Security Printing and Imaging : FDA

Colorcon On-Dose ID Anti-Counterfeiting Technology

StevenSimske — Tue, 17 Nov 2009 16:42:00 GMT

In July, the US Food and Drug Administration (FDA) provided "guidance advocating greater use of physical chemical identifiers (PCIDs) in drug formulations as a cost-effective way of authenticating genuine products from fakes."

Colorcon has responded with its "On-Dose ID tagging technology", for labeling individual drug tablets (although I didn't at time of writing see mention of it at http://www.colorcon.com/home ).

"The microscopic tags, which are incorporated into immediate-release film coatings for oral solid dose forms, can hold encrypted information ranging from lot and batch numbers to logos, text and other brand identification symbols. Tablets labelled with the 75 – 110 micron sized tags can be read using the portable “Vision” optical viewing system developed by Colorcon’s partner ARmark Authentication Technologies."

Please see the full article on in-Pharma's site here:

http://www.in-pharmatechnologist.com/Materials-Formulation/Colorcon-rolls-out-On-Dose-ID-anti-counterfeiting-tech/?c=JiBz%2FX6W8971ORXdDDv0AQ%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

File this under "special approach, special reader needed."

Cheers,

Steve

Puzzling Advice From the FDA: Add Chemicals to your Drugs

StevenSimske — Thu, 16 Jul 2009 14:52:00 GMT

The FDA is advocating the addition of chemicals to pharmaceuticals to improve the identification of counterfeits.

http://www.in-pharmatechnologist.com/Industry-Drivers/FDA-advocates-food-pigments-and-flavours-to-combat-counterfeits/?c=JiBz%2FX6W897ybeGc6YCjow%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

This is puzzling advice in several ways. First off, the article states:

"IMS health recently estimated that the counterfeit drugs 'market' generates almost $800bn annually and is growing at almost 6 per cent a year." This is either hyperbole or simply poor reporting. $80bn annually is the correct current estimate.

Next, the summary of the advice is stated:

"The Food and Drug Administration’s (FDA) new document argues that incorporating PCIDs into drug formulations could be a cost effective way of differentiating genuine products from fakes. The agency went on to say that PCIDs used in drugs should be pharmacologically inactive and suggests that: 'food additives, colorants, or excipients with established safety profiles,' would be ideal candidates. While in common with other anti-fake labelling methods, PCIDs can be easily detected in the laboratory, their big advantage over traditional methods is that they can be readily identified by patients, healthcare practitioners and pharmacies."

There is certainly a trend to include less, rather than more, exogenous chemicals -- dyes, expedients, etc. -- in food and drugs. So, the FDA advice bucks that trend.

Also, adding PCIDs "with established safety profiles" by definition means that the list of PCIDs to add is public knowledge. This makes it easier for the would-be counterfeiter to obtain those PCIDs, doesn't it?

Regardless, the use of PCIDs would presumably follow one of two strategies:

(1) Controlled substance, in which case the PCIDs used should only be sold by authorized suppliers to authorized buyers. The type of fraud to prevent in that case, then, is the insidious insider who orders PCIDs and sells them for profit to his counterfeiting buddies.

(2) Security by obscurity, in which case the PCIDs should not be published. This is also susceptible to insidious insiders, however, and certainly makes authentication more difficult.

Using PCIDs, in addition, may complicate the authentication process--requiring the deployment of specialized analysis equipment and personnel. The FDA is certainly enamored with nanotechnology, and this may relate. However, track and trace and authentication through the appropriate combination of security printing (remember that tablets can be printed on and linked to the information on the package through the application of the appropriate inference model) and RFID seems, to me, easier, more cost-effective, more scalable, and more effective.

The full draft of the guidance is posted here:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM171575.pdf

Some highlights salient to the discussion:

"There are various available means for presentation and detection of PCIDs (e.g., photolithography, holography, laser scanning devices, and excitation/fluorescence detection). Many identifying characteristics, such as pigments or flavors, could be easily observed by patients, healthcare practitioners, and pharmacies. Some could require the use of instrumental detection (e.g., a scanner or photometric detector)."

