To help stem the tide of counterfeit drugs, the Obama administration has recommended that Congress push for a national track-and-trace system. It's one of several pharma-related recommendations in an Executive Branch effort to protect intellectual property.
The track-and-trace system recommendation is a tall order. Such systems for drugs--and food--have been on the table for years, with states (California), other countries (Turkey and Abu Dhabi, for example), and world regions (Europe) largely taking the implementation lead.
But delays to these efforts, such as when California extended its mandate deadline to 2015 and the FDA last month "hit the reset button" on its initiative, promote the idea that this is a big, messy, complicated, long-term undertaking.
The Executive recommendations follow a review of IP laws and "deficiencies that could hinder enforcement." The review generated 20 recommendations for legislative changes that aim to increase enforcement effectiveness. In addition to the track-and-trace system, they include increasing maximum sentencing "particularly for counterfeit drug offenses;" requiring notification by importers and manufacturers when they find fakes; and expanding the Ryan Haight Internet Pharmacy Consumer Protection Act to include drugs containing no controlled substances.
- read the White House blog
- here's the IP enforcement legislation recommendations document
- see this article on the FDA effort
- here's background on the IP enforcement effort