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(2) Security by obscurity, in which case the PCIDs should not be published.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