"To minimize toxicological risk, FDA recommends using permissible direct food additives, including those affirmed as generally recognized as safe (GRAS), or those ingredients listed in the FDA Inactive Ingredient Guide (IIG)."

What are your thoughts? Any comments? Please post below! Thanks,

Steve

FDA seeking 19% budget increase for supply chain security

StevenSimske — Sun, 31 May 2009 04:11:00 GMT

Apparently, this post was lost in the transition to the new blogging application (which took place May 15-22). The FDA earlier this month announced plans to increase field testing and other inspection of imported food and pharma goods in response to the recent salmonella and drug scares.

The FDA budget document states:

“In the complex and rapidly changing environment driven by globalisation, FDA cannot rely on traditional approaches – inspection and sampling at the US border – to protect Americans and ensure the safety of medical products. FDA will use traditional and innovative mechanisms that include FDA inspections and field exams, integrated federal-state oversight, and greater access to inspection data and results acquired from trusted foreign regulatory authorities.”

The plans include a more than 100% increase in the number of field tests of imported drugs, and a boost in the inspections of high-risk foreign and domestic facilities by nearly 20%.

See the overview article at:

http://www.in-pharmatechnologist.com/Industry-Drivers/FDA-requests-19-funding-boost-to-secure-supply-chain/?c=JiBz%2FX6W896enue4TQ%2BDEw%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

Cheers, Steve

Label liabilities, or when is more information simply noise?

StevenSimske — Wed, 11 Mar 2009 03:24:00 GMT

We live in the age of data, not information. Which is to say that the amount of digital data doubles every 18 months. But there is not necessarily a smarter set of people assimilating, digesting, diagnosing, learning from this data. Facebook, Twitter, MySpace--you get the idea. Sure, there's a lot of 1's and 0's there, but what does it mean? Sleater Kinney deified (albeit sardonically) digital data in "God is a Number", saying "Looking for some kind of heart inside this great machine, I don't get an answer except 01 1 01 1 01..."

In light of "$7m damages award to a Vermont woman who sued Wyeth", Wyeth could reasonably ask when is more data information, and when is it noise.

An article on the court decision is at http://www.in-pharmatechnologist.com/Industry-Drivers/Wyeth-s-appeal-failure-could-impact-US-drug-labelling, and it states that the ruling "means that drugmakers are still vulnerable to State consumer liability lawsuits despite FDA approval for a drug and its labelling".

Wyeth retorts: "When lay juries are permitted to second-guess the experts at FDA on the benefits and risks of particular medicines, the result is uncertainty for patients and doctors alike about how and when to use prescription drugs".

The bigger question is, how much should be printed on the label (or on the attached data sheets)? Do people read those folded inserts or the 2 point font on the labels? Is it information, or is it just unread data; that is, noise?

Perhaps the label itself should include the following items: (1) quite overt printed information about known (and FDA prescribed) issues; (2) the inserted text covering the FDA regulations; and (3) a website (or printed target--e.g. a barcode--to point your mobile device to a website) that contains by state/province/jurisdiction additional information. This affords important information to be with the product even offline while allowing jurisdictions to post their specific data dynamically online.

Maybe then we can turn to Sting and the Police instead of Sleater Kinney for the final word: "Too much information running through my brain, Too much information driving me insane." I'd rather have information than just a bunch of 1's and 0's...

Cheers,

Steve

Not Gone Without a Trace

StevenSimske — Thu, 26 Feb 2009 17:12:00 GMT

Is Track and Trace dead for 6 years with the Ridley-Thomas legislation allowing pharma 6-7 years to bring mass serialization to their shipments? Hardly. As Gregg Metcalf of Nosco noted today in his keynote address at the Graphics of Americas Brand Protection Conference (http://www.graphicsoftheamericas.com/conferences/bpc.html), other legislation is in the works, which may even speed up adoption in California.

My friend and HP colleague, Ray Dickinson, provided this link, for example:

http://www.pharmaceuticalcommerce.com/frontEnd/main.php?idSeccion=1081

This article (worth a read) begins: "While some wind went out of the sails of the national effort to implement item-level tracking of pharmaceuticals after California postponed its e-pedigree rules in September, new developments continue to push the topic along. These events are occurring both in Washington (at FDA and, potentially, in the U.S. Congress) as well as in Brussels, Belgium, home of both the European Parliament and the GS1 organization, whose GS1 Healthcare Group is producing a lot of paper (if not actually standards) on its campaign for identifying and tracking everything related to healthcare products."

