help from John Jasper of Molecular Isotope Technologies, who's worked with FDA, J&J and others to advance the technology:

J&J Looks at Stable Isotopes for Process Analysis

Isotope Analysis Expands Its Forensic Niche

Stable Isotopes Find a New Role in PAT

--PWT

The California Board of Pharmacy has shown that it is willing to get tough with pharmacies that may have exacerbated the impact of the heparin crisis. It has fined nearly 100 hospital pharmacies who did not properly adhere to Baxter's heparin recall earlier this year.

The California state assembly has passed SB 1307, a measure that sponsor Sen. Mark-Ridley Thomas says is designed to ensure patient safety, but will in actuality yet again push back the proposed compliance date for drug manufacturers and distributors to meet electronic pedigree requirements to 2015--rather than the 2011 (and 2009) previously designated.

California's inability to nail down a firm compliance date and hold manufacturers' feet to the fire will certainly heighten calls for federal pedigree legislation. More to come . . .

--PWT

At the American Chemical Society national conference last weekend, Rensselaer Polytechnic researcher Dr. Robert Linhart announced that his team may have built the first fully synthetic heparin. Whether or not you believe that the possibility of another contamination crisis of natural raw heparin exists, the potential for a heparin supply independent of the whims and worries of the global supply chain, not to mention the global pig population, is certainly welcome news.

Is synthetic heparin feasible on a large scale? Yes and no, says one of Linhart's collaborators, professor Jian Liu at the University of North Carolina. The science is there to produce synthetic heparin at the milligram level, and almost there to produce it at the kilo level, Liu told me this morning. But a lack of investment and low market incentive may collude to limit the short-term outlook for engineered heparin.

"We need someone who's willing to serve as partner to expedite production," Liu says. Right now, the researchers are talking with several smaller biotech firms about development for clinical trials. They have not yet been approached by larger pharma companies.

Synthesizing heparin involves introducing sulfa groups into polysaccharides derived from E. Coli bacteria, Liu says, in order to produce an key enzyme for heparin production. The cost of this process is 10 to 100 times less than making heparin from human enzyme, Liu says.

There are a couple technical issues to be worked out before synthetic heparin could be produced at greater rates, much less at a rate to satisfy the current market demand of 30 to 40 tons per year. The first, says Liu, would be improving the yield of the starting materials. The second would be scaling up the current lab procedures to an industrial level--an "engineering problem," says Liu.

And there are financial issues. Even though heparin prices have risen this year to more than $5,000 per kilo, the cost is not prohibitive to warrant a major push towards an alternative. The incentive is not there.

Unless another crisis occurred. While Liu and colleagues certainly don't wish for this, the impetus for their research, which began in 2005, was that the heparin supply is vulnerable. Three main factors are involved in control of the supply, Liu notes: the global pig supply, the heparin harvesting and purification process, and the analytical control. While measures by FDA, other regulatory bodies, and heparin suppliers and manufacturers to establish greater control have been "pretty impressive," according to Liu, the current way of making heparin will always be vulnerable to environmental (e.g., porcine disease) and human (e.g., purposeful adulteration) factors.

Liu likens maintaining control of the heparin supply to maintaining antidoping procedures for Olympic athletes. "You have to know what you're looking for," he says. But just as athletes find ways to circumvent drug tests, there may always be heparin contaminants that will fall outside of materials inspection parameters.

Synthetic heparin created in a GMP environment from fermentation to packaging would certainly eliminate these concerns. The best-case scenario, however, is that synthetic heparin could be ready for patient use within 4-5 years, Liu says. But this is only if there are investment dollars for development and production scale-up.

Pharmaceutical Manufacturing, PharmaManufacturing.com, and On Pharma have been covering, and analyzing, the heparin case since it began. In September, we'll take a closer look at the lessons learned from the heparin crisis, and what all manufacturers must do to ensure safe and efficient supply lines.

--Paul Thomas