Counterfeit Alli Warning from the FDA – We Should Be Using Technology for Easier Identification

Below is the release from the FDA and today it is a jungle out there with making sure we don’t have counterfeit products. A while back I wrote a few posts about using Microsoft Tags for identifying items that had been recalled. In giving this some further thought, this process could also be beneficial for finding counterfeits as well.

It has been all over the news about the FDA not having an adequate way of identifying recalls and tags could also play a role in this area too. If pharma and medical device companies collaborated on the tags used on products for identification, this could really help, as any Smartphone, Iphone or BlackBerry can be used as a scanner and this is public information we want known to all, but unfortunately not every one of us catches everything we need to read today.

With Tags, anyone can create one to point back to a website and that in itself could be used by a counterfeiter, but first of all there’s going to be a data trail on access here, so it would also lead investigators to the culprits sooner. In addition, with a collaboration and some specific encryption built into the tags, and FDA emblem could also show on the phone validating the tag as being official, in other words if you do not see the Tag showing the FDA on it, question the drug or product as that tag could only be available to authentic pharma, device or other companies.

Counterfeiters would not have access to high level encryption to fake this, so in other words a collaborated data base of approved products would show the product is not fake. Another way of having this information authenticated too would be to have all the information point to the data base of Tags at the FDA too. Again, if a fake tag were created, it would be traceable too and lead to faster identification of those trying to put counterfeit products out there.

Business Intelligence software running queries could identify someone trying to use a “fake” tag. Also, there would the very obvious things to look for, a product with no tag at all would be something to question. it would certainly stand to make it easier for the consumer to identify a fake tag. This type of technology is already being explored to have your phone enter information into your PHR too, so there’s already some research and development on going in this area for authentication. The worst case scenario for a consumer as far as availability of information would be to establish a “Tag” account for authentic information, but we do this all the time anyway on websites.

RazCode/Windows Tags – Bar Coding to Add Information to PHRs, EHRs, and More…

So again, with a little programming here and some IT expertise, the Tag system from Microsoft could also stand to help identify counterfeit medications, drugs and devices that float out on to the market. You can try the RAZCode image on the page here and it will not get you anywhere if you don’t have authorization for a simple example.

I do have my “Tag” on the blog here so try it and see how easy it works as this is open and public information. Tags can even be programmed to dial a phone number from your cell phone, neat idea for business cards in that area. In the meantime, here’s the warning from the FDA about the counterfeit Alli products below. BD

FDA NEWS RELEASE

For Immediate Release: January 18, 2010

Media Inquiries: Tom Gasparoli, 301-796-4737, thomas.gasparoli@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers about Counterfeit Alli
The counterfeit products contain controlled substance sibutramine

The U.S. Food and Drug Administration is today warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).

Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.

Consumers began reporting suspected counterfeit Alli to GSK in early December 2009. GSK has determined that the counterfeit product has been sold over the internet. However, there is no evidence at this time that the counterfeit Alli product has been sold through other channels, such as retail stores.

The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:

Outer cardboard packaging missing a “Lot” code;

Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);

Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;

Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;

Contains larger capsules with a white powder, instead of small white pellets.

Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these counterfeit products to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.