Indeed, the Obama administration seems very interested (look at the headlines) in changing the game for Healthcare. So, there will be government regulation. The GS1, skilled at working across international boundaries (thus, the "lack" of standards--they provide solutions, not laws), makes sense for commerce. Stay tuned. Much more in the works here, and more to post in the coming few weeks.

Cheers,

Steve

Do You Recall This Much Recall?

StevenSimske — Wed, 26 Nov 2008 05:04:00 GMT

We are rolling into the Thanksgiving Holiday here in the States, which traditionally coincides with a modicum of gluttony. Historically, the time right after harvest was the time of festivals--might as well eat the food and let it ferment inside you rather than your cellar!. Given the recent news and FDA announcements, one wonders what is safe to eat at all...

The youngest might not want their formula:

http://news.yahoo.com/s/ap/20081126/ap_on_he_me/infant_formula_6

Don't put tomato sauce on your veggies:

http://www.fda.gov/oc/po/firmrecalls/wegmans11_08.html

Heck, don't have the veggies, period!:

http://www.fda.gov/oc/po/firmrecalls/stopnshop11_08.html

Don't try cheese as an alternative dessert:

http://www.msnbc.msn.com/id/27914220/

Or an alternative cheese as an alternative-alternative!:

http://www.fda.gov/oc/po/firmrecalls/panos11_08.html

Don't try a dietary supplement in place of the big meal:

http://www.fda.gov/oc/po/firmrecalls/balancedhealth11_08.html

Or try fat loss capsules to keep the weight off!:

http://www.fda.gov/oc/po/firmrecalls/fashionsanctuary11_08.html

And don't try rewarding the pooch with an extra helping:

http://www.petcare.mars.com/

Guess it's time to start that diet! Either that, or time for a reliable food track and trace mandate. On that sour (sweet, bitter, salty, MSG or other taste, for that matter) note...

Happy Thanksgiving!

Cheers, Steve

ePedigree Delay a Sign of An Eventual Supply Chain U.N.?

StevenSimske — Thu, 20 Nov 2008 05:49:00 GMT

I have been remiss in discussing the delay in the California ePedigree until 2015. This has been interpreted as a long-term delay for track and trace and overall product safety. For a nice overview and analysis of the problem, see http://www.industryweek.com/ReadArticle.aspx?ArticleID=17793.

However, ePedigree initiatives are underway by the WHO, FDA, EU, AQSIQ (China), GS1 and other standards/regulatory organizations. A full serialization+pedigree requirement may be delayed until 2015, but it is unlikely that ePedigree will not already be in place before then. Recent passing of PRO-IP and Country-of-origin labeling (COOL) legislation in the US indicates that the US,too, will continue with initiatives before 2015.

The delay of California ePedigree legislation, moreover, may be indicative of another passing of the torch. Much as the recent Presidential (and Congressional) election results likely signal a more collaborative, less "independent" US foreign policy, the delay in ePedigree may signal a more collaborative, less independent nation-to-nation legislation in the future.

Will the big players--WHO, FDA, EU, AQSIQ, GS1, ISO, and others--work together to create a reasonable roadmap for product track and trace, pedigree and provenance? In effect, create a "United Nations" for track and trace? I, for one, hope so. With the increasingly convoluted supply chains for virtually all products resulting in chaos during recall, fraud and even normal node-node shipping situations (how many retailers can confidently tell you everywhere a product has been on its way to their shelves?), how long can it be before the legitimate market says, "enough is enough"? Plus, a universal process will reduce confusion, lower cost, and improve response time around the planet.

Is the current combination of counterfeiting, diversion, factory overrun, smuggling, return fraud and other supply chain crime the commerce equivalent of the two World Wars? A series of events so drastic that the set of collective players decides to band together into a United Nations to try to prevent such a meltdown in the future? (I realize the United Nations is by no means perfect--but we have been without nuclear combat for 63 years...). Maybe so. And maybe the delay in the California ePedigree shows that the US, rather than defining the path forward, is willing to work with the rest of the Supply Chain United Nations in formulating the optimum set of requirements moving forward.

