May 1st, 2007

FDA Warns On Counterfeit Drugs And 24 Web Sites Peddling Them

The FDA issued a warning today that 24 apparently related Web sites may be involved in the distribution of counterfeit prescription drugs. The drug is Xenical, a weight loss medication made by Hoffmann-La Roche.

The warning was relayed via a release at the FDA web site here, and contains the names of the sites. The FDA has provided pictures of the counterfeit Xenical, but unfortunately didn’t think to put pictures of bona fide product side-by-side with the counterfeits. Modern technology is such that many counterfeits are virtually indistinguishable from the legitimate drug.

Distribution of counterfeit drugs raises liability concerns for any pharmacy or distributor that sells them, and potentially for any manufacturer that turns a blind eye to the distribution practices for its own drugs so that they trade on the gray market in pharmaceuticals.

More on counterfeit drugs, including commentary on pending legislation, can be found on this blog by clicking on the label in the sidebar or this link: Counterfeit Drugs.


April 24th, 2007

Counterfeit Drugs Update – Trying to Track The Goods

A few other blogs have noted developments on the continuing story of how counterfeit drugs enter our pharmaceutical supply chain that are worth noting:

Adam Fein at Drug Channels in RFID Un-Hype covers the failure of the drug industry to embrace radio frequency identity tags as a means of tracking drugs as they wind their way through an often extended supply chain. The extended supply chain is safety weakness as it increases the chances for counterfeit infiltration. The subject is also covered by Ed Silverman at Pharmalot as he notes that the much ballyhooed RFID as a solution to tracking drugs in the supply chain appears dead in the water.

The failure of RFID comes as no surprise to me. When I previously spoke before the FDA’s Counterfeit Drug Task Force a few years back, I urged non-technology solutions. The remedy for a weak supply chain is to actually limit the number of hands the drugs pass through, not try to document a dozen different owners of the drugs. The more people that touch the drug, the greater the chance for infiltration of counterfeits (or destruction of the drug through negligent handling). Counterfeiters will always be around to try and corrupt the supply chain, for as Willy Sutton might have said, that’s where the money is. One day, some distributor that bought mystery medicine out of the gray market will be looking at dead bodies and trying to feign ignorance of the problem.

And on a related note, Jayne Juvan (Juvan’s Health Law Update), reports on an appeal to the Second Circuit Court of Appeals in Rx USA Wholesale v. Department of Health and Human Services, Food and Drug Administration. This dealt with an injunction against the FDA forcing compliance with the rules regarding the drug pedigrees (that’s the track of the actual drugs, discussed above). The FDA has now filed its brief, and Jayne has a copy of it along with a synopsis.

See also from this blog (with yet more links) :


February 19th, 2007

Counterfeit Drugs Update

Two articles worth noting. The first is a December recap of how laws are changing in the 50 states over the last couple of years (thanks to Juvan’s Health Law Update). The second is a general article this past weekend on the subject of fake drugs geared more for members of the general public that may not have been exposed to the issue in the past (thanks to Adam Fein’s Drug Channels):

I last discussed counterfeit drug legislation in New York and on the federal level at these links:


February 16th, 2007

FDA Alert – Misrepresented Drugs Bought Online

Since I write a bit on the subject of counterfeit drugs, as a result of a matter I handled…

FDA Alerts Consumers to Unsafe, Misrepresented Drugs Purchased Over the Internet

The Food and Drug Administration (FDA) has become aware that a number of Americans who placed orders for specific drug products over the Internet (Ambien, Xanax, Lexapro, and Ativan), instead received a product that, according to preliminary analysis, contains haloperidol, a powerful anti-psychotic drug.

Reports show several consumers in the United States have sought emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms and muscle stiffness after ingesting the suspect product. Haloperidol can cause muscle stiffness and spasms, agitation, and sedation.

Therefore, the agency is reissuing its warning to consumers about the possible dangers of buying prescription drugs online. FDA urges consumers to review the FDA Web site for information before buying medication over the Internet. You can read about where to buy drugs for erectile dysfunction on the Internet at this link.

FDA laboratory analysis of the misrepresented tablets is ongoing, but preliminary analysis indicates they contain haloperidol, the active ingredient in a prescription drug used primarily to treat schizophrenia. FDA learned about these mislabeled and potentially dangerous products after their recipients complained to a U.S. pharmaceutical manufacturer.

The origin of these tablets is unknown but the packages were postmarked in Greece. Photographs of the tablets in question and the shipping packages can be seen at [this link]. If the tablets received from an Internet seller resemble those in the photos and haloperidol was not specifically ordered, do not take these tablets. Instead, consumers should notify their health care provider and report the suspected products to FDA by submitting a product quality problem report at [this link].

Although the involved consumers have named several Internet Web sites where the products were purchased, identifying the vendors is difficult because of the deceptive practices of many commercial outlets on the Internet. FDA is investigating this illicit trade and plans to release appropriate information when it is available.

Taking medication that contains an active ingredient other than what was prescribed by a qualified health care professional is generally unsafe. FDA continuously warns U.S. consumers of the possible dangers of buying prescription drugs online and urges them to review the FDA Web site for additional information prior to making purchases of medication over the Internet (at this link).

For more on the problem of Counterfeit Drugs:


January 18th, 2007

Does Congress Understand the Counterfeit Drug Problem?

Last week bipartisan legislation was introduced, ostensibly aimed at drug safety, called the Pharmaceutical Market Access and Drug Safety Act of 2007. Does it really deal with drug safety? Nope. It is almost entirely about the importation of drugs from Canada and other countries.

The bill does nothing to plug the leaky supply chain that we have here that allows drugs to be swapped among the thousands of secondary wholesalers like pork belly futures. Indeed, the requirements of pedigrees for pharmaceuticals (a list of prior owners) has still not been fully implemented despite being authorized by Congress in 1987.

There is nothing in the bill about the most basic of safety issues, such as increased criminal penalties for counterfeiters, mandating pedigrees back to the manufacturer, and funding for the F.D.A. so that they can actually do random testing of drugs in the marketplace, recall them when needed, and do proper investigations.

Before Congress tries to deal with foreign drug supply systems, it should get a grip on our own, and enact Tim Fagan’s Law, which came about as a result of domestic counterfeiting.

More on the subject can be found at: