FDA negotiates details of tracking system to prevent counterfeit pills

In an effort to combat counterfeit drugs, the Food and Drug Administration trying to work out the details of a prescription medication tracking system in order to insert the proposal into the FDA user fee bill now being debated in Congress. 

There's no guarantee that the FDA and the healthcare and pharma industries--and their lobbyists--will agree on what the tracking system should entail before the Senate votes on the user fee bill. But it's possible that it could be included in the House-Senate conference version of the measure, Politico reports

The industry group Pharmaceutical Distribution Security Alliance wants to require pharmaceutical companies to include a serial number on each lot of drugs. Those handling the drugs throughout the distribution chain could check them against an electronic database to ensure their authenticity.

In addition to protecting patient safety, stakeholders have agreed to make a deal with FDA in order  to create some national uniformity as more and more states pass laws that require the tracking of prescription drugs. Thirty states has adopted such measures, according to an article in Pharmalot. California, for example, plans to require unique serial numbers on each pill bottle by 2015. That would be more costly for the industry than just labeling drug lots.

The lack of agreement among pharmaceutical companies, wholesalers and pharmacies about how to deal with the counterfeit drug problem has delayed the creation of a national tracking system, the Pharmalot piece says. For example, California originally passed its law in 2004, but implementation of the measure was postponed several times. In 2008, a number of stakeholders expressed support for the law, but several major drug makers and the CVS pharmacy chain were not on board.

To learn more:
- read the Politico article
- see the Pharmalot piece



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