-Steve

The Unflat Earth Strikes Again--Inspection Unflatness

StevenSimske — Sat, 25 Oct 2008 05:17:00 GMT

For this interesting article on U.S. inspection of pharma manufacturing plants, I thank my friend Pipo Caban, a systems, supply chain, manufacturing and pretty much all-around expert at HP:

http://www.newsobserver.com/1573/story/1263668.html

The article states:

"13 years is...the time it would take U.S. inspectors to visit each of 3,249 foreign manufacturing plants that make medications for the American market, according to congressional investigators...The Food and Drug Administration is nowhere near to closing an oversight gap so foreign facilities get the same scrutiny as domestic plants. Pharmaceutical factories in the U.S. get a federal inspection every 2.7 years, on average. Although the FDA will soon be placing inspectors in China and India, 'given the growth in foreign drug manufacturing for the U.S. market, and the large gaps in FDA's foreign drug inspection program, significant challenges remain,' the Government Accountability Office said in its report."

In other words, the Unflat Earth, and not the Flat Earth, strikes again. Motivation to move your manufacturing overseas? How about you get inspected 1/5 as often?

I have posted about the Unflat earth in previous blogs; specifically, the July 5th and 6th blogs this year. I'll revisit these now in light of this information.

On July 5th, I noted:

"Evasion of the local laws. Sure, every large company claims they're simply 'staying competitive' with their competition as they try to squeeze the last penny out of their costs. The truth is, most of this cost is due to finding out how the Unflat Earth (the real one, which still has countries, with different laws and rules and requirements in them) works and using it to advantage. Can you find a country with no health care costs? Great, put your assembly line there. Can you find a country with relaxed environmental laws? Excellent place for any pollutant-producing manufacturing operations. Companies aren't necessarily choosing where to place their employees based on a Flat Earth--that's just spray-on gloss to hide the Unflatness they're actually exploiting."

Add inspection to this list.

On July 6th, I added:

"The earth is not flat...yet. If you want to have engaged partners around the world, you have to work to even the playing field. Eventually, healthcare, environmental, auditing, compliance and other factors involved in selecting a spot to design, manufacture and assemble products will be more uniform. The world will be, truly, more flat. However, until that date, respectful citizens of the planet will work to improve the working conditions and environmental impact of doing business everywhere. Even if only out of self-interest, this strategy makes sense."

I also noted that increased costs of fuel might make offshoring certain types of production, manufacturing and assembly less profitable. Of course, that also makes inspection more costly, so those two will continue to trade off (if I still save more money by being inspected far less, paying less employee benefits, and not having to perform as many environmental-safety tasks, I can absorb those increased fuel costs).

But, the article goes on, into even more disturbing areas:

"The report found that the FDA isn't even sure how many foreign facilities are producing for the American market. One government database suggests it's 6,760. Another, which government officials believe to be more accurate, says about 3,000."

and...

"When FDA inspectors find problems at an overseas plant, the manufacturers usually take steps to fix them. But the report found that it can take as long as four or five years for the FDA to conduct a follow-up inspection."

I'm feeling some serious unflatness here. No wonder so many industries have been coasting down the hill of offshoring. It brings an entirely new track and trace problem to the fore. Forget about track and trace of the individual items in your supply chain (mass serialization). Forget about track and trace of all the locations your supply chain goes through (ePedigree). When you aren't even sure within a factor of two how many foreign facilities are producing for your market, you need to start at the most elemental level--find out who your partners are and get engaged with them. A very good way to ensure quality is for there to be a vested interest by all parties in the supply chain.

As Pipo notes, "[There are] so many regulations and restrictions for the locals but we are letting others control our health." In other words, the unflat regulations drive production overseas, where concern over our health is almost certainly--if not inevitably--less than it would be for locals, whose families might be customers.

Again, I am not against offshoring. Differences in distribution of raw materials, talented humans, and needs argue for responsible offshoring in most industries. But this works best if those distant workers are engaged, empowered, and "bought in" to the company performing the offshoring. It's not just about long-term economic viability of the partnership--it's about security and health.

-Steve