Regulatory Focus™ > News Articles > How a New Anonymous Network May Complicate FDA's Effort to Stop Counterfeit Drugs

How a New Anonymous Network May Complicate FDA's Effort to Stop Counterfeit Drugs

Posted 25 April 2014 | By Alexander Gaffney, RAC

Counterfeit pharmaceutical products are among the most ominous challenges global regulators, including the US Food and Drug Administration (FDA), face on a day-to-day basis.

FDA routinely goes after counterfeiters, working to dismantle their operations by seizing their web properties. For example, it has regularly worked with other regulators and law enforcement officials as part of Operation PANGEA, a massive operation which has taken down thousands of websites since its inception.

Indeed, going after the websites used to sell counterfeit medicines has been key to FDA's anti-counterfeiting strategy, which has used the strategy to increasing effect in recent years.

Websites Targeted by FDA as Part of PANGEA

Enter: The Dark Market

But as Wired reports, that strategy may meet its limits in the form of new technology.

After a major black-market drug market known as Silk Road was shut down last year by the US Federal Bureau of Investigation (FBI), security-minded enthusiasts began to ponder the choke points of distribution networks, writes Wired.

At issue are two things:

  • First, an Internet Service Provider (ISP) can shut a website down (or de-list it) when contacted by authorities, severing its connection from the Internet.
  • If the first option-a favorite of FDA and PANGEA-fails, then officials can physically seize a server hosting the website, removing it from the Internet and obtaining any data it once held (which might be used to track users, owners, suppliers and individual orders).

While FDA may have been able to rely on the FBI or federal marshals being able to seize servers as a last-resort option, Wired notes new technology may make it more difficult to stop some types of counterfeiting in the future.

New technology, still in the proof-of-concept phase, called "DarkMarket" would operate as a peer-to-peer system without any "central authority" such as a server.

In other words, if the system ever works, users might be able to create their own black-market pharmacy to sell directly to other users of the system. FDA would be required to go after each marketer of counterfeit goods on a case-by-case basis-assuming it could ever track them down. Paired with the use of alternative currencies like Bitcoin, tracking orders may be even more difficult as well.

At the end of the day, that may make FDA rely heavily on its new anti-counterfeiting technologies, such as its new Counterfeit Detection Device Number 3 (CD3), which analyzes drugs using nearly a dozen wavelengths of light, to identify fake medicines and stop them from reaching consumers.

As Wired concludes, the technology underlying DarkMarket is all but here and in final form already. Whether or not the regulators of tomorrow will be able to cope is another question entirely.

Wired Article on DarkMarket

Regulatory Focus newsletters

All the biggest regulatory news and happenings.